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