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    Home > Medical News > Latest Medical News > The State Food and Drug Administration released the catalog of generic drug reference preparations (43rd batch)

    The State Food and Drug Administration released the catalog of generic drug reference preparations (43rd batch)

    • Last Update: 2021-07-31
    • Source: Internet
    • Author: User
    Tags

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    1
    2

    1.  
    Tacrolimus injection
    1ml:5mg
    Astellas Pharma Co.
    Ltd.

    1.  
    Rifaximin Tabiels/ Xifaxan
    200mg
    Alfasigma S.
    p.
    A

    1.  
    （20%）/ （15）/ （30%）
    Lipid Emulsion（20%）/Amino Acids（15）and Glucose（30%）Injection/ Clinomel
    1000ml[（20%）200ml；（8.
    5%,15AA）400ml；（30%）400ml]
    BAXTER S.
    A.
    S

    1.  
    （20%）/ （15）/ （30%）
    Lipid Emulsion（20%）/Amino Acids（15）and Glucose（30%）Injection/ Clinomel
    1500ml[（20%）300ml；（8.
    5%，15AA）600ml；（30%）600ml]
    BAXTER S.
    A.
    S

    1.  
    Levothyroxine Sodium Oral Solution /Thyquidity
    100µg/5ml
    EMP LEVO US BV

    1.  
    Clobazam Oral Suspension/ Onfi
    2.
    5mg/ml（120ml:300mg）
    Lundbeck Pharmaceuticals LLC

    1.  
    Estradiol Tablets
    1mg
    Barr Laboratories Inc

    1.  
    Proparacaine Hydrochloride Eye Drops
    0.
    5%（15ml）
    Akorn Inc

    1.  
    Famotidine and Sodium Chloride Injection
    0.
    4mg/ml
    Baxter Healthcare Corpration

    1.  
    Calcitriol Oral Solution
    15ml:15μg
    Validus Pharmaceuticals LLC

    1.  
    Colchicine Oral Solution/ Gloperba
    0.
    6mg/5ml
    Avion Pharmaceuticals LLC

    1.  
    Sildenafil Sitrate For Oral Suspension
    10mg/mL
    Upjohn EESV

    1.  
    Methotrexate Disodium Solution For Injection In Pre-Filled Syringe/Metoject、Metex
    50mg/ml
    medac Gesellschaft für klinische Spezialpräparate mbH

    1.  
    Enzalutamide Tablets
    80mg
    アステラス

    1.  
    Ketoprofen Cataplasms
    30mg,10cm×14cm

    1.  
    Tizanidine Hydrochloride Granules / Ternelin
    0.
    2%（1g2mg）
    サンファーマ

    1.  
    Domiphen bromide Buccal Tablets/Oradol
    0.
    5mg
    テバファーマ

    1.  
    Sodium Picosulfate Tablets/ラキソベロン2.
    5mg
    2.
    5mg
    ファーマ

    1.  
    Ketoconazole Cream
    2%, 30g/piece
    Janssen-Cilag Ltd
    No imported original research drugs
    UK listed

    1.  
    Levosimendan Injection
    Levosimendan Injection
    5ml:12.
    5mg
    Orion Corporation
    Original drugs marketed in China
    Original research import

    1.  
    Esmolol Hydrochloride and Sodium Chloride Injection
    Esmolol Hydrochloride and Sodium Chloride Injection
    100ml: 2g esmolol hydrochloride and 0.
    41g sodium chloride
    Shanghai Baxter Medical Products Co.
    , Ltd.
    Drugs produced in China by foreign original research companies that have been reviewed and determined
    Original research real estate

    1.  
    Gadolinium meglumine injection
    Gadobenate Dimeglumine Injection
    10.
    58GM/20ML (529MG/ML)
    Bracco Diagnostics Inc.
    No imported original research drugs
    American Orange Book

    1.  
    Dexrazoxane for injection
    Dexrazoxane for Injection/Totect
    500mg
    Clinigen, Inc.
    No imported original research drugs
    American Orange Book

    1.  
    Lenalidomide capsules
    Lenalidomide Capsules/Revlimid
    10mg
    Celgene Corporation
    No imported original research drugs
    American Orange Book

    1.  
    Lenalidomide capsules
    Lenalidomide Capsules/Revlimid
    25mg
    Celgene Corporation
    No imported original research drugs
    American Orange Book

    1.  
    Efavirenz Lamivudine Tenofovir Tablets
    Efavirenz Lamivudine and tenofovir Disoproxil Fumarate Tablets/Symfi
    Each tablet contains efavirenz 600mg, lamivudine 300mg and tenofovir disoproxil fumarate 300mg
    Mylan Laboratories Ltd
    No imported original research drugs
    American Orange Book

    1.  
    Potassium chloride oral solution
    Potassium Chloride Oral Solution
    20mEq/15ml
    (473ml)
    Genus Life Sciences Inc
    No imported original research drugs
    American Orange Book

    1.  
    Ramipril tablets
    Ramipril Tablets/
    Tritace
    2.
    5mg
    Sanofi Belgium
    No imported original research drugs
    EU listing

    1.  
    Ramipril tablets
    Ramipril Tablets/
    Tritace
    5mg
    Sanofi Belgium
    No imported original research drugs
    EU listing

    1.  
    Amorolfine Hydrochloride Liniment
    Amorolfine Hydrochloride Liniment
    0.
    05%
    Galderma International
    No imported original research drugs
    EU listing

    1.  
    Various oil and fat emulsion injections (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    1000 ml
    Fresenius Kabi AB
    No imported original research drugs
    EU listing

    1.  
    Various oil and fat emulsion injections (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    500 ml
    Fresenius Kabi AB
    No imported original research drugs
    EU listing

    1.  
    Various oil and fat emulsion injections (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    250 ml
    Fresenius Kabi AB
    No imported original research drugs
    EU listing

    1.  
    Various oil and fat emulsion injections (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    100 ml
    Fresenius Kabi AB
    No imported original research drugs
    EU listing

    1.  
    Aminolevulinic acid hexyl ester hydrochloride and special solvent for bladder perfusion
    Hexaminolevulinate Hydrochloride Powder And Solvent For Intravesical Solution/Hexvix
    85mg
    Ipsen Pharma Gmbh
    No imported original research drugs
    EU listing

    1.  
    Diquafosol Sodium Eye Drops
    Diquafosol Sodium Eye Drops/Diquas
    3% (5ml:150mg)
    Santen Pharmaceutical Co.
    , Ltd.
    No imported original research drugs
    Listed in Japan

    1.  
    Sucralfate Oral Suspension
    Sucralfate Oral Suspension /Ulcerlmin
    10ml:1g(10%)
    Fuji Chemical Industry Co.
    , Ltd.
    Unimported original research drugs
    Listed in Japan

    1.  
    Sodium picosulfate oral solution
    Sodium Picosulfate Oral Solution/Laxoberon
    7.
    5mg/ml
    Sanofi
    No imported original research drugs
    Listed in Japan

    1.  
    Clobazam tablets
    Clobazam Tablets/Frisium
    10mg
    Aventis Pharma Ltd
    No imported original research drugs
    UK listed
    10-86
    Riluzole tablets
    Riluzole Tablets/RILUTEK
    50mg
    Aventis Pharma SA /Sanofi Mature IP
    Original research import
    The license holder has changed, and the license holder Sanofi Mature IP is added after the change
    10-106
    Midazolam Maleate Tablets
    Midazolam Maleate Tablets/Dormicum
    15mg (calculated as C18H13C1FN3)
    Roche Pharma (Schweiz) Ltd.
    /Roche Pharma (Schweiz) AG/CHEPLAPHARM Arzneimittel GmbH
    Original research import
    The license holder has changed and the license holder Roche Pharma (Schweiz) AG/CHEPLAPHARM Arzneimittel GmbH has been added after the change.
    16-12
    Albendazole Tablets
    Albendazole Tablets/Shi Ke Chang Chong Qing
    0.
    2g
    Sino-U.
    S.
    Tianjin SmithKline Pharmaceutical Co.
    , Ltd.
    Original research and localized varieties
    The errata of the licensee is Sino-U.
    S.
    Tianjin SmithKline Pharmaceutical Co.
    , Ltd.
    21-40
    Concentrated zoledronic acid solution for injection
    Zoledronic Acid Concentrated Solution for Injection/Zometa
    5ml: 4mg
    Novartis Pharma Schweiz AG /Future Health Pharma GmbH
    Original drugs marketed in China
    The license holder has changed, and the license holder Future Health Pharma GmbH will be added after the change.
    Remark
    1.
    The generic names and dosage forms of the varieties listed in the catalogue that have not yet been marketed in China shall be subject to those approved by the Pharmacopoeia Commission
    .
    2.
    After the publication of the reference preparation catalogue, the varieties that have not been officially released will be subject to special research and will be released separately based on the research results
    .
    3.
    The reference preparations marketed in the EU include the same drugs marketed in the UK
    .
    4.
    Selecting non-imported reference preparations to carry out generic drug research should not only meet its quality requirements, but also meet the requirements of the current version of the Chinese Pharmacopoeia and related guidelines
    .
     
    　　State Food and Drug Administration
     
    　　July 22, 2021
    　　Medical Net, July 26, has been reviewed and determined by the Expert Committee of the Quality and Efficacy Consistency Evaluation of Generic Drugs of the National Medical Products Administration
    .
    The catalogue of generic drug reference preparations (the 43rd batch) is now released .
     
    　　Hereby inform
    .
     
