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