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