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The State Food and Drug Administration on the Publication of the Catalogue of Generic Drug Reference Preparations (60th Batch)

 Last Update: 2022-10-13
 Source: Internet
 Author: User

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After the review and confirmation of the Expert Committee on the Consistency Evaluation of Generic Drugs and Efficacy of the State Drug Administration, the Catalogue of Generic Reference Preparations (60th Batch)
is hereby published.

Notice is hereby given
.

Annex: Catalogue of Generic Reference Formulations (60th Batch)

State Food and Drug Administration

September 29, 2022

serial number	The generic name of the drug	English name/trade name	specification	Licensees	Note 1	Note 2
	Lamivudin dotiraviravir tablets	Lamivudine and Dolutegravir Sodium Tablets/Dovito	Each tablet contains lamivudine 300 mg and dotiravir sodium (in terms of dolutelavir) 50 mg	ViiV Healthcare B. V.	Originally researched drugs listed in China	Original research imports
	Phosphorus/sodium bicarbonate hemofiltration exchange	Hemofiltration Replacement Fluid of Sodium Bicarbonate and Phosphate	5000ml（250ml/4750ml）	Gambro Lundia AB	Originally researched drugs listed in China	Original research imports
	Miconazole oral patch	Miconazole Buccal Tablet/Nomiko	50 mg	VECTANS PHARMA	Originally researched drugs listed in China	Original research imports
	Lumeperilon toluenesulfonate capsules	Lumateperone tosylate capsule/Caplyta	42 mg (in lutepirolone)	Intra-Cellular Therapies Inc	No original drugs have been imported	American Orange Book
	Compound electrolyte injection	Multiple Electrolytes Injection/Plasma-Lyte A	500ml	Baxter Healthcare Corp	No original drugs have been imported	American Orange Book
	Sodium bicarbonate injection	Sodium Bicarbonate Injection	0. 9MEQ/ML（7. 5%）	Exela Pharma Sciences LLC	Internationally recognized homogeneous medicine	American Orange Book
	Sodium bicarbonate injection	Sodium Bicarbonate Injection	1MEQ/ML（8. 4%）	Exela Pharma Sciences LLC	Internationally recognized homogeneous medicine	American Orange Book
	Nedreone tablets	Finerenone Tablets/Kerendia	10mg	Bayer Healthcare Pharmaceuticals INC	No original drugs have been imported	American Orange Book
	Nedreone tablets	Finerenone Tablets/Kerendia	20mg	Bayer Healthcare Pharmaceuticals INC	No original drugs have been imported	American Orange Book
	Clobenzazole acid softgels	Tafamidis soft Capsules / Vyndamax	61mg	Foldrx Pharmaceuticals LLC A Wholly Owned Sub Of Pfizer INC	No original drugs have been imported	American Orange Book
	Aminocaproic acid oral solution	Aminocaproic Acid Oral Solution /Amicar	0. 25 g/ml	Akorn Operating CO LLC	No original drugs have been imported	American Orange Book
	Velisius tablets	Vericiguat Tablets/Verquvo	2. 5mg	Merck Sharp And Dohme Corp	No original drugs have been imported	American Orange Book
	Velisius tablets	Vericiguat Tablets/Verquvo	5mg	Merck Sharp And Dohme Corp	No original drugs have been imported	American Orange Book
	Velisius tablets	Vericiguat Tablets/Verquvo	10mg	Merck Sharp And Dohme Corp	No original drugs have been imported	American Orange Book
	Pharmacalciferol softgels	Doxercalciferol Capsules /Hectorol	2. 5μg	Sanofi Genzyme	No original drugs have been imported	American Orange Book
	Pharmacalciferol softgels	Doxercalciferol Capsules /Hectorol	1μg	Sanofi Genzyme	No original drugs have been imported	American Orange Book
	Pharmacalciferol softgels	Doxercalciferol Capsules /Hectorol	0. 5μg	Sanofi Genzyme	No original drugs have been imported	American Orange Book
