The drug had annual sales of approximately $211.6 million as of May.
The approval was obtained from United States Food & Drug Administration for Amlodipine and Olmesartan Medoxomil tablets in dosages ranging from 5+20 mg to 10+40 mg.
The combination of the two medications offers “a powerful new treatment option for patients with hypertension” who need to reduce their blood pressure levels or who are uncontrolled on other medications, Daiichi Sankyo had said in its introduction to Azor.
With this, Glenmark has 119 products authorized for distribution in the U.S. and 66 generics pending approval with the U.S. FDA.
“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,” the company said.
Glenmark Pharmaceuticals, headquartered at Mumbai, India, is ranked among the top 75 Pharma & Biotech companies of the world in terms of revenue.