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