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