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