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