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China Food and Drug Administration released the catalog of generic drug reference preparations (42nd batch)

 Last Update: 2021-08-09
 Source: Internet
 Author: User

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According to the news on June 29, the National Medical Products Administration of the State Drug Administration of the State Drug Administration of the Quality and Efficacy Consistency Evaluation Expert Committee confirmed that the list of generic reference preparations (the 42nd batch) is now released
.
Hereby inform
.

Attachment: List of Generic Drug Reference Preparations (Forty-second batch)

Serial number	Generic name of the drug	English name/trade name	Specification	Licensee	Remark 1	Remark 2
	Ezetimibe Simvastatin Tablets	Ezetimibe and Simvastatin Tablets/Bao Zhineng	Each tablet contains 10mg of ezetimibe and 20mg of simvastatin	Merck Sharp & Dohme BV	Original drugs marketed in China	Original research import
	Ezetimibe Simvastatin Tablets	Ezetimibe and Simvastatin Tablets/Bao Zhineng	Each tablet contains 10mg of ezetimibe and 40mg of simvastatin	Merck Sharp & Dohme BV	Original drugs marketed in China	Original research import
	Granisetron transdermal patch	Granisetron Transdermal Patches	34. 3mg/52cm2 (released amount 3. 1mg/24h)	ProStrakan	Original drugs marketed in China	Original research import
	Omega-3 fish oil fat emulsion injection	ω-3 Fish Oil Fat Emulsion Injection/Omegaven	50ml: 5g (refined fish oil): 0. 6g (lecithin)	Fresenius Kabi Austria GmbH	Original drugs marketed in China	Original research import
	Obucaine Hydrochloride Eye Drops	Oxybuprocaine Hydrochloride Eye Drops / Benoxil	0. 4% (0. 5ml:2mg)	Santen Pharmaceutical Co. , Ltd.	Original drugs marketed in China	Original research import
	10% fat emulsion (OO)/5. 5% amino acid (15)/glucose (20%) injection	10% Fat Emulsion(OO)/5. 5% Amino Acids(15)/Glucose(20%) Injection/Oliclinomel	1500ml: 10% olive oil fat emulsion 300ml+5. 5% compound amino acid injection (15) 600ml+20% glucose injection 600ml	Baxter SA	Original drugs marketed in China	Original research import
	10% fat emulsion (OO)/5. 5% amino acid (15)/glucose (20%) injection	10% Fat Emulsion(OO)/5. 5% Amino Acids(15)/Glucose(20%) Injection/Oliclinomel	1000ml: 10% olive oil fat emulsion 200ml+5. 5% compound amino acid injection (15) 400ml+20% glucose injection 400ml	Baxter SA	Original drugs marketed in China	Original research import
	Sodium Benzoate Sodium Phenylacetate Injection	Sodium Phenylacetate and Sodium Benzoate Injection /Ammonul	10%; 10% (5g/50mL; 5g/50mL)	Bausch Health Us LLC	No imported original research drugs	American Orange Book
	Glyceryl Phenylbutyrate Oral Liquid	Glycerol Phenylbutyrate Oral Liquid/Ravicti	1. 1 g/mL	Horizon Therapeutics LLC	No imported original research drugs	American Orange Book
	Cetirizine Hydrochloride Injection	Cetirizine Hydrochloride Injection/Quzyttir	10mg/ml	JDP Therapeutics LLC	No imported original research drugs	American Orange Book
	Lamotrigine sustained-release tablets	Lamotrigine Extended Release Tablets / Lamictal XR	25mg	GlaxoSmithKline LLC	No imported original research drugs	American Orange Book
	Lamotrigine sustained-release tablets	Lamotrigine Extended Release Tablets / Lamictal XR	50mg	GlaxoSmithKline LLC	No imported original research drugs	American Orange Book
	Lamotrigine sustained-release tablets	Lamotrigine Extended Release Tablets / Lamictal XR	100mg	GlaxoSmithKline LLC	No imported original research drugs	American Orange Book
	Lamotrigine sustained-release tablets	Lamotrigine Extended Release Tablets / Lamictal XR	200mg	GlaxoSmithKline LLC	No imported original research drugs	American Orange Book
