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