In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Na2SO4 Drug Master File in Korea (Na2SO4 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Na2SO4. The MFDS reviews the Na2SO4 KDMF as part of the drug registration process and uses the information provided in the Na2SO4 KDMF to evaluate the safety and efficacy of the drug.
After submitting a Na2SO4 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 Na2SO4 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Na2SO4 suppliers with KDMF on PharmaCompass.