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