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