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