In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a BZF-60 Drug Master File in Korea (BZF-60 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of BZF-60. The MFDS reviews the BZF-60 KDMF as part of the drug registration process and uses the information provided in the BZF-60 KDMF to evaluate the safety and efficacy of the drug.
After submitting a BZF-60 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 BZF-60 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of BZF-60 suppliers with KDMF on PharmaCompass.