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