    　　Attachment: List of generic reference preparations (forty-third batch)
    Serial number
    Generic name of the drug
    English name/trade name
    Specification
    Licensee
    Remark 1
    Remark 2

    1.  
    Tacrolimus injection
    Tacrolimus injection
    1ml:5mg
    Astellas Pharma Co.
    Ltd.
    Original drugs marketed in China
    Original research import

    1.  
    Rifaximin Tablets
    Rifaximin Tabiels/ Xifaxan
    200mg
    Alfasigma SpA
    Original drugs marketed in China
    Original research import

    1.  
    Fat emulsion (20%) / amino acid (15) / glucose (30%) injection
    Lipid Emulsion (20%)/Amino Acids (15) and Glucose (30%) Injection/ Clinomel
    1000ml[fat emulsion injection (20%) 200ml; compound amino acid (8.
    5%, 15AA) injection 400ml; glucose injection (30%) 400ml]
    BAXTER SAS
    Original drugs marketed in China
    Original research import

    1.  
    Fat emulsion (20%) / amino acid (15) / glucose (30%) injection
    Lipid Emulsion (20%)/Amino Acids (15) and Glucose (30%) Injection/ Clinomel
    1500ml[fat emulsion injection (20%) 300ml; compound amino acid (8.
    5%, 15AA) injection 600ml; glucose injection (30%) 600ml]
    BAXTER SAS
    Original drugs marketed in China
    Original research import

    1.  
    Levothyroxine Sodium Oral Solution
    Levothyroxine Sodium Oral Solution /Thyquidity
    100µg/5ml
    EMP LEVO US BV
    No imported original research drugs
    American Orange Book

    1.  
    Clobazam oral suspension
    Clobazam Oral Suspension/ Onfi
    2.
    5mg/ml (120ml:300mg)
    Lundbeck Pharmaceuticals LLC
    No imported original research drugs
    American Orange Book

    1.  
    Estradiol tablets
    Estradiol Tablets
    1mg
    Barr Laboratories Inc
    Internationally recognized drugs of the same kind
    American Orange Book

    1.  
    Proparacaine Hydrochloride Eye Drops
    Proparacaine Hydrochloride Eye Drops
    0.
    5% (15ml)
    Akorn Inc
    Internationally recognized drugs of the same kind
    American Orange Book

    1.  
    Famotidine Sodium Chloride Injection
    Famotidine and Sodium Chloride Injection
    0.
    4mg/ml
    Baxter Healthcare Corpration
    Internationally recognized drugs of the same kind
    American Orange Book

    1.  
    Calcitriol oral solution
    Calcitriol Oral Solution
    15ml:15μg
    Validus Pharmaceuticals LLC
    No imported original research drugs
    American Orange Book

    1.  
    Colchicine Oral Solution
    Colchicine Oral Solution/ Gloperba
    0.
    6mg/5ml
    Avion Pharmaceuticals LLC
    No imported original research drugs
    American Orange Book

    1.  
    Sildenafil Citrate Dry Suspension
    Sildenafil Sitrate For Oral Suspension
    10mg/mL
    Upjohn EESV
    No imported original research drugs
    EU listing

    1.  
    Methotrexate Disodium Solution For Injection In Pre-Filled Syringe/Metoject、Metex
    50mg/ml
    medac Gesellschaft für klinische Spezialpräparate mbH

    1.  
    Enzalutamide Tablets
    80mg
    アステラス

    1.  
    Ketoprofen Cataplasms
    30mg,10cm×14cm

    1.  
    Tizanidine Hydrochloride Granules / Ternelin
    0.
    2%（1g2mg）
    サンファーマ

    1.  
    Domiphen bromide Buccal Tablets/Oradol
    0.
    5mg
    テバファーマ

    1.  
    Sodium Picosulfate Tablets/ラキソベロン2.
    5mg
    2.
    5mg
    ファーマ

    1.  
    Ketoconazole Cream
    2%，30g/
    Janssen-Cilag Ltd

    1.  
    Levosimendan Injection
    5ml:12.
    5mg
    Orion Corporation

    1.  
    Esmolol Hydrochloride and Sodium Chloride Injection
    100ml:2g0.
    41g

    1.  
    Gadobenate Dimeglumine Injection
    10.
    58GM/20ML（529MG/ML）
    Bracco Diagnostics Inc.

    1.  
    Dexrazoxane for Injection/Totect
    500mg
    Clinigen, Inc.

    1.  
    Lenalidomide Capsules/Revlimid
    10mg
    Celgene Corporation
    No imported original research drugs
    American Orange Book

    1.  
    Lenalidomide capsules
    Lenalidomide Capsules/Revlimid
    25mg
    Celgene Corporation
    No imported original research drugs
    American Orange Book

    1.  
    Efavirenz Lamivudine Tenofovir Tablets
    Efavirenz Lamivudine and tenofovir Disoproxil Fumarate Tablets/Symfi
    Each tablet contains efavirenz 600mg, lamivudine 300mg and tenofovir disoproxil fumarate 300mg
    Mylan Laboratories Ltd
    No imported original research drugs
    American Orange Book

    1.  
    Potassium chloride oral solution
    Potassium Chloride Oral Solution
    20mEq/15ml
    (473ml)
    Genus Life Sciences Inc
    No imported original research drugs
    American Orange Book

    1.  
    Ramipril tablets
    Ramipril Tablets/
    Tritace
    2.
    5mg
    Sanofi Belgium
    No imported original research drugs
    EU listing

    1.  
    Ramipril tablets
    Ramipril Tablets/
    Tritace
    5mg
    Sanofi Belgium
    No imported original research drugs
    EU listing

    1.  
    Amorolfine Hydrochloride Liniment
    Amorolfine Hydrochloride Liniment
    0.
    05%
    Galderma International
    No imported original research drugs
    EU listing

    1.  
    Various oil and fat emulsion injections (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    1000 ml
    Fresenius Kabi AB
    No imported original research drugs
    EU listing

    1.  
    Various oil and fat emulsion injections (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    500 ml
    Fresenius Kabi AB
    No imported original research drugs
    EU listing

    1.  
    Various oil and fat emulsion injections (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    250 ml
    Fresenius Kabi AB
    No imported original research drugs
    EU listing

    1.  
    Various oil and fat emulsion injections (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    100 ml
    Fresenius Kabi AB
    No imported original research drugs
    EU listing

    1.  
    Aminolevulinic acid hexyl ester hydrochloride and special solvent for bladder perfusion
    Hexaminolevulinate Hydrochloride Powder And Solvent For Intravesical Solution/Hexvix
    85mg
    Ipsen Pharma Gmbh
    No imported original research drugs
    EU listing

    1.  
    Diquafosol Sodium Eye Drops
    Diquafosol Sodium Eye Drops/Diquas
    3% (5ml:150mg)
    Santen Pharmaceutical Co.
    , Ltd.
    No imported original research drugs
    Listed in Japan

    1.  
    Sucralfate Oral Suspension
    Sucralfate Oral Suspension /Ulcerlmin
    10ml:1g(10%)
    Fuji Chemical Industry Co.
    , Ltd.
    Unimported original research drugs
    Listed in Japan

    1.  
    Sodium picosulfate oral solution
    Sodium Picosulfate Oral Solution/Laxoberon
    7.
    5mg/ml
    Sanofi
    No imported original research drugs
    Listed in Japan

    1.  
    Clobazam tablets
    Clobazam Tablets/Frisium
    10mg
    Aventis Pharma Ltd
    No imported original research drugs
    UK listed
    10-86
    Riluzole tablets
    Riluzole Tablets/RILUTEK
    50mg
    Aventis Pharma SA /Sanofi Mature IP
    Original research import
    The license holder has changed, and the license holder Sanofi Mature IP is added after the change
    10-106
    Midazolam Maleate Tablets
    Midazolam Maleate Tablets/Dormicum
    15mg (calculated as C18H13C1FN3)
    Roche Pharma (Schweiz) Ltd.
    /Roche Pharma (Schweiz) AG/CHEPLAPHARM Arzneimittel GmbH
    Original research import
    The license holder has changed and the license holder Roche Pharma (Schweiz) AG/CHEPLAPHARM Arzneimittel GmbH has been added after the change.
    16-12
    Albendazole Tablets
    Albendazole Tablets/Shi Ke Chang Chong Qing
    0.
    2g
    Sino-U.
    S.
    Tianjin SmithKline Pharmaceutical Co.
    , Ltd.
    Original research and localized varieties
    The errata of the licensee is Sino-U.
    S.
    Tianjin SmithKline Pharmaceutical Co.
    , Ltd.
    21-40
    Concentrated zoledronic acid solution for injection
    Zoledronic Acid Concentrated Solution for Injection/Zometa
    5ml: 4mg
    Novartis Pharma Schweiz AG /Future Health Pharma GmbH
    Original drugs marketed in China
    The license holder has changed, and the license holder Future Health Pharma GmbH will be added after the change.
    Remark
    1.
    The generic names and dosage forms of the varieties listed in the catalogue that have not yet been marketed in China shall be subject to those approved by the Pharmacopoeia Commission
    .
    2.
    After the publication of the reference preparation catalogue, the varieties that have not been officially released will be subject to special research and will be released separately based on the research results
    .
    3.
    The reference preparations marketed in the EU include the same drugs marketed in the UK
    .
    4.
    Selecting non-imported reference preparations to carry out generic drug research should not only meet its quality requirements, but also meet the requirements of the current version of the Chinese Pharmacopoeia and related guidelines
    .
     
    　　State Food and Drug Administration
     
    　　July 22, 2021
    　　Medical Net, July 26, has been reviewed and determined by the Expert Committee of the Quality and Efficacy Consistency Evaluation of Generic Drugs of the National Medical Products Administration
    .
    The catalogue of generic drug reference preparations (the 43rd batch) is now released .
     
    　　Hereby inform
    .
     
