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