Recently, Sinopharm Group Industry Co., Ltd. (hereinafter referred to as Sinopharm Industry), the wholly-owned subsidiary of Shanghai Shyndec Pharmaceutical Co., Ltd. (hereinafter referred to as the Company), has received the Approval Notice for the Marketing Application of Chemical Active Pharmaceutical Ingredient officially verified and issued by the National Medical Products Administration (NMPA), which approves the marketing application for Codeine Phosphate. The relevant information is hereby announced as follows:
I. Basic Information of the Chemical Active Pharmaceutical Ingredient
Name of the chemical active pharmaceutical ingredient: Codeine Phosphate
Registration number: Y20180000868
Registration standard number of the chemical active pharmaceutical ingredient: YBY70682024
Packaging specification: 9kg/drum
Manufacturer: Langfang Branch of Sinopharm Group Industry Co., Ltd.
Enterprise address: Chuangye Road, Langfang Economic and Technological Development Zone
Application item: Marketing application for domestically-produced chemical active pharmaceutical ingredient
Approval conclusion: In accordance with the Drug Administration Law of the People's Republic of China and relevant regulations, upon review, this product meets the relevant requirements for drug registration and is approved for registration.
II. R&D and Market Status of the Drug
Codeine Phosphate can be used for the treatment of severe and frequent dry coughs. It also has certain analgesic and sedative effects, and is usually indicated for moderate to severe pain, as well as during local or general anesthesia.
