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