    　　Attachment: List of generic reference preparations (forty-third batch)
    Serial number
    Generic name of the drug
    English name/trade name
    Specification
    Licensee
    Remark 1
    Remark 2

    1.  
    Tacrolimus injection
    Tacrolimus injection
    1ml:5mg
    Astellas Pharma Co.
    Ltd.
    Original drugs marketed in China
    Original research import

    1.  
    Rifaximin Tablets
    Rifaximin Tabiels/ Xifaxan
    200mg
    Alfasigma SpA
    Original drugs marketed in China
    Original research import

    1.  
    Fat emulsion (20%) / amino acid (15) / glucose (30%) injection
    Lipid Emulsion (20%)/Amino Acids (15) and Glucose (30%) Injection/ Clinomel
    1000ml[fat emulsion injection (20%) 200ml; compound amino acid (8.
    5%, 15AA) injection 400ml; glucose injection (30%) 400ml]
    BAXTER SAS
    Original drugs marketed in China
    Original research import

    1.  
    Fat emulsion (20%) / amino acid (15) / glucose (30%) injection
    Lipid Emulsion (20%)/Amino Acids (15) and Glucose (30%) Injection/ Clinomel
    1500ml[fat emulsion injection (20%) 300ml; compound amino acid (8.
    5%, 15AA) injection 600ml; glucose injection (30%) 600ml]
    BAXTER SAS
    Original drugs marketed in China
    Original research import

    1.  
    Levothyroxine Sodium Oral Solution
    Levothyroxine Sodium Oral Solution /Thyquidity
    100µg/5ml
    EMP LEVO US BV
    No imported original research drugs
    American Orange Book

    1.  
    Clobazam oral suspension
    Clobazam Oral Suspension/ Onfi
    2.
    5mg/ml (120ml:300mg)
    Lundbeck Pharmaceuticals LLC
    No imported original research drugs
    American Orange Book

    1.  
    Estradiol tablets
    Estradiol Tablets
    1mg
    Barr Laboratories Inc
    Internationally recognized drugs of the same kind
    American Orange Book

    1.  
    Proparacaine Hydrochloride Eye Drops
    0.
    5%（15ml）
    Akorn Inc

    1.  
    Famotidine and Sodium Chloride Injection
    0.
    4mg/ml
    Baxter Healthcare Corpration

    1.  
    Calcitriol Oral Solution
    15ml:15μg
    Validus Pharmaceuticals LLC

    1.  
    Colchicine Oral Solution/ Gloperba
    0.
    6mg/5ml
    Avion Pharmaceuticals LLC

    1.  
    Sildenafil Sitrate For Oral Suspension
    10mg/mL
    Upjohn EESV

    1.  
    Methotrexate Disodium Solution For Injection In Pre-Filled Syringe/Metoject、Metex
    50mg/ml
    medac Gesellschaft für klinische Spezialpräparate mbH

    1.  
    Enzalutamide Tablets
    80mg
    アステラス

    1.  
    Ketoprofen Cataplasms
    30mg,10cm×14cm

    1.  
    Tizanidine Hydrochloride Granules / Ternelin
    0.
    2%（1g2mg）
    サンファーマ

    1.  
    Domiphen bromide Buccal Tablets/Oradol
    0.
    5mg
    テバファーマ

    1.  
    Sodium Picosulfate Tablets/ラキソベロン2.
    5mg
    2.
    5mg
    ファーマ

    1.  
    Ketoconazole Cream
    2%, 30g/piece
    Janssen-Cilag Ltd
    No imported original research drugs
    UK listed

    1.  
    Levosimendan Injection
    Levosimendan Injection
    5ml:12.
    5mg
    Orion Corporation
    Original drugs marketed in China
    Original research import

    1.  
    Esmolol Hydrochloride and Sodium Chloride Injection
    Esmolol Hydrochloride and Sodium Chloride Injection
    100ml: 2g esmolol hydrochloride and 0.
    41g sodium chloride
    Shanghai Baxter Medical Products Co.
    , Ltd.
    Drugs produced in China by foreign original research companies that have been reviewed and determined
    Original research real estate

    1.  
    Gadolinium meglumine injection
    Gadobenate Dimeglumine Injection
    10.
    58GM/20ML (529MG/ML)
    Bracco Diagnostics Inc.
    No imported original research drugs
    American Orange Book

    1.  
    Dexrazoxane for injection
    Dexrazoxane for Injection/Totect
    500mg
    Clinigen, Inc.
    No imported original research drugs
    American Orange Book

    1.  
    Lenalidomide capsules
    Lenalidomide Capsules/Revlimid
    10mg
    Celgene Corporation
    No imported original research drugs
    American Orange Book

    1.  
    Lenalidomide capsules
    Lenalidomide Capsules/Revlimid
    25mg
    Celgene Corporation
    No imported original research drugs
    American Orange Book

    1.  
    Efavirenz Lamivudine Tenofovir Tablets
    Efavirenz Lamivudine and tenofovir Disoproxil Fumarate Tablets/Symfi
    Each tablet contains efavirenz 600mg, lamivudine 300mg and tenofovir disoproxil fumarate 300mg
    Mylan Laboratories Ltd
    No imported original research drugs
    American Orange Book

    1.  
    Potassium chloride oral solution
    Potassium Chloride Oral Solution
    20mEq/15ml
    (473ml)
    Genus Life Sciences Inc
    No imported original research drugs
    American Orange Book

    1.  
    Ramipril tablets
    Ramipril Tablets/
    Tritace
    2.
    5mg
    Sanofi Belgium
    No imported original research drugs
    EU listing

    1.  
    Ramipril tablets
    Ramipril Tablets/
    Tritace
    5mg
    Sanofi Belgium
    No imported original research drugs
    EU listing

    1.  
    Amorolfine Hydrochloride Liniment
    Amorolfine Hydrochloride Liniment
    0.
    05%
    Galderma International
    No imported original research drugs
    EU listing

    1.  
    Various oil and fat emulsion injections (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    1000 ml
    Fresenius Kabi AB
    No imported original research drugs
    EU listing

    1.  
    Various oil and fat emulsion injections (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    500 ml
    Fresenius Kabi AB
    No imported original research drugs
    EU listing

    1.  
    Various oil and fat emulsion injections (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    250 ml
    Fresenius Kabi AB
    No imported original research drugs
    EU listing

    1.  
    Various oil and fat emulsion injections (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    100 ml
    Fresenius Kabi AB
    No imported original research drugs
    EU listing

    1.  
    Aminolevulinic acid hexyl ester hydrochloride and special solvent for bladder perfusion
    Hexaminolevulinate Hydrochloride Powder And Solvent For Intravesical Solution/Hexvix
    85mg
    Ipsen Pharma Gmbh
    No imported original research drugs
    EU listing

    1.  
    Diquafosol Sodium Eye Drops
    Diquafosol Sodium Eye Drops/Diquas
    3% (5ml:150mg)
    Santen Pharmaceutical Co.
    , Ltd.
    No imported original research drugs
    Listed in Japan

    1.  
    Sucralfate Oral Suspension
    Sucralfate Oral Suspension /Ulcerlmin
    10ml:1g(10%)
    Fuji Chemical Industry Co.
    , Ltd.
    Unimported original research drugs
    Listed in Japan

    1.  
    Sodium picosulfate oral solution
    Sodium Picosulfate Oral Solution/Laxoberon
    7.
    5mg/ml
    Sanofi
    No imported original research drugs
    Listed in Japan

    1.  
    Clobazam tablets
    Clobazam Tablets/Frisium
    10mg
    Aventis Pharma Ltd
    No imported original research drugs
    UK listed
    10-86
    Riluzole tablets
    Riluzole Tablets/RILUTEK
    50mg
    Aventis Pharma SA /Sanofi Mature IP
    Original research import
    The license holder has changed, and the license holder Sanofi Mature IP is added after the change
    10-106
    Midazolam Maleate Tablets
    Midazolam Maleate Tablets/Dormicum
    15mg (calculated as C18H13C1FN3)
    Roche Pharma (Schweiz) Ltd.
    /Roche Pharma (Schweiz) AG/CHEPLAPHARM Arzneimittel GmbH
    Original research import
    The license holder has changed and the license holder Roche Pharma (Schweiz) AG/CHEPLAPHARM Arzneimittel GmbH has been added after the change.
    16-12
    Albendazole Tablets
    Albendazole Tablets/Shi Ke Chang Chong Qing
    0.
    2g
    Sino-U.
    S.
    Tianjin SmithKline Pharmaceutical Co.
    , Ltd.
    Original research and localized varieties
    The errata of the licensee is Sino-U.
    S.
    Tianjin SmithKline Pharmaceutical Co.
    , Ltd.
    21-40
    Concentrated zoledronic acid solution for injection
    Zoledronic Acid Concentrated Solution for Injection/Zometa
    5ml: 4mg
    Novartis Pharma Schweiz AG /Future Health Pharma GmbH
    Original drugs marketed in China
    The license holder has changed, and the license holder Future Health Pharma GmbH will be added after the change.
    Remark
    1.
    The generic names and dosage forms of the varieties listed in the catalogue that have not yet been marketed in China shall be subject to those approved by the Pharmacopoeia Commission
    .
    2.
    After the publication of the reference preparation catalogue, the varieties that have not been officially released will be subject to special research and will be released separately based on the research results
    .
    3.
    The reference preparations marketed in the EU include the same drugs marketed in the UK
    .
    4.
    Selecting non-imported reference preparations to carry out generic drug research should not only meet its quality requirements, but also meet the requirements of the current version of the Chinese Pharmacopoeia and related guidelines
    .
     
    Serial number
    Generic name of the drug
    English name/trade name
    Specification
    Licensee
    Remark 1
    Remark 2

    1.  
    Tacrolimus injection
    Tacrolimus injection
    1ml:5mg
    Astellas Pharma Co.
    Ltd.
    Original drugs marketed in China
    Original research import

    1.  
    Rifaximin Tablets
    Rifaximin Tabiels/ Xifaxan
    200mg
    Alfasigma SpA
    Original drugs marketed in China
    Original research import

    1.  
    Fat emulsion (20%) / amino acid (15) / glucose (30%) injection
    Lipid Emulsion (20%)/Amino Acids (15) and Glucose (30%) Injection/ Clinomel
    1000ml[fat emulsion injection (20%) 200ml; compound amino acid (8.
    5%, 15AA) injection 400ml; glucose injection (30%) 400ml]
    BAXTER SAS
    Original drugs marketed in China
    Original research import

    1.  
    Fat emulsion (20%) / amino acid (15) / glucose (30%) injection
    Lipid Emulsion (20%)/Amino Acids (15) and Glucose (30%) Injection/ Clinomel
    1500ml[fat emulsion injection (20%) 300ml; compound amino acid (8.
    5%, 15AA) injection 600ml; glucose injection (30%) 600ml]
    BAXTER SAS
    Original drugs marketed in China
    Original research import

    1.  
    Levothyroxine Sodium Oral Solution
    Levothyroxine Sodium Oral Solution /Thyquidity
    100µg/5ml
    EMP LEVO US BV

    1.  
    Clobazam Oral Suspension/ Onfi
    2.
    5mg/ml（120ml:300mg）
    Lundbeck Pharmaceuticals LLC

    1.  
    Estradiol Tablets
    1mg
    Barr Laboratories Inc

    1.  
    Proparacaine Hydrochloride Eye Drops
    0.
    5%（15ml）
    Akorn Inc

    1.  
    Famotidine and Sodium Chloride Injection
    0.
    4mg/ml
    Baxter Healthcare Corpration

    1.  
    Calcitriol Oral Solution
    15ml:15μg
    Validus Pharmaceuticals LLC

    1.  
    Colchicine Oral Solution/ Gloperba
    0.
    6mg/5ml
    Avion Pharmaceuticals LLC

    1.  
    Sildenafil Sitrate For Oral Suspension
    10mg/mL
    Upjohn EESV

    1.  
    Methotrexate Disodium Solution For Injection In Pre-Filled Syringe/Metoject、Metex
    50mg/ml
    medac Gesellschaft für klinische Spezialpräparate mbH

