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