FDA And DMF Certificates Obtained

Warmly congratulations to our company for successfully completing FDA and DMF registration and obtaining relevant certificates！

In 2022, Zhejiang Huili capsules Co., Ltd. successfully completed the registration with FDA and DMF and obtained relevant certificates, which indicates that our products have met the requirements and standards of the American market and is a key step taken by our company to successfully explore the North American market.

DMF is translated as "drug master files", which is a complete set of documents reflecting drug production and quality management. It mainly includes the introduction of the manufacturer, specific quality specifications and inspection methods, production process and equipment escription, quality control and quality management.

In the European community, DMF is part of the marketing license. A set of materials shall be submitted to the European community or the National Drug Administration for sale, and the marketing license shall be handled. When the supplier of the active ingredient (i.e. API) used in the drug changes, the same procedure shall be applied. And DMF is an important part of the application materials. If DMF is not provided as required, the products produced can not be sold to the countries.

In the United States, although the FDA does not specify in the official documents that raw material manufacturers exporting to the United States must report DMF data, in fact, everyone is doing it, and the FDA has also issued guidelines for preparing DMF documents.