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