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