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