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