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