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