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The State Food and Drug Administration issued the Catalogue of Generic Drug Reference Preparations (59th Batch)

 Last Update: 2022-10-14
 Source: Internet
 Author: User

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After the review and confirmation of the Expert Committee on the Consistency Evaluation of the Quality and Efficacy of Generic Drugs of the State Drug Administration, the Catalogue of Generic Drug Reference Preparations (59th Batch)
is hereby published.
Notice is hereby given
.
Annex: Catalogue of Generic Reference Preparations (59th Batch)

serial number	The generic name of the drug	English name/trade name	specification	Licensees	Note 1	Note 2
	Iron isomaltohydride injection	Iron Isomaltoside Injection/ MonoFer®	1 ml by Fe: 100 mg	Pharmacosmos A/S	Originally researched drugs listed in China	Original research imports
	Iron isomaltohydride injection	Iron Isomaltoside Injection/ MonoFer®	5 ml according to Fe: 500 mg	Pharmacosmos A/S	Originally researched drugs listed in China	Original research imports
	Iron isomaltohydride injection	Iron Isomaltoside Injection/ MonoFer®	10ml according to Fe: 1000mg	Pharmacosmos A/S	Originally researched drugs listed in China	Original research imports
	Deuterbutylbenzazine tablets	Deutetrabenazine Tablets/Antitan	6mg	Teva Branded Pharmaceutical Products R&D Inc.	Originally researched drugs listed in China	Original research imports
	Deuterbutylbenzazine tablets	Deutetrabenazine Tablets/Antitan	9mg	Teva Branded Pharmaceutical Products R&D Inc.	Originally researched drugs listed in China	Original research imports
	Deuterbutylbenzazine tablets	Deutetrabenazine Tablets/Antitan	12mg	Teva Branded Pharmaceutical Products R&D Inc.	Originally researched drugs listed in China	Original research imports
	Doravelin tablets	Doravirine Tablets/Pifeltro	100mg	Merck Sharp & Dohme B. V.	Originally researched drugs listed in China	Original research imports
	Dorametes tablets	Doravirine, Lamivudine and Tenofovir Disoproxil Fumarate Tablets/Delstrigo	Each tablet contains 100 mg of doravirin, 300 mg of lamivudine and 300 mg of tenofovir disoproxil fumarate	Merck Sharp & Dohme B. V.	Originally researched drugs listed in China	Original research imports
	Polyethylene glycol sodium potassium scatter	Macrogol Sodium Potassium Powder/Movicol	13. 8g/pack	Bridging Pharma Limited	Originally researched drugs listed in China	Original research imports
	Compound electrolyte injection (II. )	Multiple Electrolytes Injection（Ⅱ）	500ml	B. Braun Melsungen AG	Originally researched drugs listed in China	Original research imports
	Ethosuximide softgels	Ethosuximide Capsules / Zarontin	250mg	Parke Davis Div Warner Lambert Co	No original drugs have been imported	American Orange Book
	Paroxetine hydrochloride suspension	Paroxetine Hydrochloride Oral Suspension/Paxil	10mg/5ml	Apotex Corp.	No original drugs have been imported	American Orange Book
	Calcipotriene cream	Calcipotriol Cream /Dovonex	0. 005%	Leo Pharma As	No original drugs have been imported	American Orange Book
	Oxymetazoline hydrochloride eye drops	Oxymetazoline Hydrochloride Ophthalmic Solution/Upneeq	0. 1%（0. 3ml:0. 3mg）	Rvl Pharmaceuticals Inc	No original drugs have been imported	American Orange Book
	Sodium lactate Ringer injection	Lactated Ringers Injection/Lactated Ringers In Plastic Container	500ml	Baxter Healthcare Corp	No original drugs have been imported	American Orange Book
