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