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