	Nedreone tablets	Finerenone Tablet/Kerendia	10mg	Bayer Healthcare Pharmaceuticals Inc	No original drugs have been imported	American Orange Book
	Nedreone tablets	Finerenone Tablet/Kerendia	20mg	Bayer Healthcare Pharmaceuticals Inc	No original drugs have been imported	American Orange Book
	Cistoconedide inhales an aerosol	Ciclesonide Inhalation Aerosol/Alvesco	0. 08MG/INH	Covis Pharma Gmbh	No original drugs have been imported	American Orange Book
	Cistoconedide inhales an aerosol	Ciclesonide Inhalation Aerosol/Alvesco	0. 16MG/INH	Covis Pharma Gmbh	No original drugs have been imported	American Orange Book
	Vancomycin hydrochloride capsules	Vancomycin Hydrochloride Capsules/Vancocin	125mg	ANI Pharmaceutical Inc	No original drugs have been imported	American Orange Book
	Vancomycin hydrochloride capsules	Vancomycin Hydrochloride Capsules/Vancocin	250mg	ANI Pharmaceutical Inc	No original drugs have been imported	American Orange Book
	Sorbitol mannitol rinse	Sorbitol Mannitol Irrigation Solution	3000ml	Icu Medical Inc	No original drugs have been imported	American Orange Book
	Sodium bicarbonate injection	Sodium Bicarbonate Injection	0. 5MEQ/ML	Exela Pharma Sciences Llc	Internationally recognized homogeneous medicine	American Orange Book
	Phosphorus/sodium bicarbonate hemofiltration exchange	Biphozyl Solution for haemodialysis / haemofiltration/Biphozyl 22 mmol/l	5000ml（250ml/4750ml）	Baxter Holding B. V.	No original drugs have been imported	Listed in the European Union
	Sodium bicarbonate hemofiltration exchange solution	Prismasol 2 mmol/l Potassium solution for haemodialysis/haemofiltration/Prismasol 2 mmol/l Potassium	5000ml（250ml/4750ml）	Baxter Holding B. V.	No original drugs have been imported	Listed in the European Union
	Dotiraviril pivirine tablets	Dolutegravir and Rilpivirine Tablets	50mg/25mg	ViiV Healthcare BV	No original drugs have been imported	Listed in the European Union
	Compound electrolyte injection (II. )	Sterofundin ISO solution for infusion/ Sterofundin ISO	250ml	B. Braun Melsungen AG	No original drugs have been imported	Listed in the European Union
	Urea [13C] breath test diagnostic kit	Helicobacter Test Infai	75 mg/bottle	Infai GmbH	No original drugs have been imported	Listed in the European Union
	Critrimazole vaginal cream	Clotrimazole Vaginal Cream/ Canesten	10%	Bayer plc	No original drugs have been imported	Listed in the European Union
	Oral solution of deferoxone	Deferiprone Oral Solution/Ferriprox	1ml：100mg	Chiesi Farmaceutici S. p. A.	No original drugs have been imported	Listed in the European Union
	Galantamine hydrobromide oral solution	Galanthamine Hydrobromide Oral Solution/Reminyl	4mg/ml	Janssen-Cilag AB	No original drugs have been imported	Listed in the European Union
	Ketoprofen spray	Ketoprofen 10% Cutaneous Spray/ Ketospray	100mg/ml； 12. 5ml/bottle and 25ml/bottle	Cyathus Exquirere Pharmaforschungs GmbH		Listed in the European Union
	Efferfen patch	Esflurbiprofen Patches /Loqoa Tape	40 mg/patch (10cm×14cm)	Taisho Sakura Corporation	No original drugs have been imported	Listed in Japan
	Adenosine for injection	Arasena-A For Intravenous Infusion 300mg	300 mg/bottle	Mata Sakura Corporation	No original drugs have been imported	Listed in Japan
	Alamoline hydrochloride tablets	Anamorelin Hydrochloride Tablets /Adlumiz	50mg	Ono Sakuba Industrial Co. , Ltd	No original drugs have been imported	Listed in Japan
	Briprazole oral tablets	Brexpiprazole Orally Disintegrating Tablets/Rexulti®OD Tablets	0. 5mg	Otsuka Pharmaceutical Co. , Ltd.	No original drugs have been imported	Listed in Japan