	Prednisolone sodium phosphate oral solution	Prednisolone Sodium phosphate Oral solution/ Pediapred	5mg/5ml	Seton Pharmaceutical LLC	No original drugs have been imported	American Orange Book
	Cyclophosphamide injection	Cyclophosphamide Injection	500mg/2. 5ml（200mg/ml）	Ingenus Pharmaceuticals,LLC	No original drugs have been imported	American Orange Book
	Cyclophosphamide injection	Cyclophosphamide Injection	1g/5ml（200mg/ml）	Ingenus Pharmaceuticals,LLC	No original drugs have been imported	American Orange Book
	Cyclophosphamide injection	Cyclophosphamide Injection	2g/10ml（200mg/ml）	Ingenus Pharmaceuticals,LLC	No original drugs have been imported	American Orange Book
	Tofatib citrate oral solution	Tofacitinib Citrate Oral Solution	1mg/ml，240ml	Pfizer Inc.	No original drugs have been imported	American Orange Book
	Finasteride tadalafil capsules	Finasteride and Tadalafil Capsules / Entadfi	5mg/5mg	Veru Inc	No original drugs have been imported	American Orange Book
	Etomidate injection	Etomidate Injection/Amidate	10ml∶20mg	Hospira INC	No original drugs have been imported	American Orange Book
	Mabaroxavir dry suspension	Baloxavir Marboxil for Suspension/Xofluza	2mg/ml	Genentech Inc.	No original drugs have been imported	American Orange Book
	Salicycline hydrochloride tablets	Sarecycline Hydrochloride Tablet/Seysara	60mg	Almirall LLC	No original drugs have been imported	American Orange Book
	Salicycline hydrochloride tablets	Sarecycline Hydrochloride Tablet/Seysara	100mg	Almirall LLC	No original drugs have been imported	American Orange Book
	Salicycline hydrochloride tablets	Sarecycline Hydrochloride Tablet/Seysara	150mg	Almirall LLC	No original drugs have been imported	American Orange Book
	Tiravancin hydrochloride for injection	Telavancin Hydrochloride for Injection/Vibativ	750 mg	Cumberland Pharmaceuticals Inc.	No original drugs have been imported	American Orange Book
	Topiramine eye drops	Tropicamide Ophthalmic Solution/ Mydriacyl	0. 50%	Sandoz INC	No original drugs have been imported	American Orange Book
	Diaminopyridine phosphate tablets	Amifampridine phosphate tablets/Firdapse	10mg	SERB S. A.	No original drugs have been imported	Listed in the European Union
	Bilastine oral solution	Bilastine Oral Solution	2. 5mg/ml	Menarini International Operations Luxembourg S. A. /FAES Farma, S. A.	No original drugs have been imported	Listed in the European Union
	Barnidipine hydrochloride extended-release capsules	Barnidipine Hydrochloride Sustained-Release Capsules / Libradin	10mg	Alfasigma S. p. A.	No original drugs have been imported	Listed in the European Union
	Quingolide hydrochloride tablets	Quinagolide Hydrochloride Tablets/Norprolac	25μg (per C20H33N3O3S)	Ferring Arzneimittel GmbH	No original drugs have been imported	Listed in the European Union
	Quingolide hydrochloride tablets	Quinagolide Hydrochloride Tablets/Norprolac	50μg (according to C20H33N3O3S)	Ferring Arzneimittel GmbH	No original drugs have been imported	Listed in the European Union
	Quingolide hydrochloride tablets	Quinagolide Hydrochloride Tablets/Norprolac	75μg (according to C20H33N3O3S)	Ferring Arzneimittel GmbH	No original drugs have been imported	Listed in the European Union
	Quingolide hydrochloride tablets	Quinagolide Hydrochloride Tablets/Norprolac	150μg (according to C20H33N3O3S)	Ferring Arzneimittel GmbH	No original drugs have been imported	Listed in the European Union
	Tofatib citrate oral solution	Tofacitinib Citrate Oral Solution	1mg/ml，240ml	Pfizer Europe MA EEIG	No original drugs have been imported	Listed in the European Union
	Methylene blue enteric-coated extended-release tablets	Methylthioninium Chloride Enteric-coated Sustained-Release Tablets / Lumeblue	25mg	Alfasigma S. p. A.		Listed in the European Union
