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