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