	Isoconazole diflucoline cream	Isoconazole Nitrate and Diflucortolone Valerate Cream /Travocort®Cream	1%,0. 1%	LEO Pharma A/S		Listed in the European Union
	Mebevirin hydrochloride tablets	Mebeverine Hydrochloride Tablets / Colofac	135mg	Mylan Products Ltd.	No original drugs have been imported	Listed in the European Union
	Chloral hydrate enema agent	Chloral Hydrate Enemas/ Escre	1. 34g：0. 5g	Kumitsu Sasa Corporation	No original drugs have been imported	Listed in Japan
	Compound polyethylene glycol electrolyte dispersion (II. )	Polyethylene Glycol Electrolytes Powder (II)/Niflec	137. 155g/bag	EAファーマ Co. , Ltd	No original drugs have been imported	Listed in Japan
	Isokonazole nitrate cream	Isoconazole Nitrate Cream/Adestan Cream	1%	バイエル Co. , Ltd	No original drugs have been imported	Listed in Japan
	Lanreotide acetate extended-release injection (pre-charged)	Lanreotide Acetate Sustained-release Injection (a pre-filled syringe)	60mg	Ipsen Pharma	Originally researched drugs listed in China	Original research imports
	Lanreotide acetate extended-release injection (pre-charged)	Lanreotide Acetate Sustained-release Injection (a pre-filled syringe)	90mg	Ipsen Pharma	Originally researched drugs listed in China	Original research imports
	Lanreotide acetate extended-release injection (pre-charged)	Lanreotide Acetate Sustained-release Injection (a pre-filled syringe)	120mg	Ipsen Pharma	Originally researched drugs listed in China	Original research imports
	Alfa calciferol softgel	Alfacalcidol Soft Capsules / Etalpha	1μg	CHEPLAPHARM Arzneimittel GmbH	Originally researched drugs listed in China	Original research imports
	Mabaloxavir tablets	Baloxavir Marboxil Tablets/Xofluza	40mg	Roche Pharma (Schweiz) AG	Originally researched drugs listed in China	Original research imports
	Clopidogrel bisulfate tablets	Clopidogrel Hydrogen Sulphate Tablets/Plavix	75mg	Sanofi (Hangzhou) Pharmaceutical Co. , Ltd	Drugs produced in China by foreign original research enterprises determined by the audit	Original research real estate
	Cefoperazone sodium for injection sulbactam sodium	Cefoperazone Sodium and Sulbactam Sodium for Injection/Shupp Deep	1. 5g(C25H27N9O8S2 1. 0g vs. C8H11NO5S 0. 5g)	Pfizer Inc	Drugs produced in China by foreign original research enterprises determined by the audit	Original research real estate
	Cefoperazone sodium for injection sulbactam sodium	Cefoperazone Sodium and Sulbactam Sodium for Injection/Shupp Deep	1. 0g(C25H27N9O8S2 0. 5g vs. C8H11NO5S 0. 5g)	Pfizer Inc	Drugs produced in China by foreign original research enterprises determined by the audit	Original research real estate
	Nilotinib capsules	Nilotinib Capsules/Tasigna	50mg	Novartis Pharmaceuticals Corp	No original drugs have been imported	American Orange Book
	Nilotinib capsules	Nilotinib Capsules/Tasigna	150mg	Novartis Pharmaceuticals Corp	No original drugs have been imported	American Orange Book
	Nilotinib capsules	Nilotinib Capsules/Tasigna	200mg	Novartis Pharmaceuticals Corp	No original drugs have been imported	American Orange Book
	Ketorolac tromethamine injection	Ketorolac Tromethamine Injection	15mg/ml（1ml:15mg）	Hospira INC.	Internationally recognized homogeneous medicine	American Orange Book
	Cyclosporine softgels	Ciclosporin Soft Capsules/ Neoral	100mg	Novartis Pharmaceuticals Corporation	No original drugs have been imported	American Orange Book
	Inhale the suspension with budesonide	Budesonide Suspension For Inhalation/ Pulmicort Respules	2ml：0. 5mg	Astrazeneca Pharmaceuticals LP	No original drugs have been imported	American Orange Book
