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