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