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The State Food and Drug Administration issued the 6th batch of reference preparations for generic drugs

 Last Update: 2022-10-25
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 Author: User

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After being reviewed and determined by the Expert Committee on the Evaluation of the Quality and Efficacy Consistency of Generic Drugs of the State Medical Products Administration, the 66th batch of reference preparations for generic drugs is hereby released
.

Notice is hereby given
.

Annex: Catalogue of Reference Preparations for Generic Drugs (61)

serial number	The generic name of the drug	English name/trade name	specification	Licensee	Note 1	Note 2
	Nocinaxen sodium injection	Nusinersen Sodium Injection	5ml: 12mg (according to Nocina livelihood)	Biogen Netherlands B. V.	Original drug listed in China	Original research import
	Malibavir tablets	Maribavir Tablets/LIVTENCITY	200mg	TAKEDA PHARMACEUTICALS USA INC	No original drugs have been imported	American Orange Book
	Varenicline tartrate nasal spray	varenicline tartrate nasal spray/TYRVAYA	0. 03mg/spray	Oyster Point Pharmac	No original drugs have been imported	American Orange Book
	Lidocaine ointment	Lidocaine Ointment /LIDOCAINE	5%	Fougera Pharmaceuticals Inc	No original drugs have been imported	American Orange Book
	Nicardipine hydrochloride glucose injection	Nicardipine Hydrochloride and Glucose Injection	200ml:20mg	Chiesi Usa Inc	No original drugs have been imported	American Orange Book
	Nicardipine hydrochloride sodium chloride injection	Nicardipine Hydrochloride and Sodium Chloride Injection	200ml:20mg	Chiesi Usa Inc	No original drugs have been imported	American Orange Book
	Ivabridine hydrochloride oral solution	Ivabradine Hydrochloride Oral Solution/Corlanor	5mg/5mL（1mg/mL）	Amgen Inc.	No original drugs have been imported	American Orange Book
	Urea [13C] tablets breath test kit	The Kit For [13C]-Urea Breath Test/IDKIT:HP	urea [13C] 75 mg; Citric acid 4 g	Exalenz Bioscience Ltd	No original drugs have been imported	American Orange Book
	Urea [14C] capsules	Urea C14Capsules/PYTEST	1μCi	AVENT INC	No original drugs have been imported	American Orange Book
	Sodium iodide [131I] oral solution	Sodium Iodide [131I] Oral Solution	250-1000mCi	Jubilant Draximage Inc Dba Jubilant Radiopharma	No original drugs have been imported	American Orange Book
	Sodium fluoride [18F] injection	SODIUM FLUORIDE F-18 Injection	10～200mCi/mL（0. 37～7. 40GBq/mL）	SOFIE Co. dba SOFIE	Internationally recognized as the same medicine	American Orange Book
	Diphenhydramine citrate ibuprofen tablets	Diphenhydramine Citrate andIbuprofen Tablets/ADVIL PM	Each tablet contains diphenhydramine citrate 38mg, ibuprofen 200mg	Glaxosmithkline Consumer Healthcare Holdings US LLC	No original drugs have been imported	American Orange Book
	Esketamine hydrochloride nasal spray	Esketamine hydrochloride nasal spray/SPRAVATO	0. 2 ml: 28 mg (in esketamine)	JANSSEN PHARMS	No original drugs have been imported	American Orange Book
	Topiramate solution for oral administration	Topiramate Oral Solution/Eprontia	25mg/ml	Azurity Pharmaceuticals, Inc.	No original drugs have been imported	American Orange Book
	Solution of glycopyrronium bromide for inhalation	Glycopyrrolate Inhalation Solution	1ml:25μg	Sunovion Respiratory Development, Inc.	No original drugs have been imported	American Orange Book
	Methylprednisolone acetate injection	Methylprednisolone acetate injection/DEPO-MEDROL	20mg/ml	Pfizer Inc	No original drugs have been imported	American Orange Book
	Methylprednisolone acetate injection	Methylprednisolone acetate injection/DEPO-MEDROL	40mg/ml	Pfizer Inc	No original drugs have been imported	American Orange Book
	Methylprednisolone acetate injection	Methylprednisolone acetate injection/DEPO-MEDROL	80mg/ml	Pfizer Inc	No original drugs have been imported	American Orange Book
	Dozolamide hydrochloride timolol maleate eye drops	Dorzolamide hydrochloride-timolol maleate ophthalmic solution/COSOPT PF	2% (dozolamide); 0. 5% (timolol), packing size 0. 2ml	THEA PHARMA INC	No original drugs have been imported	American Orange Book
