Zydus Lifesciences bags USFDA nod for Bisoprolol Fumarate, Hydrochlorothiazide Tablets
The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.
Ahmedabad: 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).
Hypertension is a condition in which the blood vessels have persistently raised pressure. Blood is carried from the heart to all parts of the body in the vessels. Each time the heart beats, it pumps blood into the vessels. Blood pressure is created by the force of blood pushing against the walls of blood vessels (arteries) as it is pumped by the heart. The higher the pressure, the harder the heart has to pump.
The drug will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, India.
Bisoprolol Fumarate and Hydrochlorothiazide tablets had annual sales of USD 27.1 mn 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.
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Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is an Indian multinational pharmaceutical company headquartered in Ahmedabad. The company is primarily engaged in the manufacture of generic drugs. Zydus group has manufacturing sites and research facilities spread across five states of Gujarat, Maharashtra, Goa, Himachal Pradesh and Sikkim in India and in the US and Brazil.
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