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