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