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