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