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