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