    1.  
    Enzalutamide Tablets
    80mg
    アステラス

    1.  
    Ketoprofen Cataplasms
    30mg,10cm×14cm

    1.  
    Tizanidine Hydrochloride Granules / Ternelin
    0.
    2% (1g granules containing 2mg tizanidine)
    Sunfame Co.
    , Ltd.
    No imported original research drugs
    Listed in Japan

    1.  
    Domifene lozenges
    Domiphen bromide Buccal Tablets/Oradol
    0.
    5mg
    Takeda Technology Co.
    , Ltd.
    No imported original research drugs
    Listed in Japan

    1.  
    Sodium picosulfate tablets
    Sodium Picosulfate Tablets/ ラキソベロン Tablet 2.
    5mg
    2.
    5mg
    Teijin Fame Co.
    , Ltd.
    No imported original research drugs
    Listed in Japan

    1.  
    Ketoconazole Cream
    Ketoconazole Cream
    2%, 30g/piece
    Janssen-Cilag Ltd
    No imported original research drugs
    UK listed

    1.  
    Levosimendan Injection
    Levosimendan Injection
    5ml:12.
    5mg
    Orion Corporation
    Original drugs marketed in China
    Original research import

    1.  
    Esmolol Hydrochloride and Sodium Chloride Injection
    Esmolol Hydrochloride and Sodium Chloride Injection
    100ml: 2g esmolol hydrochloride and 0.
    41g sodium chloride
    Shanghai Baxter Medical Products Co.
    , Ltd.
    Drugs produced in China by foreign original research companies that have been reviewed and determined
    Original research real estate

    1.  
    Gadolinium meglumine injection
    Gadobenate Dimeglumine Injection
    10.
    58GM/20ML (529MG/ML)
    Bracco Diagnostics Inc.
    No imported original research drugs
    American Orange Book

    1.  
    Dexrazoxane for injection
    Dexrazoxane for Injection/Totect
    500mg
    Clinigen, Inc.
    No imported original research drugs
    American Orange Book

    1.  
    Lenalidomide capsules
    Lenalidomide Capsules/Revlimid
    10mg
    Celgene Corporation
    No imported original research drugs
    American Orange Book

    1.  
    Lenalidomide capsules
    Lenalidomide Capsules/Revlimid
    25mg
    Celgene Corporation
    No imported original research drugs
    American Orange Book

    1.  
    Efavirenz Lamivudine Tenofovir Tablets
    Efavirenz Lamivudine and tenofovir Disoproxil Fumarate Tablets/Symfi
    Each tablet contains efavirenz 600mg, lamivudine 300mg and tenofovir disoproxil fumarate 300mg
    Mylan Laboratories Ltd
    No imported original research drugs
    American Orange Book

    1.  
    Potassium chloride oral solution
    Potassium Chloride Oral Solution
    20mEq/15ml
    (473ml)
    Genus Life Sciences Inc
    No imported original research drugs
    American Orange Book

    1.  
    Ramipril tablets
    Ramipril Tablets/
    Tritace
    2.
    5mg
    Sanofi Belgium
    No imported original research drugs
    EU listing

    1.  
    Ramipril tablets
    Ramipril Tablets/
    Tritace
    5mg
    Sanofi Belgium
    No imported original research drugs
    EU listing

    1.  
    Amorolfine Hydrochloride Liniment
    Amorolfine Hydrochloride Liniment
    0.
    05%
    Galderma International
    No imported original research drugs
    EU listing

    1.  
    Various oil and fat emulsion injections (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    1000 ml
    Fresenius Kabi AB
    No imported original research drugs
    EU listing

    1.  
    Various oil and fat emulsion injections (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    500 ml
    Fresenius Kabi AB
    No imported original research drugs
    EU listing

    1.  
    Various oil and fat emulsion injections (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    250 ml
    Fresenius Kabi AB
    No imported original research drugs
    EU listing

    1.  
    Various oil and fat emulsion injections (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    100 ml
    Fresenius Kabi AB
    No imported original research drugs
    EU listing

    1.  
    Aminolevulinic acid hexyl ester hydrochloride and special solvent for bladder perfusion
    Hexaminolevulinate Hydrochloride Powder And Solvent For Intravesical Solution/Hexvix
    85mg
    Ipsen Pharma Gmbh
    No imported original research drugs
    EU listing

    1.  
    Diquafosol Sodium Eye Drops
    Diquafosol Sodium Eye Drops/Diquas
    3% (5ml:150mg)
    Santen Pharmaceutical Co.
    , Ltd.
    No imported original research drugs
    Listed in Japan

    1.  
    Sucralfate Oral Suspension
    Sucralfate Oral Suspension /Ulcerlmin
    10ml:1g(10%)
    Fuji Chemical Industry Co.
    , Ltd.
    Unimported original research drugs
    Listed in Japan

    1.  
    Sodium picosulfate oral solution
    Sodium Picosulfate Oral Solution/Laxoberon
    7.
    5mg/ml
    Sanofi
    No imported original research drugs
    Listed in Japan

    1.  
    Clobazam tablets
    Clobazam Tablets/Frisium
    10mg
    Aventis Pharma Ltd
    No imported original research drugs
    UK listed
    10-86
    Riluzole tablets
    Riluzole Tablets/RILUTEK
    50mg
    Aventis Pharma SA /Sanofi Mature IP
    Original research import
    The license holder has changed, and the license holder Sanofi Mature IP is added after the change
    10-106
    Midazolam Maleate Tablets
    Midazolam Maleate Tablets/Dormicum
    15mg (calculated as C18H13C1FN3)
    Roche Pharma (Schweiz) Ltd.
    /Roche Pharma (Schweiz) AG/CHEPLAPHARM Arzneimittel GmbH
    Original research import
    The license holder has changed and the license holder Roche Pharma (Schweiz) AG/CHEPLAPHARM Arzneimittel GmbH has been added after the change.
    16-12
    Albendazole Tablets
    Albendazole Tablets/Shi Ke Chang Chong Qing
    0.
    2g
    Sino-U.
    S.
    Tianjin SmithKline Pharmaceutical Co.
    , Ltd.
    Original research and localized varieties
    The errata of the licensee is Sino-U.
    S.
    Tianjin SmithKline Pharmaceutical Co.
    , Ltd.
    21-40
    Concentrated zoledronic acid solution for injection
    Zoledronic Acid Concentrated Solution for Injection/Zometa
    5ml: 4mg
    Novartis Pharma Schweiz AG /Future Health Pharma GmbH
    Original drugs marketed in China
    The license holder has changed, and the license holder Future Health Pharma GmbH will be added after the change.
    Remark
    1.
    The generic names and dosage forms of the varieties listed in the catalogue that have not yet been marketed in China shall be subject to those approved by the Pharmacopoeia Commission
    .
    2.
    After the publication of the reference preparation catalogue, the varieties that have not been officially released will be subject to special research and will be released separately based on the research results
    .
    3.
    The reference preparations marketed in the EU include the same drugs marketed in the UK
    .
    4.
    Selecting non-imported reference preparations to carry out generic drug research should not only meet its quality requirements, but also meet the requirements of the current version of the Chinese Pharmacopoeia and related guidelines
    .

    Serial number

    Generic name of the drug

    English name/trade name

    Specification

    Licensee

    Remark 1

    Remark 2

    Serial number

    Generic name of the drug

    English name/trade name

    Specification

    Licensee

    Remark 1

    Remark 2

    Serial number
    Serial number
    Generic name of the drug
    Generic name of the drug
    English name/trade name
    English name/trade name
    Specification
    Specification
    Licensee
    Licensee
    Remark 1
    Remark 1
    Remark 2
    Remark 2


    1.  

    Tacrolimus injection

    Tacrolimus injection

    1ml:5mg

    Astellas Pharma Co.
    Ltd.

    Original drugs marketed in China

    Original research import


    1.  

    Rifaximin Tablets

    Rifaximin Tabiels/ Xifaxan

    200mg

    Alfasigma SpA

    Original drugs marketed in China

    Original research import


    1.  

    Fat emulsion (20%) / amino acid (15) / glucose (30%) injection

    Lipid Emulsion (20%)/Amino Acids (15) and Glucose (30%) Injection/ Clinomel

    1000ml[fat emulsion injection (20%) 200ml; compound amino acid (8.
    5%, 15AA) injection 400ml; glucose injection (30%) 400ml]

    BAXTER SAS

    Original drugs marketed in China

    Original research import


    1.  

    Fat emulsion (20%) / amino acid (15) / glucose (30%) injection

    Lipid Emulsion (20%)/Amino Acids (15) and Glucose (30%) Injection/ Clinomel

    1500ml[fat emulsion injection (20%) 300ml; compound amino acid (8.
    5%, 15AA) injection 600ml; glucose injection (30%) 600ml]

    BAXTER SAS

    Original drugs marketed in China

    Original research import


    1.  

    Levothyroxine Sodium Oral Solution

    Levothyroxine Sodium Oral Solution /Thyquidity

    100µg/5ml

    EMP LEVO US BV

    No imported original research drugs

    American Orange Book


    1.  

    Clobazam oral suspension

    Clobazam Oral Suspension/ Onfi

    2.
    5mg/ml (120ml:300mg)

    Lundbeck Pharmaceuticals LLC

    No imported original research drugs

    American Orange Book


    1.  

    Estradiol tablets

    Estradiol Tablets

    1mg

    Barr Laboratories Inc

    Internationally recognized drugs of the same kind

    American Orange Book


    1.  

    Proparacaine Hydrochloride Eye Drops

    Proparacaine Hydrochloride Eye Drops

    0.
    5% (15ml)

    Akorn Inc

    Internationally recognized drugs of the same kind

    American Orange Book


    1.  

    Famotidine Sodium Chloride Injection

    Famotidine and Sodium Chloride Injection

    0.
    4mg/ml

    Baxter Healthcare Corpration

    Internationally recognized drugs of the same kind

    American Orange Book


    1.  

