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