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