jigs| Puli Pharmaceuticals (300630.SZ): Gadoterate Meglumine API received FDA First Adevate Letter

Environment editor 2024-05-16 18:49 8 0

Glonghui May 16 丨 Puli Pharmaceutical (300630)(300630jigs.SZ) announcedjigsAnhui Puli Pharmaceutical Co., Ltd., a wholly-owned subsidiary of the company, recently received the First Adevate Letter(FAL) issued by the U.S. Food and Drug Administration (hereinafter referred to as "FDA") for the bulk drug Gadoterate Meglumine.

According to the FDA's review process for APIs, during the ANDA review of preparations, the FDA will conduct a full Scientific Review of the technical content of the associated APIs; only after passing the review can the FAL be issued to confirm whether the APIs are sufficient to support ANDA approval.

The company has commercial production capabilities and has passed FDA pre-approval inspection. This time, it received the FAL issued by the FDA, indicating that the API USDMF can meet the application requirements of related preparation customers.

jigs| Puli Pharmaceuticals (300630.SZ): Gadoterate Meglumine API received FDA First Adevate Letter