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