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