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