	Miconazole nitrate cream	Miconazole Nitrate Cream/Daktarin	20mg/g	Johnson & Johnson Consumer NV/SA	No original drugs have been imported	EU listing
	Oxymetazoline hydrochloride spray	Oxymetazoline Hydrochloride Spray/Nasivin	0. 5mg/mL	P&G Health Germany GmbH	No original drugs have been imported	EU listing
	Oxymetazoline hydrochloride nasal drops	Oxymetazoline Hydrochloride Nasal Drops/Nasivin	0. 5mg/mL	P&G Health Germany GmbH	No original drugs have been imported	EU listing
	Iloprost injection	Iloprost Injection/Ilomedine； Ilomedin	50μg/0. 5ml	Bayer Austria GmbH/Bayer AB/BAYER HEALTHCARE/Bayer B. V. /Bayer Hispania, S. L. /Bayer Portugal/Bayer Vital GmbH/Bayer AG	No original drugs have been imported	EU listing
	Iloprost injection	Iloprost Injection/Ilomedine； Ilomedin	20μg/1ml	Bayer Austria GmbH/Bayer AB/BAYER HEALTHCARE/Bayer B. V. /Bayer Hispania, S. L. /Bayer Portugal/Bayer Vital GmbH/Bayer AG	No original drugs have been imported	EU listing
	Enalapril maleate loccidipine hydrochloride tablets	Enalapril/Lercanidipine film-coated tablets/ZANIPRESS	10mg/10mg	Recordati S. P. A.	No original drugs have been imported	EU listing
	Enalapril maleate loccidipine hydrochloride tablets	Enalapril/Lercanidipine film-coated tablets/ZANIPRESS	20mg/10mg	Recordati S. P. A.	No original drugs have been imported	EU listing
	Enalapril maleate loccidipine hydrochloride tablets	Enalapril/Lercanidipine film-coated tablets/ZANIPRESS	20mg/20mg	Recordati S. P. A.	No original drugs have been imported	EU listing
	Finasteride spray	Finasteride spray/CARETOPIC	2. 275mg/ml	Difa Cooper S. p. A	No original drugs have been imported	EU listing
	Lidocaine spray	Lidocaine Spray/Xylocaine	50ml: 5g, 10mg of lidocaine per spray, 500 sprays per bottle	Aspen Pharma Trading Limited	No original drugs have been imported	EU listing
	Compound polyethylene glycol (3350) electrolyte dispersion	MOVICOL 13. 8g sachet, powder for oral solution	13. 8g/bag, containing polyethylene glycol 3350 13. 125g; Sodium chloride 0. 3507g, sodium bicarbonate 0. 1785g, potassium chloride 0. 0466g	Norgine Limited	No original drugs have been imported	EU listing
	Compound electrolyte sodium acetate glucose injection	Multiple Electrolytes Sodium Acetate and Glucose Injection/Physio 35 Injection	250ml	Otsuka Pharmaceutical Co. , Ltd	No original drugs have been imported	Launched in Japan
	Compound electrolyte sodium acetate glucose injection	Multiple Electrolytes Sodium Acetate and Glucose Injection/Physio 35 Injection	500ml	Otsuka Pharmaceutical Co. , Ltd	No original drugs have been imported	Launched in Japan
	Urea cream	Urea Cream/Urepearl	10%	Otsuka Factory Co. , Ltd	No original drugs have been imported	Launched in Japan
	Anarelin hydrochloride tablets	Anamorelin Hydrochloride Tablets	50mg	Ono Wear Industry Co. , Ltd	No original drugs have been imported	Launched in Japan
	Irinotecan hydrochloride liposomal injection	Irinotecan Hydrochlorid Liposome injection/Onivyde, Ianda	10ml: 43mg (as C33H38N4O6)	Les Laboratoires Servier	Original drug listed in China	Original research import
	Omega-3 fatty acid ethyl ester 90 softgels	Omega-3-acid ethyl ester 90 Soft Capsules	1g (each capsule contains ethyl eicosapentaenoate 465mg, ethyl docosahexaenoate 375mg, total omega-3 fatty acid ethyl ester not less than 900mg)	ABBOTT LABORATORIES LIMITED	Original drug listed in China	Original research import
	Fosphenytoin sodium injection	Fosphenytoin Sodium Injection/Sesquient	50mg/ml（C15H11N2NaO2）（2ml、10ml）	LUPIN INC	No original drugs have been imported	American Orange Book
	Brimonidine tartrate eye drops	Brimonidine Tartrate Eye Drops/Alphagan P	0. 1%（5ml、10ml、15ml）	Allergan Inc	No original drugs have been imported	American Orange Book
	Valdenafil hydrochloride oral collapse tablets	Vardenafil Hydrochloride Orally disintegrating Tablets	10mg	Alembic Pharmaceuticals Inc.	Internationally recognized as the same medicine	American Orange Book
	Bumetanide injection	Bumetanide Injection/Burinex	2mg/4ml	Karo Pharma AB	No original drugs have been imported	EU listing
