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The State Food and Drug Administration released the 63rd batch of generic drug reference preparations

 Last Update: 2023-02-01
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 Author: User

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After the review and determination of the Expert Committee for the Consistency Evaluation of the Quality and Efficacy of Generic Drugs of the State Medical Products Administration, the list of reference preparations for generic drugs (the sixty-third batch)
is hereby released.
Notice is hereby given
.
Annex: Catalogue of Reference Preparations for Generic Drugs (Batch 63)

serial number	Generic name of the drug	English name/trade name	specification	Licensees	Note 1	Note 2
1	Xylozolin hydrochloride nasal spray	Xylometazoline Hydrochloride Nasal Spray	10mL: 10mg, total spray 63 times, spray volume per spray 140mg	GSK Consumer Healthcare Schweiz AG	Original drugs marketed in China	Original research import
2	Tofacitinib citrate sustained-release tablets	Tofacitinib Citrate Sustained-release Tablets/Xeljanz	11mg	Pfizer Inc	Original drugs marketed in China	Original research import
2	Absolute ethanol injection	Anhydrous Ethanol Injection/ABLYSINOL	99%（5ml）	BELCHER PHARMACEUTICALS LLC	Original drugs have not been imported	American Orange Book
3	Bepedosic acid ezetimibe tablets	Bempedoic Acid and Ezetimibe Tablets/NEXLIZET	180mg/10mg	Esperion Therapeutics	Original drugs have not been imported	American Orange Book
4	Fluoro[18F]toxipir injection	Flortaucipir F 18 injection/TAUVID	30ML(8. 1-51mCi/ML)；	Avid Radiopharmaceuticals Inc	Original drugs have not been imported	American Orange Book
5	Fluoro[18F]toxipir injection	Flortaucipir F 18 injection/TAUVID	50ML(8. 1-51mCi/ML)	Avid Radiopharmaceuticals Inc	Original drugs have not been imported	American Orange Book
6	Neomycin polymyxin B dexamethasone eye drops	Neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension/Maxitrol	5ml: Each ml contains neomycin sulfate (according to neomycin) 3. 5mg, polymyxin B sulfate 10,000, dexamethasone 0. 1%.	Novartis Pharmaceuticals Corporation/Imprimis Pharms USA	Original drugs have not been imported	American Orange Book
7	Retinoids for topical milk	Tretinoin Lotion/Altreno	0. 05%	Dow Pharmaceutical Sciences	Original drugs have not been imported	American Orange Book
9	Compound amino acid injection (17AA-SF)	PROSOL 20% SULFITE FREE IN PLASTIC ConTAINER	20%（2000ml）	BAXTER HLTHCARE	Original drugs have not been imported	American Orange Book
	Thafenamide mesylate tablets	Safinamidemesylate Tablets/XADAGO	50mg	MDD US Operations LLC	Original drugs have not been imported	American Orange Book
	Thafenamide mesylate tablets	Safinamidemesylate Tablets/XADAGO	100mg	MDD US Operations LLC	Original drugs have not been imported	American Orange Book
	Acetaminophen injection / acetaminophen mannitol injection	Acetaminophen Injection	50ml:500mg（10mg/ml）	B Braunmedical Inc	Original drugs have not been imported	American Orange Book
