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