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