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