In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ensam Drug Master File in Korea (Ensam KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ensam. The MFDS reviews the Ensam KDMF as part of the drug registration process and uses the information provided in the Ensam KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ensam KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ensam API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ensam suppliers with KDMF on PharmaCompass.