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