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