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