Zydus Lifesciences Limited has received final approval from the United States Food and Drug Administration (USFDA) to market Bosentan tablets for oral suspension, 32 mg, a treatment for Pulmonary Arterial Hypertension (PAH) in children aged three years and above. The product is a generic version of Tracleer® tablets for oral suspension.
Bosentan is a dual endothelin receptor antagonist that helps reduce high blood pressure in the lungs. It is prescribed to improve exercise capacity and slow disease progression in patients with idiopathic or congenital PAH. The medicine is typically administered according to a patient’s body weight.
The approved product will be manufactured at Zydus Lifesciences’ formulation manufacturing facility located in the Special Economic Zone in Ahmedabad. The company said the approval adds to its growing portfolio of generic medicines in the United States market.
According to IQVIA data for the 12 months ending December 2025, Bosentan tablets for oral suspension recorded annual sales of approximately USD 9.3 million in the United States. Zydus said the approval will help expand treatment options for paediatric patients requiring specialised therapy for pulmonary arterial hypertension.
With this approval, the Zydus group now holds 432 USFDA approvals. Since beginning its abbreviated new drug application filing programme in FY 2003–04, the company has submitted 505 ANDAs, reflecting its continued focus on expanding its global generic product pipeline.
Zydus Lifesciences has been strengthening its manufacturing and research capabilities to support growth in regulated markets such as the United States and Europe. The company continues to invest in product development, quality systems and regulatory compliance to deliver affordable medicines across multiple therapeutic areas.
Pulmonary Arterial Hypertension is a rare and serious condition that affects blood vessels in the lungs, leading to increased pressure and strain on the heart. Treatment options such as Bosentan help manage symptoms and improve quality of life for patients.
Zydus Lifesciences Limited is a global pharmaceutical company headquartered in Ahmedabad, India, with operations across several markets. The company develops, manufactures and markets a wide range of formulations, biologics and specialty products, focusing on improving access to healthcare through affordable medicines and continued innovation in drug development.
