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