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