ZYDUSLIFE

Zydus Lifesciences ; Co Gets USFDA Final Approval for Bosentan Oral Suspension Tablets • 🇺🇸 USFDA Approval Received: Zydus gets final approval for Bosentan tablets for oral suspension (32 mg) in the US market. • 💊 Therapy Segment: Drug used for treatment of Pulmonary Arterial Hypertension (PAH), including pediatric patients. • 🏭 Manufacturing Ready: Product will be manufactured at Zydus’ SEZ facility in Ahmedabad, supporting export pipeline. • 📊 Market Opportunity: Reference product had ~USD 9.3 million annual sales in the US (IQVIA MAT Dec 2025). • 📈 Pipeline Strength: Total approvals rise further, reinforcing US generics portfolio expansion. 🟢 Impact: Positive USFDA approval supports revenue visibility in the US generics business and strengthens regulatory track record, though financial impact may be moderate due to limited market size.