Mankind Pharma has launched Justoza, a Dapagliflozin brand marketed by Mankind to treat diabetes, heart failure and chronic kidney disease, the company notified in a statement.
It further said that the Active Pharmaceutical Ingredient (API) is procured from the Drug Master File (DMF) facility approved by USFDA, EU GMP and WHO GMP, which ensures the highest global efficacy and safety standards. It is believed that quality of DMF-grade facility product is of the highest standard in terms of safety and efficacy.
DMF is an important confidential document submitted to USFDA by a manufacturer in order to get approval for exporting pharmaceutical drugs and its ingredients to the US market. DMF provides necessary documentation to regulatory agencies to prove that the manufacturing facility satisfies the quality and safety requirements of USFDA and other regulatory bodies across the world. FDA ensures that the drug substance which is subject of the DMF is of the best quality, added the statement.
Speaking on the launch, Atish Majumdar, President, Mankind Pharma, said, “The core at Mankind Pharma is to make quality and affordable medicines accessible to the Indian citizens. Launching API DMF Grade Dapagliflozin is an innovative futuristic approach to provide the best-in-class quality to the patients. This is just the beginning, we are committed to add more medicines to the list. Serving life is a mission in progress for us at Mankind Pharma.”
