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