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