	Lamotrigine sustained-release tablets	Lamotrigine Extended Release Tablets / Lamictal XR	250mg	GlaxoSmithKline LLC	No imported original research drugs	American Orange Book
	Lamotrigine sustained-release tablets	Lamotrigine Extended Release Tablets / Lamictal XR	300mg	GlaxoSmithKline LLC	No imported original research drugs	American Orange Book
	Bupropion Hydrobromide Sustained Release Tablets	Bupropion Hydrobromide Extended-Release Tablets/Aplenzin	174mg	Valeant Pharmaceuticals North America LLC	No imported original research drugs	American Orange Book
	Bupropion Hydrobromide Sustained Release Tablets	Bupropion Hydrobromide Extended-Release Tablets/Aplenzin	348mg	Valeant Pharmaceuticals North America LLC	No imported original research drugs	American Orange Book
	Bupropion Hydrobromide Sustained Release Tablets	Bupropion Hydrobromide Extended-Release Tablets/Aplenzin	522mg	Valeant Pharmaceuticals North America LLC	No imported original research drugs	American Orange Book
	Riboflavin sodium phosphate eye drops	Riboflavin 5'-Phosphate Ophthalmic Solution/ Photrexa	0. 146%	Glaukos Corporation	No imported original research drugs	American Orange Book
	Azelaic Acid Gel	Azelaic Acid Gel / Finacea	15%	Leo Pharma AS	No imported original research drugs	American Orange Book
	Gemcitabine Hydrochloride Injection	Gemcitabine Hydrochloride Injection	200mg/5. 26ml (38 mg/ml)	Hospira, Inc.	No imported original research drugs	American Orange Book
	Gemcitabine Hydrochloride Injection	Gemcitabine Hydrochloride Injection	1g/26. 3ml (38 mg/ml)	Hospira, Inc.	No imported original research drugs	American Orange Book
	Idarubicin Hydrochloride Injection	Idarubicin Hydrochloride Injection/Idamycin Pfs	1 mg/ml	Pfizer Inc	Unimported original research	American Orange Book
	Fluoxetine Hydrochloride Oral Solution	Fluoxetine Hydrochloride Oral Solution/ Prozac	20mg/5ml	Lilly France	No imported original research drugs	EU listing
	Triamcinolone acetonide and econazole cream	Triamcinolone Acetonide and Econazole Nitrate Cream	Each gram contains econazole nitrate 10mg, triamcinolone acetonide 1. 0mg	Janssen-Cilag	No imported original research drugs	EU listing
	Terbinafine Gel	Terbinafine Gel/Lamisil DermGel	1%	Glaxosmithkline Sante Grand Public	No imported original research drugs	EU listing
	ω-3 fish oil medium and long-chain fat emulsion/amino acid (16)/glucose (16%) injection	ω-3 Fish Oil Medium and Long Chain Fat Emulsion/Amino Acids (16)/Glucose (16%) Injection / NuTRIflex Omega peri	1250ml	B. Braun Melsungen AG	No imported original research drugs	EU listing
	Compound alpha-keto acid tablets	Compound α-Ketoacid Tablets	0. 63g	Fresenius Kabi Deutschland GmbH	No imported original research drugs	EU listing
	Cefcapene Pivoxil Hydrochloride Granules	Cefcapene Pivoxil Hydrochloride Granules /Flomox	10% (1g 100mg containing hydrochloric acid salt hydrate, 50mg/bag)	Shiono Yoshihide Pharmaceutical Co. , Ltd.	No imported original research drugs	Listed in Japan
	Melatonin granules for children	Melatonin granules for pediatric / Melatobel	1g: 2mg	ノーベルファーマ Co. , Ltd.	No imported original research drugs	Listed in Japan
	Nificaran Hydrochloride for Injection	Nifekalant Hydrochloride for Injection / Shinbit	50mg	トアエイヨー Co. , Ltd.	No imported original research drugs	Listed in Japan
	Iron Citrate Tablets	Ferric Citrate Tablet/ Riona Tab 250mg	250mg (calculated as iron citrate)	Torii Pharmaceutical Co. , Ltd.	No imported original research drugs	Listed in Japan
	Baclofen Oral Solution	Baclofen Oral Solution/Lioresal	5mg/5ml	Novartis Pharmaceuticals UK Limited	No imported original research drugs	UK listed
