The State Food and Drug Administration released the catalog of generic drug reference preparations (43rd batch)

Serial number	Generic name of the drug	English name/trade name	Specification	Licensee	Remark 1	Remark 2
	Tacrolimus injection	Tacrolimus injection	1ml:5mg	Astellas Pharma Co. Ltd.	Original drugs marketed in China	Original research import
	Rifaximin Tablets	Rifaximin Tabiels/ Xifaxan	200mg	Alfasigma SpA	Original drugs marketed in China	Original research import
	Fat emulsion (20%) / amino acid (15) / glucose (30%) injection	Lipid Emulsion (20%)/Amino Acids (15) and Glucose (30%) Injection/ Clinomel	1000ml[fat emulsion injection (20%) 200ml; compound amino acid (8. 5%, 15AA) injection 400ml; glucose injection (30%) 400ml]	BAXTER SAS	Original drugs marketed in China	Original research import
	Fat emulsion (20%) / amino acid (15) / glucose (30%) injection	Lipid Emulsion (20%)/Amino Acids (15) and Glucose (30%) Injection/ Clinomel	1500ml[fat emulsion injection (20%) 300ml; compound amino acid (8. 5%, 15AA) injection 600ml; glucose injection (30%) 600ml]	BAXTER SAS	Original drugs marketed in China	Original research import
	Levothyroxine Sodium Oral Solution	Levothyroxine Sodium Oral Solution /Thyquidity	100µg/5ml	EMP LEVO US BV
		Clobazam Oral Suspension/ Onfi	2. 5mg/ml（120ml:300mg）	Lundbeck Pharmaceuticals LLC
		Estradiol Tablets	1mg	Barr Laboratories Inc
		Proparacaine Hydrochloride Eye Drops	0. 5%（15ml）	Akorn Inc
		Famotidine and Sodium Chloride Injection	0. 4mg/ml	Baxter Healthcare Corpration
		Calcitriol Oral Solution	15ml:15μg	Validus Pharmaceuticals LLC
		Colchicine Oral Solution/ Gloperba	0. 6mg/5ml	Avion Pharmaceuticals LLC
		Sildenafil Sitrate For Oral Suspension	10mg/mL	Upjohn EESV
		Methotrexate Disodium Solution For Injection In Pre-Filled Syringe/Metoject、Metex	50mg/ml	medac Gesellschaft für klinische Spezialpräparate mbH
		Enzalutamide Tablets	80mg	アステラス
		Ketoprofen Cataplasms	30mg,10cm×14cm
		Tizanidine Hydrochloride Granules / Ternelin	0. 2% (1g granules containing 2mg tizanidine)	Sunfame Co. , Ltd.	No imported original research drugs	Listed in Japan
	Domifene lozenges	Domiphen bromide Buccal Tablets/Oradol	0. 5mg	Takeda Technology Co. , Ltd.	No imported original research drugs	Listed in Japan
	Sodium picosulfate tablets	Sodium Picosulfate Tablets/ ラキソベロン Tablet 2. 5mg	2. 5mg	Teijin Fame Co. , Ltd.	No imported original research drugs	Listed in Japan
	Ketoconazole Cream	Ketoconazole Cream	2%, 30g/piece	Janssen-Cilag Ltd	No imported original research drugs	UK listed
	Levosimendan Injection	Levosimendan Injection	5ml:12. 5mg	Orion Corporation	Original drugs marketed in China	Original research import
	Esmolol Hydrochloride and Sodium Chloride Injection	Esmolol Hydrochloride and Sodium Chloride Injection	100ml: 2g esmolol hydrochloride and 0. 41g sodium chloride	Shanghai Baxter Medical Products Co. , Ltd.	Drugs produced in China by foreign original research companies that have been reviewed and determined	Original research real estate
	Gadolinium meglumine injection	Gadobenate Dimeglumine Injection	10. 58GM/20ML (529MG/ML)	Bracco Diagnostics Inc.	No imported original research drugs	American Orange Book
	Dexrazoxane for injection	Dexrazoxane for Injection/Totect	500mg	Clinigen, Inc.	No imported original research drugs	American Orange Book
	Lenalidomide capsules	Lenalidomide Capsules/Revlimid	10mg	Celgene Corporation	No imported original research drugs	American Orange Book
	Lenalidomide capsules	Lenalidomide Capsules/Revlimid	25mg	Celgene Corporation	No imported original research drugs	American Orange Book
	Efavirenz Lamivudine Tenofovir Tablets	Efavirenz Lamivudine and tenofovir Disoproxil Fumarate Tablets/Symfi	Each tablet contains efavirenz 600mg, lamivudine 300mg and tenofovir disoproxil fumarate 300mg	Mylan Laboratories Ltd	No imported original research drugs	American Orange Book
