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