Zydus receives final approval from USFDA for Bosentan tablets for oral suspension, 32 mg

Zydus Lifesciences Limited (including its subsidiaries / affiliates, hereafter referred to as "Zydus") 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 USD 9.3 mn 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.

Shares of Zydus Lifesciences Limited was last trading in BSE at Rs. 910.05 as compared to the previous close of Rs. 906.75. The total number of shares traded during the day was 19126 in over 1932 trades.

The stock hit an intraday high of Rs. 917.95 and intraday low of 900.50. The net turnover during the day was Rs. 17331233.00.

Source : Equity Bulls

Keywords

ZydusLifesciences INE010B01027 Pharmaceuticals FinalApproval USFDA BosentanTablets