	Atenolol injection	Atenolol Injection/Tenormin	10ml:5mg	AstraZeneca	No imported original research drugs	UK listed
	Paroxetine Hydrochloride Tablets	Paroxetine Hydrochloride Tablets/Sailote	20mg (calculated as C19H20FNO3)	Sino-U. S. Tianjin SmithKline Pharmaceutical Co. , Ltd.	Drugs produced in China by foreign original research companies that have been reviewed and determined	Original research real estate
	Salbutamol Sulfate Inhalation Aerosol	Salbutamol Sulfate Inhalation Aerosol/Proventil-Hfa	90μg/press (calculated as salbutamol)	Kindeva Drug Delivery LP/Merck Sharp & Dohme Corp. /3M Drug Delivery Systems	No imported original research drugs	American Orange Book
	Pantoprazole Sodium for Injection	Pantoprazole Sodium For Injection/ Pantoprazole Sodium	40mg	Hikma Pharmaceuticals LLC	No imported original research drugs	American Orange Book
	Allopurinol Tablets	Allopurinol Tablets /Zyloprim	0. 3g	Casper Parma LLC	No imported original research drugs	American Orange Book
	Enalapril Maleate Tablets	Enalapril Maleate Tablets/Vasotec	5mg	Bausch Health US LLC	No imported original research drugs	American Orange Book
	Enalapril Maleate Tablets	Enalapril Maleate Tablets/Vasotec	10mg	Bausch Health US LLC	No imported original research drugs	American Orange Book
	Enalapril Maleate Tablets	Enalapril Maleate Tablets/Vasotec	20mg	Bausch Health US LLC	No imported original research drugs	American Orange Book
	Cabazitaxel injection	Cabazitaxel Injection/Jevtana	60mg/1. 5ml (40mg/ml)	Sanofi-Aventis US INC	No imported original research drugs	American Orange Book
	Olapali tablets	Olaparib Tablets/Lynparza	100mg	AstraZeneca Pharmaceuticals LP	No imported original research drugs	American Orange Book
	Olapali tablets	Olaparib Tablets/Lynparza	150mg	AstraZeneca Pharmaceuticals LP	No imported original research drugs	American Orange Book
	Trifluridine Tepipyrimidine Tablets	Trifluridine and Tipiracil Hydrochloride Tablets/ Lonsurf	Trifluridine 15mg, tepipyridine hydrochloride 7. 065mg (equivalent to tepipyridine 6. 14mg)	Taiho oncology Inc.	No imported original research drugs	American Orange Book
	Trifluridine Tepipyrimidine Tablets	Trifluridine and Tipiracil Hydrochloride Tablets/ Lonsurf	Trifluridine 20mg, tepipyridine hydrochloride 9. 420mg (equivalent to tepipyridine 8. 19mg)	Taiho oncology Inc	No imported original research drugs	American Orange Book
	Paroxetine Hydrochloride Tablets	Paroxetine Hydrochloride Tablets / Paxil	10mg	Apotex Technologies Inc	No imported original research drugs	American Orange Book
	Paroxetine Hydrochloride Tablets	Paroxetine Hydrochloride Tablets / Paxil	30mg	Apotex Technologies Inc	No imported original research drugs	American Orange Book
	Brivaracetam injection	Brivaracetam Solution for Injection/Briviact	10mg/ml	UCB Inc	No imported original research drugs	American Orange Book
	Fluticasone Propionate Cream	Fluticasone Propionate Cream	0. 05%	Perrigo Israel Pharmaceuticals Ltd	Internationally recognized drugs of the same kind	American Orange Book
	Latanoprost eye drops	Latanoprost Eye Drops/Xalatan	0. 005%	Upjohn US 2 LLC	No imported original research drugs	American Orange Book
	Carprost tromethamine injection	Carboprost Tromethamine Injection/Hemabate	1ml: 250μg	Pfizer Inc	No imported original research drugs	American Orange Book
	Tofacitib Citrate Sustained Release Tablets	Tofacitinib Citrate Extended Release tablets/Xeljanz Xr	22mg	Pfizer Inc	No imported original research drugs	American Orange Book
	Cefoperazone Sodium and Sulbactam Sodium for Injection	Cefoperazone Sodium and Sulbactam Sodium for Injection/Sulperazon	1g (Cefoperazone 0. 5g: Sulbactam 0. 5g)	Pfizer Polska Sp. z oo	No imported original research drugs	EU listing
