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