    Calcitriol oral solution

    Calcitriol Oral Solution

    15ml:15μg

    Validus Pharmaceuticals LLC

    No imported original research drugs

    American Orange Book


    1.  

    Colchicine Oral Solution

    Colchicine Oral Solution/ Gloperba

    0.
    6mg/5ml

    Avion Pharmaceuticals LLC

    No imported original research drugs

    American Orange Book


    1.  

    Sildenafil Citrate Dry Suspension

    Sildenafil Sitrate For Oral Suspension

    10mg/mL

    Upjohn EESV

    No imported original research drugs

    EU listing


    1.  

    Pre-filled methotrexate injection

    Methotrexate Disodium Solution For Injection In Pre-Filled Syringe/Metoject, Metex

    50mg/ml

    medac Gesellschaft für klinische Spezialpräparate mbH

    No imported original research drugs

    EU listing


    1.  

    Enzalutamide Tablets

    Enzalutamide Tablets

    80mg

    Asteras Pharmaceutical Co.
    , Ltd.

    No imported original research drugs

    Listed in Japan


    1.  

    Ketoprofen Gel Patch

    Ketoprofen Cataplasms

    30mg,10cm×14cm

    Hisamitsu Pharmaceutical Co.
    , Ltd.

    No imported original research drugs

    Listed in Japan


    1.  

    Tizanidine Hydrochloride Granules

    Tizanidine Hydrochloride Granules / Ternelin

    0.
    2% (1g granules containing 2mg tizanidine)

    Sunfame Co.
    , Ltd.

    No imported original research drugs

    Listed in Japan


    1.  

    Domifene lozenges

    Domiphen bromide Buccal Tablets/Oradol

    0.
    5mg

    Takeda Technology Co.
    , Ltd.

    No imported original research drugs

    Listed in Japan


    1.  

    Sodium picosulfate tablets

    Sodium Picosulfate Tablets/ ラキソベロン Tablet 2.
    5mg

    2.
    5mg

    Teijin Fame Co.
    , Ltd.

    No imported original research drugs

    Listed in Japan


    1.  

    Ketoconazole Cream

    Ketoconazole Cream

    2%, 30g/piece

    Janssen-Cilag Ltd

    No imported original research drugs

    UK listed


    1.  

    Levosimendan Injection

    Levosimendan Injection

    5ml:12.
    5mg

    Orion Corporation

    Original drugs marketed in China

    Original research import


    1.  

    Esmolol Hydrochloride and Sodium Chloride Injection

    Esmolol Hydrochloride and Sodium Chloride Injection

    100ml: 2g esmolol hydrochloride and 0.
    41g sodium chloride

    Shanghai Baxter Medical Products Co.
    , Ltd.

    Drugs produced in China by foreign original research companies that have been reviewed and determined

    Original research real estate


    1.  

    Gadolinium meglumine injection

    Gadobenate Dimeglumine Injection

    10.
    58GM/20ML (529MG/ML)

    Bracco Diagnostics Inc.

    No imported original research drugs

    American Orange Book


    1.  

    Dexrazoxane for injection

    Dexrazoxane for Injection/Totect

    500mg

    Clinigen, Inc.

    No imported original research drugs

    American Orange Book


    1.  

    Lenalidomide capsules

    Lenalidomide Capsules/Revlimid

    10mg

    Celgene Corporation

    No imported original research drugs

    American Orange Book


    1.  

    Lenalidomide capsules

    Lenalidomide Capsules/Revlimid

    25mg

    Celgene Corporation

    No imported original research drugs

    American Orange Book


    1.  

    Efavirenz Lamivudine Tenofovir Tablets

    Efavirenz Lamivudine and tenofovir Disoproxil Fumarate Tablets/Symfi

    Each tablet contains efavirenz 600mg, lamivudine 300mg and tenofovir disoproxil fumarate 300mg

    Mylan Laboratories Ltd

    No imported original research drugs

    American Orange Book


    1.  

    Potassium chloride oral solution

    Potassium Chloride Oral Solution

    20mEq/15ml
    (473ml)

    Genus Life Sciences Inc

    No imported original research drugs

    American Orange Book


    1.  

    Ramipril tablets

    Ramipril Tablets/
    Tritace

    2.
    5mg

    Sanofi Belgium

    No imported original research drugs

    EU listing


    1.  

    Ramipril tablets

    Ramipril Tablets/
    Tritace

    5mg

    Sanofi Belgium

    No imported original research drugs

    EU listing


    1.  

    Amorolfine Hydrochloride Liniment

    Amorolfine Hydrochloride Liniment

    0.
    05%

    Galderma International

    No imported original research drugs

    EU listing


    1.  

    Various oil and fat emulsion injections (C6～24)

    Multi-Oil Fat Emulsion Injection (C6～24)

    1000 ml

    Fresenius Kabi AB

    No imported original research drugs

    EU listing


    1.  

    Various oil and fat emulsion injections (C6～24)

    Multi-Oil Fat Emulsion Injection (C6～24)

    500 ml

    Fresenius Kabi AB

    No imported original research drugs

    EU listing


    1.  

    Various oil and fat emulsion injections (C6～24)

    Multi-Oil Fat Emulsion Injection (C6～24)

    250 ml

    Fresenius Kabi AB

    No imported original research drugs

    EU listing


    1.  

    Various oil and fat emulsion injections (C6～24)

    Multi-Oil Fat Emulsion Injection (C6～24)

    100 ml

    Fresenius Kabi AB

    No imported original research drugs

    EU listing


    1.  

    Aminolevulinic acid hexyl ester hydrochloride and special solvent for bladder perfusion

    Hexaminolevulinate Hydrochloride Powder And Solvent For Intravesical Solution/Hexvix

    85mg

    Ipsen Pharma Gmbh

    No imported original research drugs

    EU listing


    1.  

    Diquafosol Sodium Eye Drops

    Diquafosol Sodium Eye Drops/Diquas

    3% (5ml:150mg)

    Santen Pharmaceutical Co.
    , Ltd.

    No imported original research drugs

    Listed in Japan


    1.  

    Sucralfate Oral Suspension

    Sucralfate Oral Suspension /Ulcerlmin

    10ml:1g(10%)

    Fuji Chemical Industry Co.
    , Ltd.

    Unimported original research drugs

    Listed in Japan


    1.  

    Sodium picosulfate oral solution

    Sodium Picosulfate Oral Solution/Laxoberon

    7.
    5mg/ml

    Sanofi

    No imported original research drugs

    Listed in Japan


    1.  

    Clobazam tablets

    Clobazam Tablets/Frisium

    10mg

    Aventis Pharma Ltd

    No imported original research drugs

    UK listed

    10-86

    Riluzole tablets

    Riluzole Tablets/RILUTEK

    50mg

    Aventis Pharma SA /Sanofi Mature IP

    Original research import

    The license holder has changed, and the license holder Sanofi Mature IP is added after the change

    10-106

    Midazolam Maleate Tablets

    Midazolam Maleate Tablets/Dormicum

    15mg (calculated as C18H13C1FN3)

    Roche Pharma (Schweiz) Ltd.
    /Roche Pharma (Schweiz) AG/CHEPLAPHARM Arzneimittel GmbH

    Original research import

    The license holder has changed and the license holder Roche Pharma (Schweiz) AG/CHEPLAPHARM Arzneimittel GmbH has been added after the change.

    16-12

    Albendazole Tablets

    Albendazole Tablets/Shi Ke Chang Chong Qing

    0.
    2g

    Sino-U.
    S.
    Tianjin SmithKline Pharmaceutical Co.
    , Ltd.

    Original research and localized varieties

    The errata of the licensee is Sino-U.
    S.
    Tianjin SmithKline Pharmaceutical Co.
    , Ltd.

    21-40

    Concentrated zoledronic acid solution for injection

    Zoledronic Acid Concentrated Solution for Injection/Zometa

    5ml: 4mg

    Novartis Pharma Schweiz AG /Future Health Pharma GmbH

    Original drugs marketed in China

    The license holder has changed, and the license holder Future Health Pharma GmbH will be added after the change.

    Remark

    1.
    The generic names and dosage forms of the varieties listed in the catalogue that have not yet been marketed in China shall be subject to those approved by the Pharmacopoeia Commission
    .
    2.
    After the publication of the reference preparation catalogue, the varieties that have not been officially released will be subject to special research and will be released separately based on the research results
    .
    3.
    The reference preparations marketed in the EU include the same drugs marketed in the UK
    .
    4.
    Selecting non-imported reference preparations to carry out generic drug research should not only meet its quality requirements, but also meet the requirements of the current version of the Chinese Pharmacopoeia and related guidelines
    .


    1.  

    Tacrolimus injection

    Tacrolimus injection

    1ml:5mg

    Astellas Pharma Co.
    Ltd.

    Original drugs marketed in China

    Original research import


    1.  

    1.  
  •  
    • Tacrolimus injection
    Tacrolimus injection
    Tacrolimus injection
    Tacrolimus injection
    1ml:5mg
    1ml:5mg
    Astellas Pharma Co.
    Ltd.
    Astellas Pharma Co.
    Ltd.
    Original drugs marketed in China
    Original drugs marketed in China
    Original research import
    Original research import


    1.  

    Rifaximin Tablets

    Rifaximin Tabiels/ Xifaxan

    200mg

    Alfasigma SpA

    Original drugs marketed in China

    Original research import


    1.  

    1.  
  •  
    • Rifaximin Tablets
    Rifaximin Tablets
    Rifaximin Tabiels/ Xifaxan
    Rifaximin Tabiels/ Xifaxan
    200mg
    200mg
    Alfasigma SpA
    Alfasigma SpA
    Original drugs marketed in China
    Original drugs marketed in China
    Original research import
    Original research import


    1.  

    Fat emulsion (20%) / amino acid (15) / glucose (30%) injection

    Lipid Emulsion (20%)/Amino Acids (15) and Glucose (30%) Injection/ Clinomel

    1000ml[fat emulsion injection (20%) 200ml; compound amino acid (8.
    5%, 15AA) injection 400ml; glucose injection (30%) 400ml]

    BAXTER SAS

    Original drugs marketed in China

    Original research import


    1.  

