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