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