Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Deferasirox tablets for oral suspension, 125 mg, 250 mg and 500 mg.
Deferasirox tablets are indicated for the treatment of chronic iron overload due to blood transfusions (transfusional hemosiderosis) in patients 2 years of age and older. The drug is generic version of Exjade tablets of Novartis Pharmaceuticals Corporation.
According to IQVIA sales data for the 12‐month period ending November 2019, the Exjade tablets achieved annual sales of approximately $106.4 million.
Glenmark’s current portfolio consists of 165 products authorized for distribution in the U.S. marketplace and 43 ANDA’s pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio.
On a consolidated basis, Glenmark Pharmaceuticals’ net profit fell 17.2% to Rs 255.50 crore on 8.8% rise in net sales to Rs 2,763.73 crore in Q2 September 2019 over Q2 September 2018.
Glenmark Pharmaceuticals is a global innovative pharmaceutical company with operations in more than 50 countries primarily focused in the areas of oncology, respiratory and dermatology.