	Nicotine chewing gum	Nicotine Chewing Gum/Nicorette	2mg	McNeil Denmark ApS	No original drugs have been imported	EU listing
	Nicotine chewing gum	Nicotine Chewing Gum/Nicorette	4mg	McNeil Denmark ApS	No original drugs have been imported	EU listing
	Fluorouracil injection	Fluorouracil Injection	10ml:0. 5g	Hospira UK Limited	Internationally recognized as the same medicine	EU listing
	Irinotecan hydrochloride injection	Irinotecan Hydrochloride Injection/Campto	2mL:40mg	Pfizer Limited	No original drugs have been imported	EU listing
	Irinotecan hydrochloride injection	Irinotecan Hydrochloride Injection/Campto	15mL:0. 3g	Pfizer Limited	No original drugs have been imported	EU listing
	Irinotecan hydrochloride injection	Irinotecan Hydrochloride Injection/Campto	5mL:0. 1g	Pfizer Limited	No original drugs have been imported	EU listing
	Metronidazole gel	Metronidazole gel/Rozex	0. 75%	Galderma（UK. ） Limited	No original drugs have been imported	EU listing
	Saxagliptin tablets	Saxagliptin Tablets/Onglyza	2. 5mg	AstraZeneca AB	No original drugs have been imported	EU listing
	Saxagliptin tablets	Saxagliptin Tablets/Onglyza	5mg	AstraZeneca AB	No original drugs have been imported	EU listing
	Calcium levolinate injection	Calcium Levofolinate Injection/ELVORIN	10ml:100mg	PFIZER HOLDING FRANCE	No original drugs have been imported	EU listing
	Loccadipine hydrochloride tablets	Lercanidipine Hydrochloride Tablets/Zanidip	10mg	Recordati Industria Chimica e Farmaceutica S. p. A.	No original drugs have been imported	EU listing
	Concentrated solution of sodium valproate for injection	Sodium Valproate Concentrated Solution for Injection/Orfiril	4ml:0. 4g	Desitin Arzneimittel GmbH	No original drugs have been imported	EU listing
	Neutral peritoneal dialysate (lactate - G1. 5%)	Neutral Peritoneal Dialysis Solution (Lactate-G1. 5%)/ダイアニール-N PD-2 1. 5 peritoneal dialysis solution	1000ml, 1500ml, 2000ml, 2500ml, 5000ml/bag	バクスター	No original drugs have been imported	Launched in Japan
	Neutral peritoneal dialysate (lactate - G2. 5%)	Neutral Peritoneal Dialysis Solution (Lactate-G2. 5%)/ダイアニール-N PD-2 2. 5 Peritoneal Dialysate	1000ml, 1500ml, 2000ml, 2500ml, 5000ml/bag	バクスター	No original drugs have been imported	Launched in Japan
	Anhydrous betaine powder	Betaine anhydrous for oral solution/Cystadane	1g	レコルダティ・レア・ディジーズ・ジャパン	No original drugs have been imported	Launched in Japan
	Miglitol tablets	Miglitol Tablets/SEIBULE	50mg	Sanwa Chemical Research Institute Co. , Ltd	No original drugs have been imported	Launched in Japan
	Icodextrin peritoneal dialysate	Icodextrin Peritoneal Dialysis Solution	Contains 7. 5% ikodextrin (2000ml/bag).	Guangzhou Baxter Medical Supplies Co. , Ltd	Drugs produced in China by foreign original research enterprises determined by review	Original research real estate
7-68	Nifedipine sustained-release tablets	Nifedipine Sustained-release Tablets/Adalat retard	20mg	Bayer Vital GmbH/Bayer Hispania, S. L.	EU listing	Increase of licensee Bayer Hispania, S. L. , regardless of origin
8-86	Candesartan medoxomil tablets	Candesartan Cilexetil Tablets/Atacand	16mg	ASTRAZENECA PHARMACEUTICALS LP/ANI Pharmaceuticals, Inc.	No original drugs have been imported	Increase in licensee ANI Pharmaceuticals, Inc.
16-14	Lamivudine tablets	Lamivudine Tablets	0. 1g	GlaxoSmithKline Pharmaceuticals (Suzhou) Co. , Ltd. /Giske (Suzhou) Pharmaceutical Co. , Ltd	Original research real estate varieties	The licensee has been changed and the licensee Giske (Suzhou) Pharmaceutical Co. , Ltd. has been added
23-316	Compound amino acid injection (18AA-VII)	Compound Amino Acids Injection (188AA-VII)	200ml: 20. 650g (total amino acids)	Guangzhou Green Cross Pharmaceutical Co. , Ltd. / Guangzhou Green Cross Pharmaceutical Co. , Ltd	Drugs produced in China by foreign original research enterprises determined by review	The licensee has changed, and the changed licensee Guangzhou Green Cross Pharmaceutical Co. , Ltd. has been added
22-349	Doxorubicin hydrochloride liposomal injection	Doxorubicin Hydrochloride Liposome Injection/Caelyx	10ml:20mg	Janssen-Cilag International NV/Baxter Holding B. V	No original drugs have been imported	Licensee changes and adds Baxter Holding B. V
