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