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