	Inhale the suspension with budesonide	Budesonide Suspension For Inhalation/ Pulmicort Respules	2ml：1mg	Astrazeneca Pharmaceuticals LP	No original drugs have been imported	American Orange Book
	Olmesartan cilexel hydrochlorothiazide tablets	Hydrochlorothiazide;Olmesartan Medoxomil /Benicar Hct	20mg/12. 5mg	Daiichi Sankyo Inc	No original drugs have been imported	American Orange Book
	Ibuprofen injection※	Ibuprofen Injection/Caldolor	800MG/8ML (100MG/ML)	Cumberland Pharmaceuticals Inc	No original drugs have been imported	American Orange Book
	Fluvestrant injection	Faslodex 250 mg solution for injection/Faslodex	5ml:0. 25g	AstraZeneca AB/AstraZeneca UK Limited	No original drugs have been imported	Listed in the European Union
	Clobenzazolic acid meglumine softgels	Tafamidis Meglumine Soft Capsules/Vyndaqel	20mg	Pfizer Europe MA EEIG	No original drugs have been imported	Listed in the European Union
	Entacapone tablets	Entacapone Tablets /Comtess	200mg	Orion Pharma GmbH	No original drugs have been imported	Listed in the European Union
	Capagliflozin tablets	Canagliflozin Tablets/Invokana	300mg	Janssen-Cilag International NV,	No original drugs have been imported	Listed in the European Union
	Hydroxychloroquine sulfate tablets	Hydroxychloroquine Sulfate Tablets/Plaquenil	0. 2g	Sanofi-Aventis	No original drugs have been imported	Listed in the European Union
	Selenium disulfide lotion	Selenium Sulfide Lotion/Selsun	2. 5%	Sanofi-Aventis Netherlands B. V. / Opella Healthcare France SAS	No original drugs have been imported	Listed in the European Union
	Carbonate sveram dry suspension	Sevelamer Carbonate Powder for oral suspension/Renvela	0. 8g	Genzyme Europe B. V.	No original drugs have been imported	Listed in the European Union
	Carbonate sveram dry suspension	Sevelamer Carbonate Powder for oral suspension/Renvela	2. 4g	Genzyme Europe B. V.	No original drugs have been imported	Listed in the European Union
	Daheparin sodium injection	Dalteparin Sodium Injection/Fragmin	0. 2ml:2500IU	Pfizer Pharma Pfe GmbH	No original drugs have been imported	Listed in the European Union
	Bisacoridine enteric-coated tablets	Bisacodyl Enteric-coated Tablets/Dulcolax	5mg	Opella Healthcare France SAS	No original drugs have been imported	Listed in the European Union
	Venlafaxine hydrochloride extended-release capsules	Venlafaxine Hydrochloride Sustained-Release Capsules/Efexor XL	75 mg (in venlafaxine)	Upjohn UK Limited	No original drugs have been imported	Listed in the European Union
	Venlafaxine hydrochloride extended-release capsules	Venlafaxine Hydrochloride Sustained-Release Capsules/Efexor XL	150 mg (in venlafaxine)	Upjohn UK Limited	No original drugs have been imported	Listed in the European Union
	Calcitriol injection	Calcitriol Injection/Rocaltrol	1ml:0. 5μg	キリン	No original drugs have been imported	Listed in Japan
	Calcitriol injection	Calcitriol Injection/Rocaltrol	1ml:1μg	キリン	No original drugs have been imported	Listed in Japan
5-43	Paroxetine hydrochloride tablets	Paroxetine Hydrochloride Tablets/Paxil	20mg	Apotex Technologies Inc/Apotex Inc	No original drugs have been imported	Increase licensee Apotex Inc
10-132	Pravastatin sodium tablets	Pravastatin Sodium Tablet/Sanaprav	40mg	DAIICHI SANKYO ITALIA S. p. A. /Daiichi Sankyo Belgium S. A/Daiichi Sankyo Europe Gmbh	Listed in the European Union	Add licensee Daiichi Sankyo Belgium S. A/Daiichi Sankyo Europe Gmbh, regardless of the country of listing and place of origin
10-194	Trazodone hydrochloride tablets	Trazodone Hydrochloride Tablets/RESLIN	25mg	MSD K. K. /オルガノン	Japanese Orange Book	オルガノン Co. , Ltd
