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