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