    1.  
  •  
    • Fat emulsion (20%) / amino acid (15) / glucose (30%) injection
    Fat emulsion (20%) / amino acid (15) / glucose (30%) injection
    Lipid Emulsion (20%)/Amino Acids (15) and Glucose (30%) Injection/ Clinomel
    Lipid Emulsion (20%)/Amino Acids (15) and Glucose (30%) Injection/ Clinomel
    1000ml[fat emulsion injection (20%) 200ml; compound amino acid (8.
    5%, 15AA) injection 400ml; glucose injection (30%) 400ml]
    1000ml[fat emulsion injection (20%) 200ml; compound amino acid (8.
    5%, 15AA) injection 400ml; glucose injection (30%) 400ml]
    BAXTER SAS
    BAXTER SAS
    Original drugs marketed in China
    Original drugs marketed in China
    Original research import
    Original research import


    1.  

    Fat emulsion (20%) / amino acid (15) / glucose (30%) injection

    Lipid Emulsion (20%)/Amino Acids (15) and Glucose (30%) Injection/ Clinomel

    1500ml[fat emulsion injection (20%) 300ml; compound amino acid (8.
    5%, 15AA) injection 600ml; glucose injection (30%) 600ml]

    BAXTER SAS

    Original drugs marketed in China

    Original research import


    1.  

    1.  
  •  
    • Fat emulsion (20%) / amino acid (15) / glucose (30%) injection
    Fat emulsion (20%) / amino acid (15) / glucose (30%) injection
    Lipid Emulsion (20%)/Amino Acids (15) and Glucose (30%) Injection/ Clinomel
    Lipid Emulsion (20%)/Amino Acids (15) and Glucose (30%) Injection/ Clinomel
    1500ml[fat emulsion injection (20%) 300ml; compound amino acid (8.
    5%, 15AA) injection 600ml; glucose injection (30%) 600ml]
    1500ml[fat emulsion injection (20%) 300ml; compound amino acid (8.
    5%, 15AA) injection 600ml; glucose injection (30%) 600ml]
    BAXTER SAS
    BAXTER SAS
    Original drugs marketed in China
    Original drugs marketed in China
    Original research import
    Original research import


    1.  

    Levothyroxine Sodium Oral Solution

    Levothyroxine Sodium Oral Solution /Thyquidity

    100µg/5ml

    EMP LEVO US BV

    No imported original research drugs

    American Orange Book


    1.  

    1.  
  •  
    • Levothyroxine Sodium Oral Solution
    Levothyroxine Sodium Oral Solution
    Levothyroxine Sodium Oral Solution /Thyquidity
    Levothyroxine Sodium Oral Solution /Thyquidity
    100µg/5ml
    100µg/5ml
    EMP LEVO US BV
    EMP LEVO US BV
    No imported original research drugs
    No imported original research drugs
    American Orange Book
    American Orange Book


    1.  

    Clobazam oral suspension

    Clobazam Oral Suspension/ Onfi

    2.
    5mg/ml (120ml:300mg)

    Lundbeck Pharmaceuticals LLC

    No imported original research drugs

    American Orange Book


    1.  

    1.  
  •  
    • Clobazam oral suspension
    Clobazam oral suspension
    Clobazam Oral Suspension/ Onfi
    Clobazam Oral Suspension/ Onfi
    2.
    5mg/ml (120ml:300mg)
    2.
    5mg/ml (120ml:300mg)
    Lundbeck Pharmaceuticals LLC
    Lundbeck Pharmaceuticals LLC
    No imported original research drugs
    No imported original research drugs
    American Orange Book
    American Orange Book


    1.  

    Estradiol tablets

    Estradiol Tablets

    1mg

    Barr Laboratories Inc

    Internationally recognized drugs of the same kind

    American Orange Book


    1.  

    1.  
  •  
    • Estradiol tablets
    Estradiol tablets
    Estradiol Tablets
    Estradiol Tablets
    1mg
    1mg
    Barr Laboratories Inc
    Barr Laboratories Inc
    Internationally recognized drugs of the same kind
    Internationally recognized drugs of the same kind
    American Orange Book
    American Orange Book


    1.  

    Proparacaine Hydrochloride Eye Drops

    Proparacaine Hydrochloride Eye Drops

    0.
    5% (15ml)

    Akorn Inc

    Internationally recognized drugs of the same kind

    American Orange Book


    1.  

    1.  
  •  
    • Proparacaine Hydrochloride Eye Drops
    Proparacaine Hydrochloride Eye Drops
    Proparacaine Hydrochloride Eye Drops
    Proparacaine Hydrochloride Eye Drops
    0.
    5% (15ml)
    0.
    5% (15ml)
    Akorn Inc
    Akorn Inc
    Internationally recognized drugs of the same kind
    Internationally recognized drugs of the same kind
    American Orange Book
    American Orange Book


    1.  

    Famotidine Sodium Chloride Injection

    Famotidine and Sodium Chloride Injection

    0.
    4mg/ml

    Baxter Healthcare Corpration

    Internationally recognized drugs of the same kind

    American Orange Book


    1.  

    1.  
  •  
    • Famotidine Sodium Chloride Injection
    Famotidine Sodium Chloride Injection
    Famotidine and Sodium Chloride Injection
    Famotidine and Sodium Chloride Injection
    0.
    4mg/ml
    0.
    4mg/ml
    Baxter Healthcare Corpration
    Baxter Healthcare Corpration
    Internationally recognized drugs of the same kind
    Internationally recognized drugs of the same kind
    American Orange Book
    American Orange Book


    1.  

    Calcitriol oral solution

    Calcitriol Oral Solution

    15ml:15μg

    Validus Pharmaceuticals LLC

    No imported original research drugs

    American Orange Book


    1.  

    1.  
  •  
    • Calcitriol oral solution
    Calcitriol oral solution
    Calcitriol Oral Solution
    Calcitriol Oral Solution
    15ml:15μg
    15ml:15μg
    Validus Pharmaceuticals LLC
    Validus Pharmaceuticals LLC
    No imported original research drugs
    No imported original research drugs
    American Orange Book
    American Orange Book


    1.  

    Colchicine Oral Solution

    Colchicine Oral Solution/ Gloperba

    0.
    6mg/5ml

    Avion Pharmaceuticals LLC

    No imported original research drugs

    American Orange Book


    1.  

    1.  
  •  
    • Colchicine Oral Solution
    Colchicine Oral Solution
    Colchicine Oral Solution/ Gloperba
    Colchicine Oral Solution/ Gloperba
    0.
    6mg/5ml
    0.
    6mg/5ml
    Avion Pharmaceuticals LLC
    Avion Pharmaceuticals LLC
    No imported original research drugs
    No imported original research drugs
    American Orange Book
    American Orange Book


    1.  

    Sildenafil Citrate Dry Suspension

    Sildenafil Sitrate For Oral Suspension

    10mg/mL

    Upjohn EESV

    No imported original research drugs

    EU listing


    1.  

    1.  
  •  
    • Sildenafil Citrate Dry Suspension
    Sildenafil Citrate Dry Suspension
    Sildenafil Sitrate For Oral Suspension
    Sildenafil Sitrate For Oral Suspension
    10mg/mL
    10mg/mL
    Upjohn EESV
    Upjohn EESV
    No imported original research drugs
    No imported original research drugs
    EU listing
    EU listing


    1.  

    Pre-filled methotrexate injection

    Methotrexate Disodium Solution For Injection In Pre-Filled Syringe/Metoject, Metex

    50mg/ml

    medac Gesellschaft für klinische Spezialpräparate mbH

    No imported original research drugs

    EU listing


    1.  

    1.  
  •  
    • Pre-filled methotrexate injection
    Pre-filled methotrexate injection
    Methotrexate Disodium Solution For Injection In Pre-Filled Syringe/Metoject, Metex
    Methotrexate Disodium Solution For Injection In Pre-Filled Syringe/Metoject, Metex
    50mg/ml
    50mg/ml
    medac Gesellschaft für klinische Spezialpräparate mbH
    medac Gesellschaft für klinische Spezialpräparate mbH
    No imported original research drugs
    No imported original research drugs
    EU listing
    EU listing


    1.  

    Enzalutamide Tablets

    Enzalutamide Tablets

    80mg

    Asteras Pharmaceutical Co.
    , Ltd.

    No imported original research drugs

    Listed in Japan


    1.  

    1.  
  •  
    • Enzalutamide Tablets
    Enzalutamide Tablets
    Enzalutamide Tablets
    Enzalutamide Tablets
    80mg
    80mg
    Asteras Pharmaceutical Co.
    , Ltd.
    Asteras Pharmaceutical Co.
    , Ltd.
    No imported original research drugs
    No imported original research drugs
    Listed in Japan
    Listed in Japan


    1.  

    Ketoprofen Gel Patch

    Ketoprofen Cataplasms

    30mg,10cm×14cm

    Hisamitsu Pharmaceutical Co.
    , Ltd.

    No imported original research drugs

    Listed in Japan


    1.  

    1.  
  •  
    • Ketoprofen Gel Patch
    Ketoprofen Gel Patch
    Ketoprofen Cataplasms
    Ketoprofen Cataplasms
    30mg,10cm×14cm
    30mg,10cm×14cm
    Hisamitsu Pharmaceutical Co.
    , Ltd.
    Hisamitsu Pharmaceutical Co.
    , Ltd.
    No imported original research drugs
    No imported original research drugs
    Listed in Japan
    Listed in Japan


    1.  

    Tizanidine Hydrochloride Granules

    Tizanidine Hydrochloride Granules / Ternelin

    0.
    2% (1g granules containing 2mg tizanidine)

    Sunfame Co.
    , Ltd.

    No imported original research drugs

    Listed in Japan


    1.  

    1.  
  •  
    • Tizanidine Hydrochloride Granules
    Tizanidine Hydrochloride Granules
    Tizanidine Hydrochloride Granules / Ternelin
    Tizanidine Hydrochloride Granules / Ternelin
    0.
    2% (1g granules containing 2mg tizanidine)
    0.
    2% (1g granules containing 2mg tizanidine)
    Sunfame Co.
    , Ltd.
    Sunfame Co.
    , Ltd.
    No imported original research drugs
    No imported original research drugs
    Listed in Japan
    Listed in Japan


    1.  

    Domifene lozenges

    Domiphen bromide Buccal Tablets/Oradol

    0.
    5mg

    Takeda Technology Co.
    , Ltd.

    No imported original research drugs

    Listed in Japan


    1.  

