Recently, Sinopharm Group Weqida Pharmaceutical Co., Ltd. ("Weqida Pharmaceutical"), a wholly-owned subsidiary of Shanghai Modern Pharmaceutical Co., Ltd. (the "Company"), has received the Approval Notice for Marketing Authorization Application of Chemical Active Pharmaceutical Ingredient (API) verified and issued by the National Medical Products Administration (NMPA). The application for the marketing of the API Ampicillin has been approved. Relevant details are hereby announced as follows:
I. Basic Information of the Chemical API
Name of Chemical API: Ampicillin
Registration Number: Y20230000630
Registration Standard Number of Chemical API: YBY75852024
Packaging Specification: 25.00kg/drum
Manufacturer: Sinopharm Group Weqida Pharmaceutical Co., Ltd.
Company Address: High-Tech Industrial Park, Economic and Technological Development Zone, Datong City, Shanxi Province
Application Item: Marketing Authorization Application for Domestically Produced Chemical API
Approval Conclusion: In accordance with the Drug Administration Law of the People's Republic of China and relevant regulations, after review, this product meets the relevant requirements for drug registration and is approved for registration.
II. Drug R&D and Market Status
Ampicillin is a broad-spectrum semi-synthetic penicillin β-lactam antibiotic. Clinically, it is mainly used for the treatment of infectious diseases caused by susceptible pathogenic bacteria, including respiratory tract infections, urinary tract infections, gastrointestinal tract infections, otolaryngological infections, as well as meningitis, endocarditis, etc.
According to the website of the Center for Drug Evaluation (CDE), other major domestic enterprises with Ampicillin API in "Class A" registration status include NCPC Xianfeng Pharmaceutical Co., Ltd., United Pharmaceutical (Inner Mongolia) Co., Ltd., and Inner Mongolia Changsheng Pharmaceutical Co., Ltd. Data from the Pharmaceutical Database (PDB) shows that the global consumption of Ampicillin API in 2023 was 681,916.22kg.
