In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a ZnSO4.7H2O Drug Master File in Korea (ZnSO4.7H2O KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ZnSO4.7H2O. The MFDS reviews the ZnSO4.7H2O KDMF as part of the drug registration process and uses the information provided in the ZnSO4.7H2O KDMF to evaluate the safety and efficacy of the drug.
After submitting a ZnSO4.7H2O 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 ZnSO4.7H2O API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ZnSO4.7H2O suppliers with KDMF on PharmaCompass.