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