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NMPA Releases Catalogue of Reference Preparations for Generic Drugs (62nd Batch)

 Last Update: 2023-02-03
 Source: Internet
 Author: User

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After the review and determination of the Expert Committee for Quality and Efficacy Consistency Evaluation of Generic Drugs of the State Medical Products Administration, the catalogue of reference preparations for generic drugs (the 62nd batch)
is hereby released.
Notice is hereby given
.
Annex: Generic Reference Preparations Catalogue (62nd Batch)

serial number	Generic name of the drug	English name/trade name	specification	Licensees	Note 1	Note 2
	Bosentan dispersible tablets	Bosentan Dispersible Tablets/Tracleer	32mg	Actelion Pharmaceuticals Ltd	Original drugs marketed in China	Original research import
	Sinimod tablets	Siponimod Tablets/Mayzent	0. 25mg (based on C58H70F6N4O6)	Novartis Pharma Ag/Novartis Pharma Schweiz AG	Original drugs marketed in China	Original research import
	Sinimod tablets	Siponimod Tablets/Mayzent	2mg (based on C58H70F6N4O6)	Novartis Pharma Ag/Novartis Pharma Schweiz AG	Original drugs marketed in China	Original research import
	Darolutamide tablets	Darolutamide Tablets/Nubeqa	300mg	Bayer Healthcare Pharmaceuticals Inc.	Original drugs marketed in China	Original research import
	Compound electrolyte injection	Multiple Electrolytes Injection	500ml	Shanghai Baxter Medical Supplies Co. , Ltd	Drugs produced by foreign original research enterprises in China determined by audit	Original research real estate
	Dorzolamide timolol maleate eye drops	Dorzolamide Hydrochloride Timolol Maleate Eye Drops /Cosopt	Contains dorzolamide 20mg/ml (2. 0%) and timolol 5mg/ml (0. 5%)	Thea Pharma Inc	Original research products are not imported	American Orange Book
	Technetium [99mTc] pentinate injection	Technetium[99mtc] Pentetate Injection / Draximage Dtpa	N/A	Jubilant Draximage Inc Dba Jubilant Radiopharma	Original drugs have not been imported	American Orange Book
	Technetium [99mTc]methylenediphosphonate injection	Technetium[99mtc] Methylenediphosphonate Injection / Draximage Mdp-25	N/A	Jubilant Draximage Inc Dba Jubilant Radiopharma	Original drugs have not been imported	American Orange Book
	Technetium [99mTc] methoxyisonitrile injection	Technetium[99mtc] Sestamibi Injection / Cardiolite	N/A	Lantheus Medical Imaging Inc	Original drugs have not been imported	American Orange Book
	Angiotensin II injection	Angiotensin II Injection/Giapreza	2. 5mg/mL	La Jolla Pharma Llc	Original drugs have not been imported	American Orange Book
	Sirolimus for injection (albumin-bound type)	Sirolimus Protein-Bound Particles For Injectable Suspension （Albumin-Bound）/Fyarro	100mg	Aadi Bioscience Inc.	Original drugs have not been imported	American Orange Book
	Belinstim for injection	Belinostat For Injection/ Beleodaq	500mg/Vial	Spectrum Pharmaceuticals,Inc. /Acrotech Biopharma Llc	Original drugs have not been imported	American Orange Book
	Omeprazole magnesium/amoxicillin/rifabutine enteric-coated capsules	Amoxicillin;Omeprazole Magnesium; Rifabutin Enteric Capsules/Talicia	Omeprazole magnesium (equivalent to omeprazole 10 mg), amoxicillin 250 mg, rifabutine 12. 5 mg	Redhill Biopharma Ltd.	Original drugs have not been imported	American Orange Book
	Nitazoxanide dry suspension	Nitazoxanide For Oral Suspension/Alinia	100mg/5ml	Romark Laboratories	Original drugs have not been imported	American Orange Book
	Compound electrolyte injection	Multiple Electrolytes Injection, Type 1/ Plasma-Lyte A Injection PH7. 4	500ml、1000ml	Baxter Healthcare Corporation	Original drugs have not been imported	American Orange Book
	Veroxazine hydrochloride sustained-release capsules	Viloxazine Hydrochloride Extended-Release Capsules / Qelbree	100mg	Supernus Pharmaceuticals	Original drugs have not been imported	American Orange Book
