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