	Briprazole oral tablets	Brexpiprazole Orally Disintegrating Tablets/Rexulti®OD Tablets	1mg	Otsuka Pharmaceutical Co. , Ltd.	No original drugs have been imported	Listed in Japan
	Briprazole oral tablets	Brexpiprazole Orally Disintegrating Tablets/Rexulti®OD Tablets	2mg	Otsuka Pharmaceutical Co. , Ltd.	No original drugs have been imported	Listed in Japan
	Sodium acetate Ringer injection	Sodium Acetate Ringers Injection/Veen F Inj.	500 ml: sodium chloride 3. 0 g, potassium chloride 0. 15 g, calcium chloride (dihydrate) 0. 10 g, sodium acetate (trihydrate) 1. 90 g	Fuso Cutters Industrial Co. , Ltd	No original drugs have been imported	Listed in Japan
	Sodium, potassium, magnesium, calcium glucose injection/compound sodium acetate Ringer injection	Sodium Potassium Magnesium Calcium and Glucose Injection/Physio 140	250ml	Otsuka Manufacturing Co. , Ltd	No original drugs have been imported	Listed in Japan
	Sodium bicarbonate Ringer injection	Sodium Bicarbonate Ringer’s Injection/Bicanate	1000ml	Otsuka Sho Corporation	No original drugs have been imported	Listed in Japan
	Amphotericin B oral suspension	Amphotericin B for Oral Suspension /Fungizone	100mg/mL	クリニジェン	No original drugs have been imported	Listed in Japan
	Clemastine fumarate syrup	Clemastine Fumarate/Tavegal	0. 01%	Nisshin Sakura Corporation	No original drugs have been imported	Listed in Japan
	Clarithromycin lactamate for injection	Powder for Concentrate for Solution for Infusion Clarithromycin/ Klaricid	500mg	Mylan Products Limited		Listed in the UK
	Lidocaine spray	Lidocaine Spray/Xylocaine 10mg Spray	10 mg/spray, 50 ml/bottle	Aspen Pharma Trading Limited	No original drugs have been imported	Listed in the UK
	Polyethylene glycol sodium potassium powder / compound polyethylene glycol (3350) electrolyte dispersion	Movicol Paediatric Chocolate Flavour 6. 9g Sachet, Powder For Oral Solution / Movicol	6. 9g/bag containing polyethylene glycol 3350 6. 563g; Sodium chloride: 0. 1754g;Sodium bicarbonate: 0. 0893g;Potassium chloride: 0. 0159g	Norgine Pharmaceuticals Limited	No original drugs have been imported	Listed in the UK
	Zonisamide oral suspension	Zonisamide Oral Suspension/Desizon	20mg/ml （250ml:5g）	Desitin Arzneimittel GmbH		Listed in the UK
	Strontium chloride [89Sr] injection	Strontium [89Sr] Chloride Injection /metastron	150MBq（4mCi）/4mL	Ge Healthcare Limited	Originally researched drugs listed in China	Original research imports
	Trazodone hydrochloride extended-release tablets	Trazodone Hydrochloride Sustained-release Tablets	150mg	Az. Chim. Riun. Angelini Francesco Acraf S. P. A.	Originally researched drugs listed in China	Original research imports
	Ritonavir tablets	Ritonavir Tablets/Norvir	100mg	Abbvie Inc	No original drugs have been imported	American Orange Book
	Equilibrium salt solution (for perfusion)	Sterile Irrigating Solution（balanced salt solution） / BSS	15mL/stick per milliliter contains 0. 64% sodium chloride, 0. 075% potassium chloride, 0. 048% calcium chloride dihydrate, magnesium chloride hexahydrate, sodium acetate trihydrate 0. 39%, sodium citrate dihydrate 0. 17%	Alcon Laboratories, Inc	No original drugs have been imported	American Orange Book
	Dasatinib tablets	Dasatinib Tablets/Sprycel	70mg	Bristol Myers Squibb Co	No original drugs have been imported	American Orange Book
	Olotadine hydrochloride eye drops	Olopatadine Hydrochloride Ophthalmic solution/Pataday	0. 70%	Alcon Laboratories Inc	No original drugs have been imported	American Orange Book