    1.  
  •  
    • Domifene lozenges
    Domifene lozenges
    Domiphen bromide Buccal Tablets/Oradol
    Domiphen bromide Buccal Tablets/Oradol
    0.
    5mg
    0.
    5mg
    Takeda Technology Co.
    , Ltd.
    Takeda Technology Co.
    , Ltd.
    No imported original research drugs
    No imported original research drugs
    Listed in Japan
    Listed in Japan


    1.  

    Sodium picosulfate tablets

    Sodium Picosulfate Tablets/ ラキソベロン Tablet 2.
    5mg

    2.
    5mg

    Teijin Fame Co.
    , Ltd.

    No imported original research drugs

    Listed in Japan


    1.  

    1.  
  •  
    • Sodium picosulfate tablets
    Sodium picosulfate tablets
    Sodium Picosulfate Tablets/ ラキソベロン Tablet 2.
    5mg
    Sodium Picosulfate Tablets/ ラキソベロン Tablet 2.
    5mg
    2.
    5mg
    2.
    5mg
    Teijin Fame Co.
    , Ltd.
    Teijin Fame Co.
    , Ltd.
    No imported original research drugs
    No imported original research drugs
    Listed in Japan
    Listed in Japan


    1.  

    Ketoconazole Cream

    Ketoconazole Cream

    2%, 30g/piece

    Janssen-Cilag Ltd

    No imported original research drugs

    UK listed


    1.  

    1.  
  •  
    • Ketoconazole Cream
    Ketoconazole Cream
    Ketoconazole Cream
    Ketoconazole Cream
    2%, 30g/piece
    2%, 30g/piece
    Janssen-Cilag Ltd
    Janssen-Cilag Ltd
    No imported original research drugs
    No imported original research drugs
    UK listed
    UK listed


    1.  

    Levosimendan Injection

    Levosimendan Injection

    5ml:12.
    5mg

    Orion Corporation

    Original drugs marketed in China

    Original research import


    1.  

    1.  
  •  
    • Levosimendan Injection
    Levosimendan Injection
    Levosimendan Injection
    Levosimendan Injection
    5ml:12.
    5mg
    5ml:12.
    5mg
    Orion Corporation
    Orion Corporation
    Original drugs marketed in China
    Original drugs marketed in China
    Original research import
    Original research import


    1.  

    Esmolol Hydrochloride and Sodium Chloride Injection

    Esmolol Hydrochloride and Sodium Chloride Injection

    100ml: 2g esmolol hydrochloride and 0.
    41g sodium chloride

    Shanghai Baxter Medical Products Co.
    , Ltd.

    Drugs produced in China by foreign original research companies that have been reviewed and determined

    Original research real estate


    1.  

    1.  
  •  
    • Esmolol Hydrochloride and Sodium Chloride Injection
    Esmolol Hydrochloride and Sodium Chloride Injection
    Esmolol Hydrochloride and Sodium Chloride Injection
    Esmolol Hydrochloride and Sodium Chloride Injection
    100ml: 2g esmolol hydrochloride and 0.
    41g sodium chloride
    100ml: 2g esmolol hydrochloride and 0.
    41g sodium chloride
    Shanghai Baxter Medical Products Co.
    , Ltd.
    Shanghai Baxter Medical Products Co.
    , Ltd.
    Drugs produced in China by foreign original research companies that have been reviewed and determined
    Drugs produced in China by foreign original research companies that have been reviewed and determined
    Original research real estate
    Original research real estate


    1.  

    Gadolinium meglumine injection

    Gadobenate Dimeglumine Injection

    10.
    58GM/20ML (529MG/ML)

    Bracco Diagnostics Inc.

    No imported original research drugs

    American Orange Book


    1.  

    1.  
  •  
    • Gadolinium meglumine injection
    Gadolinium meglumine injection
    Gadobenate Dimeglumine Injection
    Gadobenate Dimeglumine Injection
    10.
    58GM/20ML (529MG/ML)
    10.
    58GM/20ML (529MG/ML)
    Bracco Diagnostics Inc.
    Bracco Diagnostics Inc.
    No imported original research drugs
    No imported original research drugs
    American Orange Book
    American Orange Book


    1.  

    Dexrazoxane for injection

    Dexrazoxane for Injection/Totect

    500mg

    Clinigen, Inc.

    No imported original research drugs

    American Orange Book


    1.  

    1.  
  •  
    • Dexrazoxane for injection
    Dexrazoxane for injection
    Dexrazoxane for Injection/Totect
    Dexrazoxane for Injection/Totect
    500mg
    500mg
    Clinigen, Inc.
    Clinigen, Inc.
    No imported original research drugs
    No imported original research drugs
    American Orange Book
    American Orange Book


    1.  

    Lenalidomide capsules

    Lenalidomide Capsules/Revlimid

    10mg

    Celgene Corporation

    No imported original research drugs

    American Orange Book


    1.  

    1.  
  •  
    • Lenalidomide capsules
    Lenalidomide capsules
    Lenalidomide Capsules/Revlimid
    Lenalidomide Capsules/Revlimid
    10mg
    10mg
    Celgene Corporation
    Celgene Corporation
    No imported original research drugs
    No imported original research drugs
    American Orange Book
    American Orange Book


    1.  

    Lenalidomide capsules

    Lenalidomide Capsules/Revlimid

    25mg

    Celgene Corporation

    No imported original research drugs

    American Orange Book


    1.  

    1.  
  •  
    • Lenalidomide capsules
    Lenalidomide capsules
    Lenalidomide Capsules/Revlimid
    Lenalidomide Capsules/Revlimid
    25mg
    25mg
    Celgene Corporation
    Celgene Corporation
    No imported original research drugs
    No imported original research drugs
    American Orange Book
    American Orange Book


    1.  

    Efavirenz Lamivudine Tenofovir Tablets

    Efavirenz Lamivudine and tenofovir Disoproxil Fumarate Tablets/Symfi

    Each tablet contains efavirenz 600mg, lamivudine 300mg and tenofovir disoproxil fumarate 300mg

    Mylan Laboratories Ltd

    No imported original research drugs

    American Orange Book


    1.  

    1.  
  •  
    • Efavirenz Lamivudine Tenofovir Tablets
    Efavirenz Lamivudine Tenofovir Tablets
    Efavirenz Lamivudine and tenofovir Disoproxil Fumarate Tablets/Symfi
    Efavirenz Lamivudine and tenofovir Disoproxil Fumarate Tablets/Symfi
    Each tablet contains efavirenz 600mg, lamivudine 300mg and tenofovir disoproxil fumarate 300mg
    Each tablet contains efavirenz 600mg, lamivudine 300mg and tenofovir disoproxil fumarate 300mg
    Mylan Laboratories Ltd
    Mylan Laboratories Ltd
    No imported original research drugs
    No imported original research drugs
    American Orange Book
    American Orange Book


    1.  

    Potassium chloride oral solution

    Potassium Chloride Oral Solution

    20mEq/15ml
    (473ml)

    Genus Life Sciences Inc

    No imported original research drugs

    American Orange Book


    1.  

    1.  
  •  
    • Potassium chloride oral solution
    Potassium chloride oral solution
    Potassium Chloride Oral Solution
    Potassium Chloride Oral Solution
    20mEq/15ml
    (473ml)
    20mEq/15ml
    (473ml)

    Genus Life Sciences Inc
    Genus Life Sciences Inc
    No imported original research drugs
    No imported original research drugs
    American Orange Book
    American Orange Book


    1.  

    Ramipril tablets

    Ramipril Tablets/
    Tritace

    2.
    5mg

    Sanofi Belgium

    No imported original research drugs

    EU listing


    1.  

    1.  
  •  
    • Ramipril tablets
    Ramipril tablets
    Ramipril Tablets/
    Tritace
    Ramipril Tablets/
    Tritace
    2.
    5mg
    2.
    5mg
    Sanofi Belgium
    Sanofi Belgium
    No imported original research drugs
    No imported original research drugs
    EU listing
    EU listing


    1.  

    Ramipril tablets

    Ramipril Tablets/
    Tritace

    5mg

    Sanofi Belgium

    No imported original research drugs

    EU listing


    1.  

    1.  
  •  
    • Ramipril tablets
    Ramipril tablets
    Ramipril Tablets/
    Tritace
    Ramipril Tablets/
    Tritace
    5mg
    5mg
    Sanofi Belgium
    Sanofi Belgium
    No imported original research drugs
    No imported original research drugs
    EU listing
    EU listing


    1.  

    Amorolfine Hydrochloride Liniment

    Amorolfine Hydrochloride Liniment

    0.
    05%

    Galderma International

    No imported original research drugs

    EU listing


    1.  

    1.  
  •  
    • Amorolfine Hydrochloride Liniment
    Amorolfine Hydrochloride Liniment
    Amorolfine Hydrochloride Liniment
    Amorolfine Hydrochloride Liniment
    0.
    05%
    0.
    05%
    Galderma International
    Galderma International
    No imported original research drugs
    No imported original research drugs
    EU listing
    EU listing


    1.  

    Various oil and fat emulsion injections (C6～24)

    Multi-Oil Fat Emulsion Injection (C6～24)

    1000 ml

    Fresenius Kabi AB

    No imported original research drugs

    EU listing


    1.  

    1.  
  •  
    • Various oil and fat emulsion injections (C6～24)
    Various oil and fat emulsion injections (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    1000 ml
    1000 ml
    Fresenius Kabi AB
    Fresenius Kabi AB
    No imported original research drugs
    No imported original research drugs
    EU listing
    EU listing


    1.  

    Various oil and fat emulsion injections (C6～24)

    Multi-Oil Fat Emulsion Injection (C6～24)

    500 ml

    Fresenius Kabi AB

    No imported original research drugs

    EU listing


    1.  

    1.  
  •  
    • Various oil and fat emulsion injections (C6～24)
    Various oil and fat emulsion injections (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    500 ml
    500 ml
    Fresenius Kabi AB
    Fresenius Kabi AB
    No imported original research drugs
    No imported original research drugs
    EU listing
    EU listing


    1.  

    Various oil and fat emulsion injections (C6～24)

    Multi-Oil Fat Emulsion Injection (C6～24)

    250 ml

    Fresenius Kabi AB

    No imported original research drugs

    EU listing


    1.  

    1.  
  •  
    • Various oil and fat emulsion injections (C6～24)
    Various oil and fat emulsion injections (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    250 ml
    250 ml
    Fresenius Kabi AB
    Fresenius Kabi AB
    No imported original research drugs
    No imported original research drugs
    EU listing
    EU listing


    1.  

