NMPA Approves 145 New Drug Registrations Including Over 60 Products and 26 Generic Consistency Evaluations

Oct 31, 2023 16:32 CST Updated 16:32

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Just now, NMPA released the drug approval certificate delivery information on October 31, 2023.This batch has 145 approval numbers granted, of which 26 are for consistency evaluation., including the following approved varieties:

Beijing SL Pharmaceutical Co., Ltd., Paclitaxel Injection

Qilu Pharmaceutical (Hainan) Co., Ltd., Oxaliplatin for Injection

Shijiazhuang No.4 Pharmaceutical Co.,Ltd., Metoprolol Tartrate Injection

Qilu Pharmaceutical Co., Ltd., Azithromycin for Injection

Shenzhen Salubris Pharmaceuticals, Yuelong Pharmaceuticals, Chengdu Bright Future Pharmaceutical, Cefotaxime Sodium for Injection

etc.

This time, 96 additional marketing application acceptance numbers have been approved., including the following listed varieties:

Yangtze River PharmaceuticalBicalutamide Tablets；Qilu Pharmaceutical (Hainan) Co., Ltd.Sacubitril Valsartan Sodium Tablets; Yantai Luyin PharmaceuticalPitavastatin Calcium Tablets; China Resources Sanjiu PharmaceuticalArginine Ibuprofen Granules、Oseltamivir Phosphate Capsules; Jiangsu Hansoh PharmaceuticalTedizolid Phosphate for Injection; Yantai Dongcheng Northern PharmaceuticalDalteparin Sodium Injection; Chongqing Yaoyou Pharmaceutical Co., Ltd.Rabeprazole Sodium Enteric-Coated Tablets; Yichang Humanwell Pharmaceutical Co., Ltd.Nalbuphine Hydrochloride Injectionetc.

In addition,Anhui Ankang Biotechnology Engineering's Trastuzumab for Injection Approved for Marketing。

Luye Pharma's Risperidone Transdermal Patch (2 times/W) Approved for Marketing in China。

Pfizer's Sugrelimab Injection Third Indication Granted Conditional Approval for Marketing，Monotherapy for the treatment of adult patients with relapsed or refractory extranodal NK/T-cell lymphoma (R/R ENKTL).

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