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