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