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