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