Circular of the General Administration of the people's Republic of China on the issuance of the catalogue of generic reference preparations (the second batch)

According to the review and determination of the Expert Committee on the conformity evaluation of quality and efficacy of generic drugs by the State Food and drug administration, the catalogue of generic reference preparations (the second batch) is hereby issued Notice is hereby given Appendix: Catalogue of generic reference preparations (the second batch) appendix to Circular No 46 of the food and Drug Administration of the people's Republic of China on March 20, 2017 Doc appendix catalogue of generic reference preparations (the second batch) No generic name of drugs English name /Trade name, specification, dosage form, holder's remark 1, remark 2 2-1 Amiodarone hydrochloride tablets / ancaron 0.1g tablet Sanofi K.K Japanese orange peel book 2-2 Acarbose Tablets / globe 0.1g tablet Bayer vital GmbH Cefuroxime axetil tablets / ceftin, imported 2-3 cefuroxime ester tablets, 0.5g as per cefuroxime (c16h16n4o8s) Tablet GlaxoSmithKline American orange peel Book 2-4 cefuroxime ester dry suspension Cefuroxime axetil for suspension / Zinnat 0.125g oral suspension (dry suspension) GlaxoSmithKline according to cefuroxime (c16h16n4o8s), S A EU listing (origin: UK; listing country: Spain) 2-5 simvastatin tablets / Zocor 5mg tablet Merck sharp & Dohme (Australia) Pty Ltd originally imported 2-6 Simvastatin tablets / Zocor 40mg tablet Merck sharp & Dohme (Australia) Pty Ltd 2-7 ambroxol hydrochloride tablets / Mucosolvan 60mg tablets Boehringer Ingelheim Pharma GmbH & Co kg is listed in European Union (origin: France; listed country: Germany) ambroxol 2-8 sustained release capsule of ambroxol hydrochloride Hydrochloride sustained release capsules / Mucosolvan 75mg capsule (sustained release capsule) Boehringer Ingelheim Pharma GmbH & Co.KG 2-9 quetiapine fumarate tablets / seroquel 0.2g tablet AstraZeneca UK Limited Quetiapine fumarate tablets / seroquel 0.3g Tablet AstraZeneca UK Limited originally imported 2-11 quetiapine fumarate tablets Quetiapine fumarate tablets / seroquel 50mg tablet AstraZeneca pharmaceuticals LP American Orange Book Medroxyprogesterone acetate tablets / Provera 10mg tablets Pharmacia and Upjohn Co Medroxyprogesterone acetate tablets / farlutal 0.5g Tablet Pfizer Italia S.r.l originally imported 2-14 amoxicillin and clavulanate potassium dry suspension Amoxicillin and clavulanate potassium for suspension / Augustin 0.15625g (c16h19n3o5s 0.125g and c8h9no5 0.03125g) oral suspension (dry suspension) Beecham Group PLC Listing in EU (listing country: UK; origin: UK) amoxicillin and clavulanate potassium for suspension / Augustin 0.3125g (c16h19n3o5s 0.25g and c8h9no5 0.0625g) oral suspension (dry suspension) Beecham Group PLC is listed in European Union (listing country: UK; origin: UK) Amoxicillin and clavulanate potassium for suspension / Augustin 0.2285g (c16h19n3o5s 0.2g and c8h9no5 0.0285g) Oral suspension (dry suspension) SmithKline Beecham limited original research import 2-17 Clopidogrel Hydrogen Sulfate Tablets / Plavix 300mg Sanofi CLIR SNC Clarithromycin sustained release tablets / klacid SR 0.5g tablets (sustained release tablets) Abbott Laboratories (Singapore) private limited imported clarithromycin for 2-19 Suspension / klacid 0.125g oral suspension (dry suspension) Abbott Laboratories (Singapore) Private Limited 2-20 clarithromycin dry suspension