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