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