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