Zydus Life gets final approval from US FDA for Bosentan tablets
This story was originally published at 18:58 IST on 18 February 2026
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--Zydus Life gets US FDA final nod for Bosentan tablets
MUMBAI – Zydus Lifesciences Ltd. Wednesday said it has received final approval from the US Food and Drug Administration for Bosentan tablets for a strength of 32 milligrams. The tablets are used to treat pulmonary arterial hypertension, the company said in an exchange filing.
The company will manufacture Bosentan tablets at its formulation manufacturing facility at the Special Economic Zone in Ahmedabad. Bosentan 32 mg tablets had annual sales of $9.3 million in the US, the company said, citing IQVIA data.
For the quarter ended December, Zydus Life reported a consolidated net profit of INR 10.42 billion on revenue of INR 68.65 billion. Wednesday, the company's shares ended at INR 910.05 on the National Stock Exchange, up 0.4% from the previous close. End
Reported by Akash Tirlotkar
Edited by Saji George Titus
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