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