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Highlights

• Zydus received USFDA approval for Bosentan tablets for oral suspension, 32 mg.
• The company launched PEPAIR™, an affordable drug-free OPEP device in India.
• Q3 FY26 revenue rose 30% YoY to ₹68,645 mn.

Shares of Zydus Lifesciences Ltd (NSE:ZYDUSLIFE) closed at ₹919.75 on February 19, 2026 the time of writing, up 1.07% from the previous session. The stock traded between ₹900.20 and ₹912.90 during the day, with a market capitalization of ₹91.82K Cr.

The counter has a 52-week high of ₹1,059.05 and a 52-week low of ₹795.00. The P/E ratio stands at 18.59, and the quarterly dividend amount is ₹2.76, translating into a dividend yield of 1.21%.

USFDA Nod for Bosentan Oral Suspension
On February 18, 2026, Zydus Lifesciences Limited announced final approval from the United States Food and Drug Administration (USFDA) for Bosentan tablets for oral suspension, 32 mg (USRLD: Tracleer® Tablets for Oral Suspension, 32 mg). The drug is indicated for treating Pulmonary Arterial Hypertension (PAH) in children aged three years and above to improve exercise ability and reduce clinical worsening.

The product will be manufactured at the group’s formulation facility in SEZ, Ahmedabad. According to IQVIA MAT December 2025 data, Bosentan 32 mg tablets recorded annual sales of USD 9.3 mn in the United States. Following this approval, the group now holds 432 approvals and has filed 505 ANDAs since FY 2003-04.

Affordable Respiratory Device Launched in India
On February 17, 2026, the company introduced PEPAIR™, described as India’s first affordable Oscillating Positive Expiratory Pressure (OPEP) device featuring a three-resistance system. The handheld, drug-free device is designed to support mucus clearance in patients with COPD, asthma, and bronchiectasis.

PEPAIR™ is being launched under an agreement with AeroDel Technology Innovations Pvt. Ltd and is priced at ₹990 per unit. The device aims to address access limitations in airway clearance therapy, particularly among patients with chronic respiratory conditions.

Ammonium Lactate Cream Approval
Earlier, on February 14, 2026, Zydus received USFDA approval for Ammonium Lactate Cream, 12% (USRLD: Lac-Hydrin Cream®, 12%). The topical medication is indicated for xerosis and ichthyosis vulgaris.

The cream will be produced at the Changodar, Ahmedabad facility and distributed by Viona Pharmaceuticals Inc. The product had annual sales of USD 15 mn in the US, according to IQVIA MAT December 2025 data. With this, total approvals stood at 430 at the time of announcement.

Q3 and 9M FY26 Financial Snapshot
On February 9, 2026, Zydus Lifesciences Ltd reported unaudited consolidated results for Q3 and nine months ended December 31, 2025.

For Q3 FY26, revenue from operations rose 30% YoY to ₹68,645 mn, while EBITDA increased 31% to ₹18,164 mn. Adjusted net profit stood at ₹11,109 mn, up 9% YoY.

For 9M FY26, revenue grew 17% YoY to ₹1,95,614 mn, with EBITDA at ₹59,207 mn and adjusted net profit at ₹38,640 mn.

Zydus Lifesciences Ltd is reporting regulatory approvals in the US, expanding its respiratory portfolio in India, and posting double-digit revenue growth in Q3 FY26. The stock has shown moderate movement amid these developments, while investors monitor product launches, USFDA clearances, and financial performance trends.

FAQs

Q1. What recent approvals has Zydus Lifesciences received from the USFDA?
Zydus Lifesciences received final USFDA approval for Bosentan tablets for oral suspension, 32 mg, used in pediatric PAH, and Ammonium Lactate Cream, 12%, indicated for xerosis and ichthyosis vulgaris in the US market.

Q2. What were the key financial highlights of Zydus Lifesciences in Q3 FY26?
In Q3 FY26, the company reported revenue of ₹68,645 mn, EBITDA of ₹18,164 mn with a 26.5% margin, and adjusted net profit of ₹11,109 mn, reflecting YoY growth across major metrics.

Q3. What is PEPAIR™ and why is it significant for the Indian market?
PEPAIR™ is a drug-free, handheld OPEP device launched at ₹990 per unit to assist mucus clearance in COPD, asthma, and bronchiectasis patients, addressing affordability and access gaps in respiratory care in India.