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