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