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