In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a BF 200 Drug Master File in Korea (BF 200 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of BF 200. The MFDS reviews the BF 200 KDMF as part of the drug registration process and uses the information provided in the BF 200 KDMF to evaluate the safety and efficacy of the drug.
After submitting a BF 200 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 BF 200 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of BF 200 suppliers with KDMF on PharmaCompass.