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