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