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