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