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