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