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