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