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