	Potassium chloride oral solution	Potassium Chloride Oral Solution	20mEq/15ml (473ml)	Genus Life Sciences Inc	No imported original research drugs	American Orange Book
	Ramipril tablets	Ramipril Tablets/ Tritace	2. 5mg	Sanofi Belgium	No imported original research drugs	EU listing
	Ramipril tablets	Ramipril Tablets/ Tritace	5mg	Sanofi Belgium	No imported original research drugs	EU listing
	Amorolfine Hydrochloride Liniment	Amorolfine Hydrochloride Liniment	0. 05%	Galderma International	No imported original research drugs	EU listing
	Various oil and fat emulsion injections (C6～24)	Multi-Oil Fat Emulsion Injection (C6～24)	1000 ml	Fresenius Kabi AB	No imported original research drugs	EU listing
	Various oil and fat emulsion injections (C6～24)	Multi-Oil Fat Emulsion Injection (C6～24)	500 ml	Fresenius Kabi AB	No imported original research drugs	EU listing
	Various oil and fat emulsion injections (C6～24)	Multi-Oil Fat Emulsion Injection (C6～24)	250 ml	Fresenius Kabi AB	No imported original research drugs	EU listing
	Various oil and fat emulsion injections (C6～24)	Multi-Oil Fat Emulsion Injection (C6～24)	100 ml	Fresenius Kabi AB	No imported original research drugs	EU listing
	Aminolevulinic acid hexyl ester hydrochloride and special solvent for bladder perfusion	Hexaminolevulinate Hydrochloride Powder And Solvent For Intravesical Solution/Hexvix	85mg	Ipsen Pharma Gmbh	No imported original research drugs	EU listing
	Diquafosol Sodium Eye Drops	Diquafosol Sodium Eye Drops/Diquas	3% (5ml:150mg)	Santen Pharmaceutical Co. , Ltd.	No imported original research drugs	Listed in Japan
	Sucralfate Oral Suspension	Sucralfate Oral Suspension /Ulcerlmin	10ml:1g(10%)	Fuji Chemical Industry Co. , Ltd.	Unimported original research drugs	Listed in Japan
	Sodium picosulfate oral solution	Sodium Picosulfate Oral Solution/Laxoberon	7. 5mg/ml	Sanofi	No imported original research drugs	Listed in Japan
	Clobazam tablets	Clobazam Tablets/Frisium	10mg	Aventis Pharma Ltd	No imported original research drugs	UK listed
10-86	Riluzole tablets	Riluzole Tablets/RILUTEK	50mg	Aventis Pharma SA /Sanofi Mature IP	Original research import	The license holder has changed, and the license holder Sanofi Mature IP is added after the change
10-106	Midazolam Maleate Tablets	Midazolam Maleate Tablets/Dormicum	15mg (calculated as C18H13C1FN3)	Roche Pharma (Schweiz) Ltd. /Roche Pharma (Schweiz) AG/CHEPLAPHARM Arzneimittel GmbH	Original research import	The license holder has changed and the license holder Roche Pharma (Schweiz) AG/CHEPLAPHARM Arzneimittel GmbH has been added after the change.
16-12	Albendazole Tablets	Albendazole Tablets/Shi Ke Chang Chong Qing	0. 2g	Sino-U. S. Tianjin SmithKline Pharmaceutical Co. , Ltd.	Original research and localized varieties	The errata of the licensee is Sino-U. S. Tianjin SmithKline Pharmaceutical Co. , Ltd.
21-40	Concentrated zoledronic acid solution for injection	Zoledronic Acid Concentrated Solution for Injection/Zometa	5ml: 4mg	Novartis Pharma Schweiz AG /Future Health Pharma GmbH	Original drugs marketed in China	The license holder has changed, and the license holder Future Health Pharma GmbH will be added after the change.
Remark	1. The generic names and dosage forms of the varieties listed in the catalogue that have not yet been marketed in China shall be subject to those approved by 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 based on the research results . 3. The reference preparations marketed in the EU include the same drugs marketed in the UK . 4. Selecting non-imported reference preparations to carry out generic drug research should not only meet its quality requirements, but also meet the requirements of the current version of the Chinese Pharmacopoeia and related guidelines .

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.  

 

1.  

1.  

1.