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