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