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