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