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