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