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