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