10-195	Trazodone hydrochloride tablets	Trazodone Hydrochloride Tablets/RESLIN	50mg	MSD K. K. /オルガノン	Japanese Orange Book	オルガノン Co. , Ltd
23-166	Lidocaine hydrochloride injection	Lidocaine Hydrochloride Injection	2% (in C14H22N2O• HCL) (5ml, 10ml, 20ml)	Aspen/Aspen Pharma Trading Limited	No original drugs have been imported	Additional Holders: Aspen Pharma Trading Limited, no trade name
26-167	Dopamine hydrochloride injection	Dopamine Hydrochloride Injection/Inovan	2. 5ml:50mg	キリン Corporation/キリン Ltd	No original drugs have been imported	Increase the Warrant Merchant Association and キリン
26-168	Dopamine hydrochloride injection	Dopamine Hydrochloride Injection/Inovan	5ml:100mg	キリン Corporation/キリン Ltd	No original drugs have been imported	Increase the Warrant Merchant Association and キリン
26-1	Fluticasone propionate cream	Fluticasone Propionate Cream/Cutivate	0. 05% (package size 15, 30, 50, 100g)	Glaxo Wellcome/GlaxoSmithKline/GlaxoSmithKline（Ireland）Limited	No original drugs have been imported	Additional Holders: GlaxoSmithKline (Ireland) Limited
26-106	Eba butavastatin calcium tablets	Ezetimibe and Atorvastatin Calcium Trihydrate Tablets	10mg/10mg	Merck Sharp & Dohme/Organon Healthcare GmbH /Organon France	No original drugs have been imported	Increase in licensee Organon France
26-107	Eba butavastatin calcium tablets	Ezetimibe and Atorvastatin Calcium Trihydrate Tablets	10mg/20mg	Merck Sharp & Dohme/Organon Healthcare GmbH /Organon France	No original drugs have been imported	Increase in licensee Organon France
27-237	Hydroxyethyl starch 130/0. 4 sodium chloride injection	Hydroxyethyl Starch 130/0. 4 and Sodium Chloride Injection/Voluven Fresenius	Hydroxyethyl starch 130/0. 4: 60g/L, sodium chloride: 9. 0g/L (250ml, 500ml)	Fresenius Kabi Deutschland GmbH/Fresenius Kabi Italia S. r. l. /Fresenius Kabi Pharma Portugal, Lda	No original drugs have been imported	Increase the number of licensees Fresenius Kabi Pharma Portugal, Lda,
27-268	Chlorine / nitrate / Cyprine / pan injection	Clonazepam Injection	1ml:1mg	Roche Pharma（Schweiz）AG/CPS Cito Pharma Services GmbH	No original drugs have been imported	Increase the number of licensees CPS Cito Pharma Services GmbH
27-372	Paroxetine hydrochloride tablets	Paroxetine Hydrochloride Tablets/Paxil	40mg	Apotex Technologies Inc/Apotex Inc	No original drugs have been imported	Increase licensee Apotex Inc
30-149	Epinephrine hydrochloride injection / epinephrine injection	Epinephrine Injection/ADRENALIN	1ml:1mg	Par Pharmaceutical, Inc/Par Sterile Products Llc	No original drugs have been imported	Add licensee Par Sterile Products Llc
33-24	Acetylcysteine oral solution	Acetylcysteine Oral Solution	2%（50ml、100ml、200ml）	Zambon GmbH	No original drugs have been imported	Name is not limited
42-48	Paroxetine hydrochloride tablets	Paroxetine Hydrochloride Tablets/Paxil	10mg	Apotex Technologies Inc/Apotex Inc	No original drugs have been imported	Increase licensee Apotex Inc
42-49	Paroxetine hydrochloride tablets	Paroxetine Hydrochloride Tablets/Paxil	30mg	Apotex Technologies Inc/Apotex Inc	No original drugs have been imported	Increase licensee Apotex Inc
42-51	Fluticasone propionate cream	Fluticasone Propionate Cream	0. 05%	Perrigo Israel Pharmaceuticals Ltd / Padagis Israel Pharmaceuticals Ltd	Internationally recognized homogeneous medicine	Increase the number of licensees Padagis Israel Pharmaceuticals Ltd
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 . 6. Ibuprofen injection ※: When imitating this product, special attention should be paid to the stability of the basic infusion compatibility to meet the clinical needs .

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