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