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