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