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