The product is reference listed drug of Daliresp tablets.
Roflumilast reduces inflammation in the lungs that leads to chronic obstructive pulmonary disease (COPD). It is used to prevent worsening of symptoms in people with severe COPD.
The drug will be manufactured at the group's formulation manufacturing facility in SEZ Ahmedabad, (India).
According to IQVIA MAT February 2023 data, Roflumilast tablets, 250 mcg had annual sales of $34 million in the United States.
Meanwhile, the pharma company said that it received final approval from the United States Food and Drug Administration (USFDA) for the manufacture and marketing of Estradiol Transdermal System USP, 0.014 mg/day (weekly), which is used in the prevention of postmenopausal osteoporosis. The product is bioequivalent to the Menostar Transdermal System.
The group now has 363 approvals and has so far filed over 440* ANDAs since the commencement of the filing process in FY 2003-04.
Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The company's consolidated net profit jumped 24.5% to Rs 622.90 crore on 17.9% rise in net sales to Rs 4,159.80 crore in Q3 FY23 over Q3 FY22.
Shares of Zydus Lifesciences rose 0.13% to Rs 516.40 on the BSE.
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