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