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