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