	Etibatide Injection	Eptifibatide Injection/Integrilin	20mg/10mL	GlaxoSmithKline (Ireland) Limited	No imported original research drugs	EU listing
	Etibatide Injection	Eptifibatide Injection/Integrilin	75mg/100mL	GlaxoSmithKline (Ireland) Limited	No imported original research drugs	EU listing
	Rivaroxaban tablets	Rivaroxaban Tablets/Xarelto	2. 5mg	Bayer AG	No imported original research drugs	EU listing
	Rivaroxaban tablets	Rivaroxaban Tablets/Xarelto	10mg	Bayer AG	No imported original research drugs	EU listing
	Rivaroxaban tablets	Rivaroxaban Tablets/Xarelto	15mg	Bayer AG	No imported original research drugs	EU listing
	Rivaroxaban tablets	Rivaroxaban Tablets/Xarelto	20mg	Bayer AG	No imported original research drugs	EU listing
	Gadoterate meglumine injection	Gadoteric Acid Meglumine Salt Injection/Dotarem	0. 5 mmol/mL (10ml, 15ml, 20ml/bottle)	Guerbet	No imported original research drugs	EU listing
	Vardenafil Hydrochloride Orally Disintegrating Tablets	Vardenafil Hydrochloride Orally disintegrating Tablets/Levitra	10mg	Bayer AG	No imported original research drugs	EU listing
	Methylprednisolone tablets	Methylprednisolon /Medrol	16mg	Pfizer Italia srl	No imported original research drugs	EU listing
	Carrosol Sodium Injection	Carbosulfan Sodium injection/Adona	20ml: 100mg	Nipro ES Fame Co. , Ltd.	No imported original research drugs	Listed in Japan
	Torsemide tablets	Torasemide Tablets/Torem	5mg	Mylan Products Ltd.	No imported original research drugs	UK listed
	Torsemide tablets	Torasemide Tablets/Torem	10mg	Mylan Products Ltd.	No imported original research drugs	UK listed
6-12	Hydroxychloroquine Sulfate Tablets	Hydroxychloroquine Sulfate Tablets/Plaquenil	0. 2g	Aventis Pharma Limited/ Sanofi-aventis Ireland Ltd. T/A SANOFI		，Sanofi-aventis Ireland Ltd. T/A SANOFI
10-223		Crizotinib Capsules/XALKORI	0. 25g	Pfizer Ltd. /PFIZER EUROPE MA EEIG		，PFIZER EUROPE MA EEIG
10-224		Crizotinib Capsules/XALKORI	0. 2g	Pfizer Ltd. /PFIZER EUROPE MA EEIG		，PFIZER EUROPE MA EEIG
17-7		Benidipine Hydrochloride Tablets/	4mg	/Kyowa Kirin Co. , Ltd.		，Kyowa Kirin Co. , Ltd.
17-8		Benidipine Hydrochloride Tablets/	8mg	/Kyowa Kirin Co. , Ltd.		，Kyowa Kirin Co. , Ltd.
17-15		Cinacalcet Hydrochloride Tablets/	25mg	/Kyowa Kirin Co. , Ltd.		，Kyowa Kirin Co. , Ltd.
17-16		Cinacalcet Hydrochloride Tablets/	75mg	/Kyowa Kirin Co. , Ltd.		，Kyowa Kirin Co. , Ltd.
23-18		Lenvatinib Mesilate Capsules/Lenvima（）	4mg	Eisai Europe Ltd. / Eisai GmbH		，Eisai GmbH
24-179		Tafluprost Eye Drops/Tapros（）	0. 0015% (2. 5ml:37. 5μg)	Santen Pharmaceutical Co. ,Ltd.	Original drugs marketed in China	The specification is updated to 0. 0015% (2. 5ml:37. 5μg)
27-235	Beraprost Sodium Tablets	Beraprost Sodium Tablets	40μg	Takeda Pharma Japan Inc. (Teva Pharma Japan Inc)	Internationally recognized drugs of the same kind	Specification revised to 40μg
Remarks	1. The generic names, dosage forms, etc. of the varieties listed in the catalog that have not yet been marketed in China shall be subject to the approval of 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 according to the research results . 3. The reference preparations marketed in the EU include the same drugs marketed in the UK . 4. The selection of unimported reference preparations to carry out generic drug research not only meets its quality requirements, but also needs to meet the requirements of the current version of the Chinese Pharmacopoeia and related guidelines .

National Food and Drug Administration June 22, 2021

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