Zydus Lifesciences Limited has announced the launch of PEPAIR™, marking a significant milestone as India's first affordable Oscillating Positive Expiratory Pressure (OPEP) device. The innovative, drug-free handheld device is designed to support better respiratory health for patients suffering from chronic respiratory conditions, addressing a critical healthcare gap in the Indian market.

Product Features and Pricing

PEPAIR™ incorporates a patented design with a 3-resistance system specifically engineered to help clear congestion and support effective mucous clearance. The device aims to improve breathing in patients diagnosed with COPD, asthma, and bronchiectasis. In a patient-centric approach, the company has positioned the device at an affordable price point to ensure broader accessibility.

Market Need and Patient Impact

The launch addresses a substantial healthcare challenge, with more than 90 lakh patients suffering from chronic respiratory conditions in India. Chronic mucous hypersecretion represents a common problem among these patients, requiring effective airway clearance solutions for everyday care. OPEP-based airway clearance is recommended in established clinical guidance, but limited affordability has historically restricted access for a large proportion of patients.

Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Limited, emphasized the company's commitment to patient-centric innovation: "At Zydus, patient-centric innovation is about advancing healthcare in ways that make everyday care more accessible for patients. With PEPAIR™, India's first affordable OPEP device, we are introducing a drug-free, handheld solution designed to support better breathing for patients with COPD, asthma and bronchiectasis."

Technology and Therapeutic Benefits

OPEP therapy utilizes a handheld, translucent device that creates pressure and vibrations during exhalation to loosen mucous, open airways, and promote clearance. PEPAIR™ contributes to clearing impaired mucociliary pathways, removing airway obstruction, reducing cough, and delivering optimal therapeutic response. The device operates without requiring any pharmaceutical intervention, making it a valuable addition to respiratory care management.

Strategic Partnership

The launch represents a collaboration between Zydus Lifesciences and AeroDel Technology Innovations Pvt. Ltd, an Indian medical device company focused on simplifying inhalation through drug-delivery and pulmonary rehabilitation. AeroDel serves as both the innovator and developer of the underlying OPEP device platform for PEPAIR™ and the manufacturing partner for the project.

Company's Respiratory Portfolio

Zydus maintains its position as one of India's largest respiratory players, supported by a comprehensive legacy in oral and inhalation therapies. The company leads the oral bronchodilator segment with Deriphyllin®, recognized among India's most prescribed methylxanthines. The respiratory portfolio spans multiple therapeutic categories:

• Inhaled Corticosteroid (ICS) + Long-Acting Beta2-Agonist (LABA) combinations
• LABA + Long-Acting Muscarinic Antagonist (LAMA) formulations
• Single Inhaler Triple Therapy (SITT) solutions
• Once-daily triple therapies including Odihale®G and Umiflo® Plus

The company pioneered several innovations in the respiratory space, including being first to introduce LABA+LAMA with Forglyn® and pioneering SITT with Forglyn® Plus.

Zydus Lifesciences Limited has secured final approval from the United States Food and Drug Administration (USFDA) for Ammonium Lactate Cream, 12%, marking another milestone in the company's US pharmaceutical portfolio expansion.

Product Details and Therapeutic Applications

Ammonium lactate cream, 12% is a topical prescription medication specifically indicated for treating dry, scaly skin conditions. The cream addresses two primary conditions:

• Xerosis: General dry, scaly skin condition
• Ichthyosis vulgaris: An inherited dry skin condition

As an alpha-hydroxy acid formulation, the medication works by increasing skin hydration and providing multiple therapeutic benefits including relieving itching, softening skin, and decreasing skin scaling.

Manufacturing and Distribution Strategy

The product will be manufactured at Zydus's established topical manufacturing facility in Changodar, Ahmedabad, leveraging the company's existing infrastructure and quality systems.

Market Opportunity

The approval represents entry into a significant market segment, with Ammonium lactate cream recording annual sales of USD 15 mn in the United States according to IQVIA MAT December 2025 data. This market size indicates substantial commercial potential for the newly approved generic version.

Regulatory Portfolio Expansion

*As on 31-Dec-2025

This latest approval brings Zydus Lifesciences' total USFDA approvals to 430, while the company has filed 505 Abbreviated New Drug Applications (ANDAs) since commencing its US filing process in FY 2003-04. The consistent approval rate demonstrates the company's regulatory expertise and manufacturing quality standards.

Strategic Significance

The Ammonium Lactate Cream approval strengthens Zydus Lifesciences' dermatology portfolio in the US market. The topical medication addresses common skin conditions, potentially providing steady revenue streams from both prescription and healthcare provider channels. The company's established manufacturing capabilities and distribution partnership position it well for market entry and commercialisation of this therapeutic product.