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