How To Accept Imported APIs

The stable supply of APIs is also very important for pharmaceutical companies. China's environmental protection pressure and supervision are becoming increasingly severe, monopoly varieties are increasing, API prices are rising, and 4+7 self-owned raw material enterprises give priority to meeting their own preparations, so more and more domestic production and R&D enterprises tend to use imported APIs.
If imported APIs are purchased, how do I need to accept imported APIs?

In terms of customs, the Announcement of the State Medical Products Administration on Customs Clearance for the Import of Pharmaceutical Raw Materials and Excipients (No. 8 of 2018): For imported APIs, the importing unit can go to the port drug regulatory department to apply for the "Customs Clearance Form for Imported Drugs" with the API approval documents, certificate of origin, packing list, waybill, freight invoice, factory inspection report and other materials; GMP incoming material acceptance, first confirm whether the incoming supplier is in the qualified supplier directory, whether it is consistent with the purchase contract, delivery note, whether it has an inspection report, whether the appearance, quantity meets the regulations, etc., this is the preliminary inspection. Then the sampling is inspected, and the acceptance is completed if the inspection is qualified.

In addition, you can also choose to directly let the API enterprise integrated package processing, Tonghui's current key business includes API joint declaration, one-time import of reference preparations, clinical pre-BE/formal BE and consistency evaluation services, etc., which can help customers provide one-stop solutions. Make the process of R&D enterprises using imported APIs faster and more convenient.