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