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