	Metformin Enggliflozin tablets	Empagliflozin and Metformin Hydrochloride Tablets/Synjardy	Each tablet contains metformin hydrochloride 500 mg and empagliflozin 12. 5 mg	Boehringer Ingelheim Pharmaceuticals Inc	No original drugs have been imported	American Orange Book
	Fluorine [18F] deoxyglucose injection	Fludeoxyglucose F18 Injection	20-400mCi/ml	Feinstein Institute Medical Research	No original drugs have been imported	American Orange Book
	Naproxen sodium tablets	Naproxen Sodium Tablets /Aleve	200 mg (for a living with naphthalene)	Bayer Vital Gmbh/ Bayer BV / Bayer （Schweiz） AG	No original drugs have been imported	Listed in the European Union
	Doxofylline injection	Doxofylline Injection	10ml:0. 1g	Abc Farmaceutici S. P. A	No original research products have been imported	Listed in the European Union
	Compound polyethylene glycol 3350 electrolyte dispersion	Polyethylene Glycol 3350 Electrolytes Powder/Moviprep Orange	Ascorbic acid 4. 7 g, pegyl 3350 100 g, potassium chloride 1. 015 g, sodium ascorbate 5. 9 g, sodium chloride 2. 691 g, anhydrous sodium sulfate 7. 5 g	Norgine B. V.	No original drugs have been imported	Listed in the European Union
	Risperidone oral solution	Risperidone Oral Solution/Risperdal	0. 1% （100mL:100mg）	Janssen Cilag SpA	No original drugs have been imported	Listed in the European Union
	Injection with idarubicin hydrochloride	Idarubicin Hydrochloride For Injection	5mg	ファイザー Co. , Ltd. (Pfizer)	No original drugs have been imported	Listed in Japan
	Pipercille tablets	Palbociclib Tablets/イブランス	25mg	ファイザー Co. , Ltd	No original drugs have been imported	Listed in Japan
	Pipercille tablets	Palbociclib Tablets/イブランス	125mg	ファイザー Co. , Ltd	No original drugs have been imported	Listed in Japan
	Dutasteride softgels	Dutasteride Soft Capsules/Zagallo Capsules	0. 1mg	グラクソスミスクライン	No original drugs have been imported	Listed in Japan
	Cefterenstein tablets	Cefteram Pivoxil Tablets/Tomiron	100mg	Fuji フイルム Toyama Chemical Co. , Ltd	No original drugs have been imported	Listed in Japan
	Cefterenstein tablets	Cefteram Pivoxil Tablets/Tomiron	50mg	Fuji フイルム Toyama Chemical Co. , Ltd	No original drugs have been imported	Listed in Japan
	Acetylcysteine injection	Acetylcysteine Injection/Fluimucil	25ml：5g	Zambon Switzerland Ltd	No original drugs have been imported	Listed in Switzerland
	Acetylcysteine injection	Acetylcysteine Injection/Fluimucil	3ml：300mg	Zambon Switzerland Ltd/Zambon Svizzera SA	No original drugs have been imported	Listed in Switzerland
10-132	Pravastatin sodium tablets	Pravastatin Sodium Tablets/Sanaprav /Prareduct	40mg	Daiichi Sankyo Italia S. P. A. /Daiichi Sankyo Belgium S. A.	Listed in the European Union	Increase the number of licensees, Daiichi Sankyo Belgium S. A. , without restriction on the country of listing and place of origin
10-272	Penicillin V potassium tablets	Phenoxymethylpenicillin Potassium Tablets	0. 5g (800,000)	Sandoz GmbH/Sandoz Inc	American Orange Book	Increase in licensee Sandoz Inc
23-167	Local solution of lidocaine hydrochloride	Lidocaine Hydrochloride Topical Solution/Xylocaine Solution	4% (with C14H22N2O· HCl meter) (20ml, 100ml)	アスペンジャパン/サンドファーマ	No original drugs have been imported	Increased license merchants サンドファーマ Co. , Ltd
25-10	Briracetam injection	Brivaracetam Solution for Injection/Briviact	10mg/ml（5ml）	UCB Pharma S. A. /UCB Pharma Limited	No original drugs have been imported	Increase licensee UCB Pharma Limited