    Various oil and fat emulsion injections (C6～24)

    Multi-Oil Fat Emulsion Injection (C6～24)

    100 ml

    Fresenius Kabi AB

    No imported original research drugs

    EU listing


    1.  

    1.  
  •  
    • Various oil and fat emulsion injections (C6～24)
    Various oil and fat emulsion injections (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    Multi-Oil Fat Emulsion Injection (C6～24)
    100 ml
    100 ml
    Fresenius Kabi AB
    Fresenius Kabi AB
    No imported original research drugs
    No imported original research drugs
    EU listing
    EU listing


    1.  

    Aminolevulinic acid hexyl ester hydrochloride and special solvent for bladder perfusion

    Hexaminolevulinate Hydrochloride Powder And Solvent For Intravesical Solution/Hexvix

    85mg

    Ipsen Pharma Gmbh

    No imported original research drugs

    EU listing


    1.  

    1.  
  •  
    • Aminolevulinic acid hexyl ester hydrochloride and special solvent for bladder perfusion
    Aminolevulinic acid hexyl ester hydrochloride and special solvent for bladder perfusion
    Hexaminolevulinate Hydrochloride Powder And Solvent For Intravesical Solution/Hexvix
    Hexaminolevulinate Hydrochloride Powder And Solvent For Intravesical Solution/Hexvix
    85mg
    85mg
    Ipsen Pharma Gmbh
    Ipsen Pharma Gmbh
    No imported original research drugs
    No imported original research drugs
    EU listing
    EU listing


    1.  

    Diquafosol Sodium Eye Drops

    Diquafosol Sodium Eye Drops/Diquas

    3% (5ml:150mg)

    Santen Pharmaceutical Co.
    , Ltd.

    No imported original research drugs

    Listed in Japan


    1.  

    1.  
  •  
    • Diquafosol Sodium Eye Drops
    Diquafosol Sodium Eye Drops
    Diquafosol Sodium Eye Drops/Diquas
    Diquafosol Sodium Eye Drops/Diquas
    3% (5ml:150mg)
    3% (5ml:150mg)
    Santen Pharmaceutical Co.
    , Ltd.
    Santen Pharmaceutical Co.
    , Ltd.
    No imported original research drugs
    No imported original research drugs
    Listed in Japan
    Listed in Japan


    1.  

    Sucralfate Oral Suspension

    Sucralfate Oral Suspension /Ulcerlmin

    10ml:1g(10%)

    Fuji Chemical Industry Co.
    , Ltd.

    Unimported original research drugs

    Listed in Japan


    1.  

    1.  
  •  
    • Sucralfate Oral Suspension
    Sucralfate Oral Suspension
    Sucralfate Oral Suspension /Ulcerlmin
    Sucralfate Oral Suspension /Ulcerlmin
    10ml:1g(10%)
    10ml:1g(10%)
    Fuji Chemical Industry Co.
    , Ltd.
    Fuji Chemical Industry Co.
    , Ltd.
    Unimported original research drugs
    Unimported original research drugs
    Listed in Japan
    Listed in Japan


    1.  

    Sodium picosulfate oral solution

    Sodium Picosulfate Oral Solution/Laxoberon

    7.
    5mg/ml

    Sanofi

    No imported original research drugs

    Listed in Japan


    1.  

    1.  
  •  
    • Sodium picosulfate oral solution
    Sodium picosulfate oral solution
    Sodium Picosulfate Oral Solution/Laxoberon
    Sodium Picosulfate Oral Solution/Laxoberon
    7.
    5mg/ml
    7.
    5mg/ml
    Sanofi
    Sanofi
    No imported original research drugs
    No imported original research drugs
    Listed in Japan
    Listed in Japan


    1.  

    Clobazam tablets

    Clobazam Tablets/Frisium

    10mg

    Aventis Pharma Ltd

    No imported original research drugs

    UK listed


    1.  

    1.  
  •  
    • Clobazam tablets
    Clobazam tablets
    Clobazam Tablets/Frisium
    Clobazam Tablets/Frisium
    10mg
    10mg
    Aventis Pharma Ltd
    Aventis Pharma Ltd
    No imported original research drugs
    No imported original research drugs
    UK listed
    UK listed

    10-86

    Riluzole tablets

    Riluzole Tablets/RILUTEK

    50mg

    Aventis Pharma SA /Sanofi Mature IP

    Original research import

    The license holder has changed, and the license holder Sanofi Mature IP is added after the change

    10-86
    10-86
    Riluzole tablets
    Riluzole tablets
    Riluzole Tablets/RILUTEK
    Riluzole Tablets/RILUTEK
    50mg
    50mg
    Aventis Pharma SA /Sanofi Mature IP
    Aventis Pharma SA /Sanofi Mature IP
    Original research import
    Original research import
    The license holder has changed, and the license holder Sanofi Mature IP is added after the change
    The license holder has changed, and the license holder Sanofi Mature IP is added after the change

    10-106

    Midazolam Maleate Tablets

    Midazolam Maleate Tablets/Dormicum

    15mg (calculated as C18H13C1FN3)

    Roche Pharma (Schweiz) Ltd.
    /Roche Pharma (Schweiz) AG/CHEPLAPHARM Arzneimittel GmbH

    Original research import

    The license holder has changed and the license holder Roche Pharma (Schweiz) AG/CHEPLAPHARM Arzneimittel GmbH has been added after the change.

    10-106
    10-106
    Midazolam Maleate Tablets
    Midazolam Maleate Tablets
    Midazolam Maleate Tablets/Dormicum
    Midazolam Maleate Tablets/Dormicum
    15mg (calculated as C18H13C1FN3)
    15mg (calculated as C18H13C1FN3)
    Roche Pharma (Schweiz) Ltd.
    /Roche Pharma (Schweiz) AG/CHEPLAPHARM Arzneimittel GmbH
    Roche Pharma (Schweiz) Ltd.
    /Roche Pharma (Schweiz) AG/CHEPLAPHARM Arzneimittel GmbH
    Original research import
    Original research import
    The license holder has changed and the license holder Roche Pharma (Schweiz) AG/CHEPLAPHARM Arzneimittel GmbH has been added after the change.
    The license holder has changed and the license holder Roche Pharma (Schweiz) AG/CHEPLAPHARM Arzneimittel GmbH has been added after the change.

    16-12

    Albendazole Tablets

    Albendazole Tablets/Shi Ke Chang Chong Qing

    0.
    2g

    Sino-U.
    S.
    Tianjin SmithKline Pharmaceutical Co.
    , Ltd.

    Original research and localized varieties

    The errata of the licensee is Sino-U.
    S.
    Tianjin SmithKline Pharmaceutical Co.
    , Ltd.

    16-12
    16-12
    Albendazole Tablets
    Albendazole Tablets
    Albendazole Tablets/Shi Ke Chang Chong Qing
    Albendazole Tablets/Shi Ke Chang Chong Qing
    0.
    2g
    0.
    2g
    Sino-U.
    S.
    Tianjin SmithKline Pharmaceutical Co.
    , Ltd.
    Sino-U.
    S.
    Tianjin SmithKline Pharmaceutical Co.
    , Ltd.
    Original research and localized varieties
    Original research and localized varieties
    The errata of the licensee is Sino-U.
    S.
    Tianjin SmithKline Pharmaceutical Co.
    , Ltd.
    The errata of the licensee is Sino-U.
    S.
    Tianjin SmithKline Pharmaceutical Co.
    , Ltd.

    21-40

    Concentrated zoledronic acid solution for injection

    Zoledronic Acid Concentrated Solution for Injection/Zometa

    5ml: 4mg

    Novartis Pharma Schweiz AG /Future Health Pharma GmbH

    Original drugs marketed in China

    The license holder has changed, and the license holder Future Health Pharma GmbH will be added after the change.

    21-40
    21-40
    Concentrated zoledronic acid solution for injection
    Concentrated zoledronic acid solution for injection
    Zoledronic Acid Concentrated Solution for Injection/Zometa
    Zoledronic Acid Concentrated Solution for Injection/Zometa
    5ml: 4mg
    5ml: 4mg
    Novartis Pharma Schweiz AG /Future Health Pharma GmbH
    Novartis Pharma Schweiz AG /Future Health Pharma GmbH
    Original drugs marketed in China
    Original drugs marketed in China
    The license holder has changed, and the license holder Future Health Pharma GmbH will be added after the change.
    The license holder has changed, and the license holder Future Health Pharma GmbH will be added after the change.

    Remark

    1.
    The generic names and dosage forms of the varieties listed in the catalogue that have not yet been marketed in China shall be subject to those approved by the Pharmacopoeia Commission
    .
    2.
    After the publication of the reference preparation catalogue, the varieties that have not been officially released will be subject to special research and will be released separately based on the research results
    .
    3.
    The reference preparations marketed in the EU include the same drugs marketed in the UK
    .
    4.
    Selecting non-imported reference preparations to carry out generic drug research should not only meet its quality requirements, but also meet the requirements of the current version of the Chinese Pharmacopoeia and related guidelines
    .

    Remark
    Remark
    1.
    The generic names and dosage forms of the varieties listed in the catalogue that have not yet been marketed in China shall be subject to those approved by the Pharmacopoeia Commission
    .
    2.
    After the publication of the reference preparation catalogue, the varieties that have not been officially released will be subject to special research and will be released separately based on the research results
    .
    3.
    The reference preparations marketed in the EU include the same drugs marketed in the UK
    .
    4.
    Selecting non-imported reference preparations to carry out generic drug research should not only meet its quality requirements, but also meet the requirements of the current version of the Chinese Pharmacopoeia and related guidelines
    .
    1.
    The generic names and dosage forms of the varieties listed in the catalogue that have not yet been marketed in China shall be subject to those approved by the Pharmacopoeia Commission
    .
    2.
    After the publication of the reference preparation catalogue, the varieties that have not been officially released will be subject to special research and will be released separately based on the research results
    .
    3.
    The reference preparations marketed in the EU include the same drugs marketed in the UK
    .
    4.
    Selecting non-imported reference preparations to carry out generic drug research should not only meet its quality requirements, but also meet the requirements of the current version of the Chinese Pharmacopoeia and related guidelines
    .
     
    　　State Food and Drug Administration
     
    　　July 22, 2021
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.
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