In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a MVC PLUS-1 Drug Master File in Korea (MVC PLUS-1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of MVC PLUS-1. The MFDS reviews the MVC PLUS-1 KDMF as part of the drug registration process and uses the information provided in the MVC PLUS-1 KDMF to evaluate the safety and efficacy of the drug.
After submitting a MVC PLUS-1 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 MVC PLUS-1 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of MVC PLUS-1 suppliers with KDMF on PharmaCompass.