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