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