A stable supply of APIs is crucial for pharmaceutical companies. With the strengthening of national environmental protection supervision and increasing numbers of monopoly varieties, prices of APIs generally tend to increase. More and more domestic production and R&D companies tend to use imported API.

If the imported APIs are procured, how to acceptance of imported APIs?

In terms of customs, the Announcement of the State Drug Administration(SDA) on Customs Clearance for the Import of Pharmaceutical Raw Materials and Excipients ([2018] No. 8), For imported APIs, the importer may go through the Imported Drug Customs Clearance Form at the port drug regulatory authority with the approval documents for APIs, Certificate of Origin, packing list, bill of lading, freight invoice, and factory inspection report, etc.. for the preliminary examination for the GMP incoming material, generally, confirm whether the incoming material supplier is in the qualified supplier list, whether it is in accordance with the procurement contract, whether the delivery note is consistent, whether it has an inspection report, whether the appearance and quantity meet the regulations, etc... Then take samples for inspection, and finally complete the acceptance inspection after passing the inspection.

In addition, you can also choose to have API pharmaceutical handle it in bulk. Guangzhou TOSUN Pharmaceutical Co., Ltd. currently focuses on businesses that include the joint declaration of APIs, one-time import of reference preparations, clinical pre-BE / formal BE and consistency evaluation services, etc. We can help our customers provide one-stop solutions and make it more convenient and efficient for R&D enterprises to use imported APIs. Please feel free to contact us via tonghuiyy218@upharm.cn.