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