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