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