	Veroxazine hydrochloride sustained-release capsules	Viloxazine Hydrochloride Extended-Release Capsules / Qelbree	150mg	Supernus Pharmaceuticals	Original drugs have not been imported	American Orange Book
	Veroxazine hydrochloride sustained-release capsules	Viloxazine Hydrochloride Extended-Release Capsules / Qelbree	200mg	Supernus Pharmaceuticals	Original drugs have not been imported	American Orange Book
	Alendronate sodium oral solution	Alendronate Sodium Tablets Solution	EQ 70MG base /75ML	Hikma Pharmaceuticals Usa Inc	Internationally recognized homogeneous medicine	American Orange Book
	Lidocaine ointment	Lidocaine Ointment/ Xylocaine	5%	Aspen Pharma Trading Limited	Original drugs have not been imported	Listed in the EU
	Benzometronidazole oral suspension	Metronidazole Benzoateoral Suspension / Flagyl	125 mg metronidazole / 5 ml (equivalent to 200 mg benzoyl metronidazole / 5 ml)	Sanofi-Aventis, S. A.	Original drugs have not been imported	Listed in the EU
	Miconazole nitrate vaginal cream	Miconazole Nitrate Vaginal Cream	2%	Janssen/Johnson & Johnson	Original drugs have not been imported	Listed in the EU
	Sodium technetium [99mTc] acid injection	Sodium Pertechnetate [99mtc] Injection / ウルトラテクネカウ	0. 925, 1. 85, 2. 78, 3. 70, 4. 63, 5. 55, 7. 40, 11. 1, 14. 8, 18. 5GBq (99Mo-99mTc generator)	Fuji フイルムToyama Chemical Co. , Ltd. / PDRファーマ	Original drugs have not been imported	Available in Japan
	Vitamin D oral solution	Vitamin D Oral Solution/Uvedose	2ml: 2. 5mg (100,000)	Laboratoires Crinex	Original drugs have not been imported	Available in France
	Multiple trace element injection (III)	Multi-Trace Elements Injection (III)	10ml	Fresenius Kabi Norge AS	Original drugs marketed in China	Original research import
	Etebant acetate injection	Icatibant Acetate Injection	3ml: 30mg (based on C59H89N19O13S)	Shire Pharmaceuticals Ireland Limited	The original research drug on the domestic market	Original research import
	Rivaroxaban dry suspension	Rivaroxaban Granules For Oral Suspension/ Xarelto	51. 7mg	Bayer AG	Original drugs marketed in China	Original research import
	Rivaroxaban dry suspension	Rivaroxaban Granules For Oral Suspension/ Xarelto	103. 4mg	Bayer AG	Original drugs marketed in China	Original research import
	Cyclosporine eye drops (III)	Ciclosporin Eye Drops(III)	0. 3ml:0. 3mg (0. 1%)	Santen Oy	Original drugs marketed in China	Original research import
	Cilostazol tablets	Cilostazol Tablets/Peida	50mg	Zhejiang Otsuka Pharmaceutical Co. , Ltd	Drugs produced by foreign original research enterprises in China determined by audit	Original research real estate
	Alanyl glutamine injection	Alanyl Glutamine Injection	100ml:20g	Fresenius Kabi Warey Pharmaceutical Co. , Ltd	Drugs produced by foreign original research enterprises in China determined by audit	Original research real estate
	Olopatadine hydrochloride eye drops	Olopatadine Hydrochloride Ophthalmic Solution/Pataday	0. 1%（5ml:5mg）	Alcon Laboratories Inc	Original drugs have not been imported	American Orange Book
	Low-calcium peritoneal dialysate (lactate)	Low Magnesium, Low Calcium Peritoneal Dialysis Solution	With 4. 25% Glucose (2L/bag, 5L/bag)	Fresenius Medical Care North America	Original drugs have not been imported	American Orange Book
	Low-calcium peritoneal dialysate (lactate)	Low Magnesium, Low Calcium Peritoneal Dialysis Solution	With 2. 5% Glucose (2L/bag, 5L/bag)	Fresenius Medical Care North America	Original drugs have not been imported	American Orange Book
	Low-calcium peritoneal dialysate (lactate)	Low Magnesium, Low Calcium Peritoneal Dialysis Solution	With 1. 5% Glucose (2L/bag, 5L/bag)	Fresenius Medical Care North America	Original drugs have not been imported	American Orange Book
	Tiotropium bromide powder inhaler	Tiotropium Bromide Powder For Inhalation/Spiriva	18 ΜG (ACCORDING TO TIOTROPIUM, EQUIVALENT TO 22. 5 ΜG OF TIOTROPIUM BROMIDE MONOHYDRATE)	Boehringer Ingelheim International Gmbh	Original drugs have not been imported	American Orange Book
	Methylene blue injection	Methylthionine Chloride Injection/ Provayblue	50mg/10ml（5mg/ml）	Provepharm SAS	Original drugs have not been imported	American Orange Book
