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