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