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Zydus Lifesciences gets nod for Bosentan tablets

19 Feb 2026 Evaluate

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Bosentan tablets, oral suspension, 32 mg (USRLD: Tracleer Tablets for Oral Suspension, 32 mg).

Bosentan 32 mg tablets for oral suspension are indicated for the treatment of Pulmonary Arterial Hypertension (PAH), specifically to improve exercise ability and reduce clinical worsening in children (aged 3 years and older) with idiopathic or congenital PAH. It is a dual endothelin receptor antagonist that lowers high blood pressure in the lungs, typically administered based on body weight.

Bosentan 32 mg tablets will be manufactured at the group’s formulation manufacturing facility at SEZ, Ahmedabad. Bosentan 32 mg tablets had annual sales of $9.3 million in the United States (IQVIA MAT December 2025). The group now has 432 approvals and has so far filed 505 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences (formerly known as Cadila Healthcare), a company limited by shares, incorporated and domiciled in India, operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.

Zydus Lifesciences Share Price

942.55 3.35 (0.36%)
17-Apr-2026 16:01 View Price Chart
Peers
Company Name CMP
Sun Pharma Inds. 1675.20
Dr. Reddys Lab 1239.00
Cipla 1238.30
Zydus Lifesciences 942.55
Lupin 2321.40
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