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