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