Zydus Lifesciences Secures FDA Approvals for Pediatric PAH Drug and Ammonium Lactate Cream

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for its 32 mg bosentan tablets for oral suspension. This marks a significant step in the company's strategy to penetrate the US market with treatments for rare and critical pediatric conditions, specifically Pulmonary Arterial Hypertension (PAH) in children aged three and above. The approved product is the generic version of Tracleer® tablets.

The company has also received final approval from the USFDA for Ammonium Lactate Cream, 12%. Ammonium lactate cream, 12% is a topical prescription medication indicated for the treatment of dry, scaly skin (xerosis) and an inherited dry skin condition called ichthyosis vulgaris. It is used to moisturise the skin by increasing hydration and, as an alpha-hydroxy acid, helps relieve itching, soften skin, and decrease skin scaling.

Industry data indicates that bosentan 32 mg tablets recorded annual sales of approximately $9.3 million in the United States as of December 2025. Ammonium lactate cream had annual sales of $15 million in the United States (IQVIA MAT December 2025). The generic entry by Zydus, following launches by competitors like NATCO Pharma and Teva, intensifies competition in the U.S. generic drugs sector, valued at nearly $130 billion by 2034.

Concurrently, the company has launched PEPAIR™, an innovative and affordable oscillating positive expiratory pressure (OPEP) device in India. This drug-free, handheld device aims to improve respiratory health for patients suffering from chronic lung conditions such as COPD, asthma, and bronchiectasis. Over 90 lakh patients in India suffer from chronic respiratory conditions requiring airway clearance solutions. Zydus positions PEPAIR™ as India's first affordable OPEP device, priced at ₹990 per unit.

Ammonium lactate cream will be manufactured at the group's topical manufacturing site at Changodar, Ahmedabad, and distributed by Viona Pharmaceuticals Inc. The group now has 430 approvals and has so far filed 505 ANDAs since the commencement of the filing process in FY 2003-04.

The company has achieved a significant milestone by resolving a USFDA warning letter from August 2024 with a closeout letter issued in January 2026, addressing manufacturing compliance issues. The warning letter concerned significant current Good Manufacturing Practice (CGMP) violations at its Jarod facility in Gujarat, including failures in investigating contamination, inadequate procedures for aseptic processing, and equipment maintenance.

Recent financial performance indicates positive momentum, with Q3 FY26 results showing a 7.7% rise in net profit to Rs 1,102.64 crore and a 32.3% increase in revenue to Rs 6,780.40 crore year-on-year. Zydus Lifesciences holds a market capitalization of approximately ₹91,618 crore as of February 18, 2026. Its trailing twelve months' P/E ratio stands around 18.12 to 18.56, notably below the median P/E ratio of its peers at 30.82.

The company operates within India's robust pharmaceutical sector, projected to reach $120 billion to $130 billion by 2030, with exports forming a substantial component. India's role as a global supplier of generics, ranking third in production volume, further contextualizes Zydus's strategic positioning. The promoters holding in the company stood at 75.00%, while Institutions and Non-Institutions held 18.15% and 6.85% respectively.