27-231	Dimethylsulfonic acid dexandramine capsules	Lisdexamfetamine Dimesylate capsules/Vyvanse	30mg	Shire Development INC/Takeda Pharmaceuticals USA INC	No original drugs have been imported	Increase licensee Takeda Pharmaceuticals USA INC
27-232	Dimethylsulfonic acid dexandramine capsules	Lisdexamfetamine Dimesylate capsules/Vyvanse	50mg	Shire Development INC/Takeda Pharmaceuticals USA INC	No original drugs have been imported	Increase licensee Takeda Pharmaceuticals USA INC
27-233	Dimethylsulfonic acid dexandramine capsules	Lisdexamfetamine Dimesylate capsules/Vyvanse	70mg	Shire Development INC/Takeda Pharmaceuticals USA INC	No original drugs have been imported	Increase licensee Takeda Pharmaceuticals USA INC
27-269	Chlorine / nitrate / Cyprine / pan injection	Clonazepam Injection/Rivotril	1ml:1mg	Roche Pharma AG /Roche/Cheplapharm Arzneimittel Gmbh	No original drugs have been imported	Add licensee Cheplapharm Arzneimittel Gmbh
29-125	Amoxicillin clavulanate potassium tablets	Amoxicillin and Clavulanate Potassium Tablets/Augmentin	0. 625g（C16H19N3O5S 0. 5g：C8H9NO5 0. 125g）	Beecham Group /Beecham Group Plc	No original drugs have been imported	Increase the number of licensees, Beecham Group Plc
32-16	Sodium valproate extended-release tablets	Compound Sodium Valproate and Valproic Acid Sustained Release Tablets/ Depakine Chrono/Ergenyl chrono	500 mg (as sodium valproate)	Sanofi Aventis France/Sanofi-Aventis Deutschland GmbH/Sanofi S. p. A.	No original drugs have been imported	Increase in licensees Sanofi-Aventis Deutschland GmbH/Sanofi S. p. A.
47-21	Penicillin V potassium tablets	Phenoxymethylpenicillin Potassium Tablets	250mg	Sandoz GmbH/Sandoz Inc	American Orange Book	Increase in licensee Sandoz Inc
10-15	Baclofen tablets	Baclofen Tablets/Lioresal	10mg	Novartis Pharma Schweiz AG/Hemony Pharmaceutical Switzerland GmbH	Original research imports	Change of licensee, addition of the changed licensee Hemony Pharmaceutical Switzerland GmbH
23-76	Tiotropium bromide powder inhaler/tiotropium bromide inhalation powder aerosol	Tiotropium Bromide Powder For Inhalation/Spiriva	18 μg (according to tiotropium, equivalent to tiotropium bromide monohydrate 22. 5 μg)	Boehringer Ingelheim International GmbH	Originally researched drugs listed in China	Revision of specifications and generic names of drugs
remark	1. The generic name, dosage form, etc. of varieties listed in the catalogue that have not been listed in China shall be subject to the approval of the Pharmacopoeia Committee. 2. After the publication of the reference preparation catalog, the varieties that have not been officially released will be studied separately according to the research results . 3. Reference preparations marketed in the European Union include the same drug listed in the UK. 4. In addition to meeting its quality requirements, the selection of unimported reference preparations for generic drug research also needs to meet the requirements of the current edition of the Chinese Pharmacopoeia and related guidelines. 5. Radiopharmaceuticals are different from ordinary chemical drugs, with certain particularities such as radioactivity, timeliness, administration according to radioactivity and other characteristics, reference preparations are mainly used to clarify their research and development goals and basic requirements, according to their drug characteristics at the same time combined with the availability of reference preparations for research .

State Food and Drug Administration September 22, 2022

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