By: IPP Bureau
Last updated : November 09, 2022 10:50 am
The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India
Zydus Lifesciences Limited (formerly known as Cadila Healthcare Limited) has received final approval from the United States Food and Drug Administration (USFDA) to market Bisoprolol Fumarate and Hydrochlorothiazide tablets USP, 2.5 mg/6.25 mg, 5 mg/6.25 mg, 10 mg/6.25 mg (USRLD: Ziac tablets).
Bisoprolol Fumarate and hydrochlorothiazide combination is indicated to treat high blood pressure (hypertension).
Bisoprolol Fumarate and Hydrochlorothiazide tablets had annual sales of US $27.1 million in the United States according to IQVIA data (IQVIA MAT Sep 2022).
The group now has 331 approvals and has so far filed over 428 ANDAs since the commencement of the filing process in FY 2003-04.