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