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