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