	Paliperidone sustained-release tablets	Paliperidone Extend-Release Tablets	9mg	Janssen Pharmaceuticals, Inc.	Original drugs have not been imported	American Orange Book
	Bemeiprost eye drops	Bimatoprost Eye Drops/Lumigan	0. 01%	Allergan Inc.	Original drugs have not been imported	American Orange Book
	Acetazolamide sustained-release capsules	Acetazolamide Extended-Release Capsules	500mg	Cadila Healthcare Limited	Internationally recognized homogeneous medicine	American Orange Book
	Budesonide formoterol inhalation powder nebult (I)	Budesonide And Formoterol Fumarate Powder For Inhalation (I) / Symbicort Mite Turbuhaler	Each vial contains 60 μg of budesonide and 4. 5 μg of formoterol fumarate	Astrazeneca AB	Original drugs have not been imported	Listed in the EU
	Budesonide formoterol inhalation powder nebul (II)	Budesonide And Formoterol Fumarate Powder For Inhalation (II) / Symbicort Turbuhaler	Each vial contains 60 μg of budesonide and 4. 5 μg of formoterol fumarate	Astrazeneca AB	Original drugs have not been imported	Listed in the EU
	Budesonide formoterol inhalation powder nebul (II)	Budesonide And Formoterol Fumarate Powder For Inhalation (II) / Symbicort Turbuhaler	Each 120 pipes contain budesonide 160 μg and formoterol fumarate 4. 5 μg	Astrazeneca AB	Original drugs have not been imported	Listed in the EU
	Budesonide formoterol inhalation powder nebul (II)	Budesonide And Formoterol Fumarate Powder For Inhalation (II) / Symbicort Forte Turbuhaler	Each 60 suction, each inhalation contains budesonide 320 μg and formoterol fumarate 9 μg	Astrazeneca AB	Original drugs have not been imported	Listed in the EU
	Cetirizine hydrochloride drops	Cetirizine Dihydrochloride Oral Drops	10mg/ml（20ml）	UCB Pharma	Original drugs have not been imported	Listed in the EU
	Clarithromycin sustained-release tablets	Clarithromycin Modified-Release Tablets / Klacid SR）/ Klacid RM/ KLACID UNIDÍA/ Klacid SR/ Klacid Uno/ Klacid LA/ Klacid SR/ Biclar Uno/ Klacid XL	500mg	Mylan Healthcare B. V. / Mylan Italia S. R. L. / Mylan IRE Healthcare Limited/ MYLAN HEALTHCARE Gmbh/ Mylan Healthcare Sp. Z O. O. / Mylan IRE Healthcare Limited/ Mylan EPD Bvba/Sprl/ Mylan IRE Healthcare Limited	Original drugs have not been imported	Listed in the EU
	Miconazole nitrate cream	Miconazole Nitrate Cream	2%	Janssen/Johnson & Johnson	Original drugs have not been imported	Listed in the EU
	Sildenafil citrate injection	Sildenafil Citrate Injection/Revatio	12. 5ml: 10mg (in terms of sildenafil)	Upjohn EESV	Original drugs have not been imported	Listed in the EU
	Landiolol hydrochloride for injection	Landiolol Hydrochloride For Injection/onoact	12. 5 mg (in terms of landiolol hydrochloride)	Ono Sasa Industrial Co. , Ltd	Original drugs have not been imported	Available in Japan
	Landiolol hydrochloride for injection	Landiolol Hydrochloride For Injection/onoact	150 mg (in terms of landiolol hydrochloride)	Ono Sasa Industrial Co. , Ltd	Original drugs have not been imported	Available in Japan
	Mitiglinide calcium tablets	Mitiglinide Calcium Tablets/Glufast	5mg	Kissei Pharmaceutical Co. , Ltd. /キッセイ Co. , Ltd	Original drugs have not been imported	Available in Japan
	Polyethylene glycol sodium potassium powder/compound polyethylene glycol (3350) electrolyte dispersion	MOVICOL Chocolate 13. 9g Sachet, Powder For Oral Solution/ MOVICOL	13. 9g	Norgine Limited	Original drugs have not been imported	Available in the UK
	Acetylcysteine injection	Acetylcysteine Injection/Flumil /Fluimucil	3ml:300mg	Zambon S. A. U /Zambon Gmbh	Original drugs have not been imported	Listed in the EU
	Aspartate pasireotide injection	Pasireotide Diaspeartate Injection	1ml:0. 6mg	Recordati AG	Original drugs have not been imported	Available in Switzerland
	Ursodeoxycholic acid tablets	Ursodeoxycholic Acid Tablets/ Delursan	0. 25g	TEVA B. V.	Original drugs have not been imported	Available in France