	Acetaminophen injection / acetaminophen mannitol injection	Acetaminophen Injection	100ml:1g（10mg/ml）	B Braunmedical Inc	Original drugs have not been imported	American Orange Book
	Gadoterol injection	Gadoteridol Injection /ProHance	279. 3mg/mL（1. 3965 g/5mL）	Bracco Diagnostics Inc	Original drugs have not been imported	American Orange Book
	Gadoterol injection	Gadoteridol Injection /ProHance	279. 3mg/mL（2. 793 g/10mL）	Bracco Diagnostics Inc	Original drugs have not been imported	American Orange Book
	Gadoterol injection	Gadoteridol Injection /ProHance	279. 3mg/mL（4. 1895 g/15mL）	Bracco Diagnostics Inc	Original drugs have not been imported	American Orange Book
	Gadoterol injection	Gadoteridol Injection /ProHance	279. 3mg/mL（5. 586 g/20mL）	Bracco Diagnostics Inc	Original drugs have not been imported	American Orange Book
	Gadoterol injection	Gadoteridol Injection /ProHance	279. 3mg/mL（13. 965 g/50mL）	Bracco Diagnostics Inc	Original drugs have not been imported	American Orange Book
	Amlodipine Benazepril capsules	Amlodipine besylate and benazepril hydrochloride capsules/Lotrel	Amlodipine 2. 5 mg; Benazepril hydrochloride 10 mg	Novartis Pharmaceuticals Corp.	Original drugs have not been imported	American Orange Book
	Guaicol glycerol ether sustained-release tablets	Guaifenesin extended-release bi-layer tablets/Mucinex	1200mg	RB HEALTH US LLC	Original drugs have not been imported	American Orange Book
	Gadolinium beglucosamine injection	Gadobenate Dimeglumine Injection/Multihance	5. 290GM/10ML（529MG/ML）	Bracco Diagnostics Inc.	Original drugs have not been imported	American Orange Book
1	Zinc ezetimibrovastatin capsules	Ezetimibe rosuvastatin zinc hard capsule/Cholecomb	5mg/10mg	Proterapia Hungary Ltd	Original drugs have not been imported	Listed in the EU
1	Zinc ezetimibrovastatin capsules	Ezetimibe rosuvastatin zinc hard capsule/Cholecomb	10mg/10mg	Proterapia Hungary Ltd	Original drugs have not been imported	Listed in the EU
1	Zinc ezetimibrovastatin capsules	Ezetimibe rosuvastatin zinc hard capsule/Cholecomb	20mg/10mg	Proterapia Hungary Ltd	Original drugs have not been imported	Listed in the EU
1	Aminovaleric acid hydrochloride gel	aminolevulinic acid hydrochloride gel/AMELUZ	78mg/g (in terms of aminovaleric acid)	Biofrontera Bioscience GmbH	Original drugs have not been imported	Listed in the EU
	Car-left didopa sustained-release tablets	Carbidopa and Levodopa Sustained-release Tablets/SINEMET LP	Carbidopa 25 mg, levodopa 100 mg	ORGANON FRANCE	Original drugs have not been imported	Listed in the EU
	Pitavastatin calcium tablets	Pitavastatin Calcium Tablets	1mg	Kowa Pharmaceutical Europe GmbH	Original drugs have not been imported	Listed in the EU
	Pitavastatin calcium tablets	Pitavastatin Calcium Tablets	2mg	Kowa Pharmaceutical Europe GmbH	Original drugs have not been imported	Listed in the EU
	Pitavastatin calcium tablets	Pitavastatin Calcium Tablets	4mg	Kowa Pharmaceutical Europe GmbH	Original drugs have not been imported	Listed in the EU
