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