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