	Bisoprolol fumarate tablets	Bisoprolol Fumarate Tablets/Concor	5mg	Merck	Original drugs have not been imported	Listed in the EU
	Metoprolol succinate sustained-release tablets	Metoprolol Succinate Sustained-release Tablets	23. 75mg	Recordati Ireland Ltd	Original drugs have not been imported	Listed in the EU
	Metronidazole gel	Metronidazole Gel/Rozex/Metrogel	0. 75%	GALDERMA INTERNATIONAL/Galderma Laboratorium GmbH/Galderma(UK. ) Limited	Original drugs have not been imported	Listed in the EU
1	Pyrilaster potassium dry syrup	Pemirolast Potassium Dry Syrup/Alegysal	0. 50%	Tashima Mitsubishi Zoku Co. , Ltd	Original drugs have not been imported	Available in Japan
1	Zinc acetate tablets	Zinc Acetate Tablets/ノベルジン（NOBELZIN）	25mg	ノーベルファーマ (Nobel Pharma Co. , Ltd. )	Original drugs have not been imported	Available in Japan
1	Zinc acetate tablets	Zinc Acetate Tablets/ノベルジン（NOBELZIN）	50mg	ノーベルファーマ (Nobel Pharma Co. , Ltd. )	Original drugs have not been imported	Available in Japan
1	Iodine [123I] benzylguanidine injection	Iobenguane I123 Injection/ミオMIBG-I123 injection	111MBq/1. 5ml	PDRファーマ	Original drugs have not been imported	Available in Japan
1	Sodium bicarbonate Ringer injection (I. )	Sodium Bicarbonate Ringers Injection（Ⅰ）/BICARBON	500ml	エイワイファーマ	Original drugs have not been imported	Available in Japan
2	Povidone-iodine solution	Povidone Iodine solution	10%	ムンディファーマ	Original drugs have not been imported	Available in Japan
	Pioglitazone hydrochloride oral collapse	Pioglitazone Hydrochloride Orally Disintegrating Tablets/ACTOS OD	30mg (based on C19H20N2O3S)	Teva Takeda Yakuhin Ltd.	Original drugs have not been imported	Available in Japan
	Clindamycin phosphate injection	Clindamycin Phosphate Injection/Dalacin S	4mL:600mg	ファイザー	Original drugs have not been imported	Available in Japan
	Oxazepam tablets	Oxazepam Tablets/Sobril	15mg	Pfizer AS	Original drugs have not been imported	Available in Norway
	Esmolol hydrochloride sodium chloride injection	Esmolol Hydrochloride and Sodium Chloride Injection	50ml: Esmolol hydrochloride 1g with sodium chloride 0. 205g	Shanghai Baxter Medical Supplies Co. , Ltd	Drugs produced by foreign original research enterprises in China determined by audit	Original research real estate
42-25	Fluoxetine hydrochloride oral solution	Fluoxetine Hydrochloride Oral Solution/PROZAC	20mg/5ml	LILLY FRANCE/ELI LILLY ITALIA S. p. A.	Original drugs have not been imported	ADD LICENSEE ELI LILLY ITALIA S. p. a.
49-20	Trazodone hydrochloride sustained-release tablets	Trazodone Hydrochloride Sustained-release Tablets	75mg	Aziende Chimiche Riunite Angelini Francesco-A. C. R. A. F. S. p. A/Angelini Pharma eská Republika s. r. o.	Original drugs have not been imported	Increase licensee Angelini Pharma eská Republika s. r. o.
49-21	Trazodone hydrochloride sustained-release tablets	Trazodone Hydrochloride Sustained-release Tablets	150mg	Aziende Chimiche Riunite Angelini Francesco-A. C. R. A. F. S. p. A/Angelini Pharma eská Republika s. r. o.	Original drugs have not been imported	Increase licensee Angelini Pharma eská Republika s. r. o.
