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