Justoza, a Dapagliflozin brand promoted by Mankind Pharma for the treatment of Diabetes, Heart Failure, and Chronic Kidney Disease. The Active Pharmaceutical Ingredient is obtained from a DMF facility that has been licensed by the USFDA, EU GMP, and WHO GMP, confirming the highest levels of efficiency and safety around the world. The DMF grade facility product is the trusted highest quality in terms of safety and potency.
A company that intends to export pharmaceutical medications and their ingredients to the US market must submit a DMF – Drug Master File, which is a confidential report about the drug, to the USFDA – United States Food and Drug Administration in order to obtain approval for exporting. The Drug Master File supplies regulatory agencies with the essential documents to demonstrate that the manufacturing facility meets the quality and safety standards of the USFDA and other regulatory organizations throughout the world. The FDA confirms that the drug material under the DMF is of the highest quality possible.
During the launch of the drug, Atish Majumdar, President of Mankind Pharma, spoke about the company’s mission, future plans and the newly introduced drug. He 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.”