27-423	Levothyroxine sodium tablets	Levothyroxine Sodium Tablets/Euthyrox; Levothyrox	100 μg (in terms of levothyroxine sodium)	Merck Serono GmbH/Merck Sante/Merck GesellschaftmbH/Merck Healthcare Germany GmbH	Original drugs have not been imported	Increase licensee Merck Healthcare Germany GmbH
34-15	Bisoprolol fumarate tablets	Bisoprolol Fumarate Tablets/Concor	2. 5mg	Merck Serono GmbH/Merck Healthcare Germany GmbH	Original drugs have not been imported	Increase licensee Merck Healthcare Germany GmbH
38-35	Nimodipine oral solution	Nimodipine Oral Solution/Nymalize	6mg/ml	Arbor Pharmaceuticals, LLC/Azurity Pharmaceuticals Inc	Original drugs have not been imported	Licensee Azurity Pharmaceuticals Inc. was added
23-195	Propranolol hydrochloride injection	Propranolol Hydrochloride Injection/Inderal	2ml:2mg	ファルマ/アストラゼネカ	Original drugs have not been imported	Increase licensee: ファルマ
27-176	Amoxicillin sodium for injection, clavulanate potassium	Amoxicillin Sodium and Clavulanate Potassium for Injection/Augmentin/Levmentin	1000mg/200mg	Beechamgroup Ltd/Laboratoires Delbert	Original drugs have not been imported	Added the changed licensee Laboratoires Delbert and trade name Levmentin
28-9	Trientine hydrochloride tablets	Trientine Hydrochloride Tablets/Cuprior	150mg (in terms of C6H18N4)	GMP-Orphan SA/Orphalan	Original drugs have not been imported	Increase the licensee Orphalan
46-26	Clindamycin phosphate external solution	Clindamycin Phosphate Topical Solution	1%	Perrigo New York INC/PADAGIS US LLC	Internationally recognized homogeneous medicine	ADD LICENSEE PADAGIS US LLC
29-147	Oxaliplatin injection	Oxaliplatin Injection	200mg/40ml	Qilu Pharmaceutical Co Ltd / QILU PHARMACEUTICAL HAINAN CO LTD	Internationally recognized homogeneous medicine	ADDED THE CHANGED LICENSEE QILU PHARMACEUTICAL HAINAN CO LTD
8-239	Ferrous sulfate tablets	Ferrous Sulfate Tablets/Ferrous Sulfate	65mg (in terms of iron)	Actavis UK Ltd. /Accord-UK Ltd	Listed in the EU	Added the changed licensee Accord-UK Ltd
7-60	Dipyridamole tablets	Dipyridamole Tablets/Persantin	25mg	Medical Parkland Co. , Ltd. / Nippon Boehringer Ingelheim Co. , Ltd.	Japanese Orange Book	Additional licensee: Medical Parkland Co. , Ltd
34-11	Riprodiccaine cream	Lidocaine and Prilocaine Cream/Emla	1g: lidocaine 25 mg, propavacaine 25 mg	AstraZeneca AB/Aspen Pharmacare Australia Pty Ltd	Original drugs marketed in China	Added the changed licensee Aspen Pharmacare Australia Pty Ltd
8-159	Procaterol hydrochloride tablets	Procaterol Hydrochloride Tablets/Meptin-mini	25μg	OTSUKA PHARMACEUTICAL Co. , Ltd	Japanese Orange Book	Specifications made from 25μg (according to C16H22N2O3· HCl meter) revised to 25 μg
8-127	Temozolomide capsules	Temozolomide Capsules/--	20mg	Merck Sharp & Dohme Ltd/Merck Sharp & Dohme B. V.	Original research import	Added changed licensee Merck Sharp & Dohme B. V.
8-128	Temozolomide capsules	Temozolomide Capsules/--	0. 1g	Merck Sharp & Dohme Ltd/Merck Sharp & Dohme B. V.	Original research import	Added changed licensee Merck Sharp & Dohme B. V.
23-9	Dedrogesterone tablets	Dydrogesterone Tablets	10mg	Abbott Healthcare Products B. V. /Abbott B. V.	Original drugs marketed in China	Add the changed licensee Abbott B. V.
remark	1. The generic names, dosage forms, etc. of the varieties listed in the catalogue 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 catalog, the varieties that have not been officially released will be subject to special research and released separately according to the research results. 3. Reference preparations listed in the EU include the same drug listed in the UK. 4. In addition to meeting their quality requirements, the selection of unimported reference preparations for generic drug research must also meet the requirements of the current version of the Chinese Pharmacopoeia and relevant guidelines . 5. Radiopharmaceuticals are different from ordinary chemical drugs, with certain particularities such as radioactivity, timeliness, according to the characteristics of radioactive activity administration, etc. , reference preparations are mainly used to clarify their research and development goals and basic requirements, and can be studied according to their drug characteristics while combining the availability of reference preparations.

State Food and Drug Administration January 6, 2023

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