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