4-16	Ibuprofen softgels	Ibuprofen Soft Capsules/Advil	0. 2g	Pfizer Inc/ Glaxosmithkline Consumer Healthcare Holdings Us Llc	American Orange Book	Increase licensee Glaxosmithkline Consumer Healthcare Holdings Us Llc
7-64	Lithium carbonate sheets	Lithium Carbonate Tablets/TERALITHE	0. 25g	SANOFI-AVENTIS France	Original drugs have not been imported	There is no restriction on the country of listing and the place of origin
8-71	Pentoxifylline sustained-release tablets	Pentoxifylline Modified Release Tablets/Trental	400mg	Aventis Pharma Limited/Sanofi/Sanofi-Produtos Farmaceuticos Lda	Listed in the EU	Increase licensee Sanofi-Produtos Farmaceuticos LDA
23-349	Doxorubicin hydrochloride liposomal injection	Doxorubicin Hydrochloride Liposome Injection/Caelyx /Caelyx Pegylated Liposomal	10ml:20mg	Janssen-Cilag International NV /Baxter Holding B. V.	Original drugs have not been imported	Add licensee Baxter Holding B. V. ; add trade name Caelyx Pegylated Liposomal
23-350	Doxorubicin hydrochloride liposomal injection	Doxorubicin Hydrochloride Liposome Injection/Caelyx /Caelyx Pegylated Liposomal	25ml:50mg	Janssen-Cilag International NV /Baxter Holding B. V.	Original drugs have not been imported	Add licensee Baxter Holding B. V. ; add trade name Caelyx Pegylated Liposomal
53-71	Trizidone capsules	Terizidon Capsules	250mg	Riemser Pharma Gmbh/Esteve Pharmaceuticals Gmbh	Internationally recognized homogeneous medicine	The licensee was changed and the changed licensee, Esteve Pharmaceuticals Gmbh, was added
56-62	Adapalene peroxybenzoyl gel	Adapalene And Benzoyl Peroxide Gel/Epiduo	0. 1%; 2. 5% (Packing: 5g, 15g, 30g, 45g, 60g, 90g/tube and 15g, 30g, 45g, 60g/pump)	Galderma Nordic AB/ Galderma International S. A. S/ Galderma International/ Galderma Benelux B. V. / Galderma Laboratorium Gmbh/ Laboratorios Galderma S. A. / Galderma Italia S. P. A. / Galderma ( UK) Limited	Original drugs have not been imported	Increase of licensee Galderma International S. A. S/ Galderma International/ Galderma Benelux B. V. / Galderma Laboratorium Gmbh/ Laboratorios Galderma S. A. / Galderma Italia S. P. A. / Galderma (UK) Limited
8-218	Tadalafil tablets	Tadalafil Tablets/Cialis	5mg	Eli Lilly Nederland B. V. /A. Menarini GmbH	Original research import	Change of licensee, add the change of licensee A. Menarini GmbH
16-4	Tadalafil tablets	Tadalafil Tablets/CIALIS	20mg	Eli Lilly Nederland B. V. /A. Menarini GmbH	Original research import	Change of licensee, add the change of licensee A. Menarini GmbH
16-5	Tadalafil tablets	Tadalafil Tablets/CIALIS	10mg	Eli Lilly Nederland B. V. /A. Menarini GmbH	Original research import	Change of licensee, add the change of licensee A. Menarini GmbH
16-6	Tadalafil tablets	Tadalafil Tablets/CIALIS	2. 5mg	Eli Lilly Nederland B. V. /A. Menarini GmbH	Original research import	Change of licensee, add the change of licensee A. Menarini GmbH
22-228	Mephalan hydrochloride for injection	Melphalan Hydrochloride for Injection/EVOMELA	50mg	Spectrum Pharmaceuticals, Inc. / Acrotech Biopharma,LLC	Original drugs marketed in China	Change of licensee, addition of post-change licensee Acrotech Biopharma, LLC
23-67	Imidzolastine sustained-release tablets	Mizolastine Sustained Release Tablets / Mizollen	10mg	Therabel Pharmaceuticals Limited/ Therabel Healthcare Limited	Original drugs marketed in China	Change of licensee, add the changed licensee Therabel Healthcare Limited
24-62	Nttacapone tablets	Entacapone Tablets/Comtan	0. 2g	Orion Pharma AG/Orion Corporation	Original drugs marketed in China	Change of licensee, addition of changed licensee Orion Corporation
27-426	Amlodipine Benazepril capsules	Amlodipine and Benazepril Hydrochloride Capsules/Lotrel	Amlodipine 5 mg; Benazepril hydrochloride 10 mg	Novartis Pharmaceuticals Corp	Original drugs have not been imported	The English name was updated to Amlodipine and Benazepril Hydrochloride Capsules
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 December 19, 2022

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