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