22-350	Doxorubicin hydrochloride liposomal injection	Doxorubicin Hydrochloride Liposome Injection/Caelyx	25ml:50mg	Janssen-Cilag International NV/Baxter Holding B. V	No original drugs have been imported	Licensee changes and adds Baxter Holding B. V
27-479	Mesobamo injection	Methocarbamol Injection/Robaxin	1g/10ml （100mg/ml）	Hikma Pharmaceuticals International Ltd/Hikma Pharmaceuticals Usa Inc	No original drugs have been imported	Licensee changes to include Hikma Pharmaceuticals Usa Inc
30-118	Pregabalin capsules	Pregabalin Capsules/Lyrica	100mg	Pfizer/Upjohn EESV	No original drugs have been imported	Increase in licensee Upjohn EESV
30-123	Irbesartan tablets	Irbesartan Tablets/Aprovel	75mg	Sanofi Clir SNC/Sanofi-aventis groupe	No original drugs have been imported	Increase in licensee Sanofi-aventis groupe
38-17	Amino acids (15) peritoneal dialysate	Amino Acids （15） Peritoneal Dialysis Solution	2. 0L	Baxter Healthcare Ltd. /Baxter S. p. A	No original drugs have been imported	Increase in the number of licensees, Baxter S. p. A
38-18	Amino acids (15) peritoneal dialysate	Amino Acids （15） Peritoneal Dialysis Solution	2. 5L	Baxter Healthcare Ltd. /Baxter S. p. A	No original drugs have been imported	Increase in the number of licensees, Baxter S. p. A
42-26	Triamcinolone acetonide econazole cream	Triamcinolone Acetonide and Econazole Nitrate Cream	Each gram contains econazole nitrate 10mg, triamcinolone acetonide 1. 0mg	Janssen-Cilag/Karo Pharma	No original drugs have been imported	Added licensee Karo Pharma
42-36	Paroxetine hydrochloride tablets	Paroxetine Hydrochloride Tablets	20mg (in terms of C19H20FNO3)	Sino-American Tianjin SmithKline Pharmaceutical Co. , Ltd. / GlaxoSmithKline (Tianjin) Co. , Ltd	Drugs produced in China by foreign original research enterprises determined by review	The licensee has been changed and the licensee has been added, GSK (Tianjin) Co. , Ltd
25-53	Etomidate medium/long-chain fat emulsion injection	Etomidate Medium and Long Chain Fat Emulsion Injection/Etomidate-Lipuro	10ml:20mg	B. Braun Melsungen AG	Original drug listed in China	The generic name of the drug was updated to etomidate medium/long-chain fat emulsion injection; The English name of the drug was updated to Etomidate Medium and Long Chain Fat Emulsion Injection
29-95	Procaterol hydrochloride solution for inhalation	Procaterol Hydrochloride Solution for Inhalation/Meptin	0. 5ml:50μg	Otsuka Manufacturing Co. , Ltd	No original drugs have been imported	The drug trade name was updated to Meptin
29-96	Procaterol hydrochloride solution for inhalation	Procaterol Hydrochloride Solution for Inhalation/Meptin	0. 3ml:30μg	Otsuka Manufacturing Co. , Ltd	No original drugs have been imported	The drug trade name was updated to Meptin
57-50	Ticagrelor tablets	Ticagrelor Tablets/Brilique	60mg	AstraZeneca AB	No original drugs have been imported	The drug trade name is updated to Brilique
57-51	Ticagrelor tablets	Ticagrelor Tablets/Brilique	90mg	AstraZeneca AB	No original drugs have been imported	The drug trade name is updated to Brilique
remark	1. The generic names, dosage forms, etc. of the varieties listed in the catalogue that have not yet been listed in China shall be subject to the approval of the Pharmacopoeia Commission. 2. After the catalog of reference preparations is publicized, 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. Reference preparations listed in the EU include the same drug products listed in the UK. 4. In addition to meeting its 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 guiding principles. 5. Different from ordinary chemical drugs, radiopharmaceuticals have certain particularities such as radioactivity, timeliness, and drug administration according to radioactive activity, and the reference preparation is mainly used to clarify its research and development goals and basic requirements, and can be studied according to its drug characteristics and the availability of the reference preparation.

NMPA

October 13, 2022

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