Zydus Lifesciences Limited has announced receiving final approval from the United States Food and Drug Administration (USFDA) for Bosentan tablets for oral suspension, 32 mg, marking another milestone in the company's pharmaceutical portfolio expansion in the US market.

Product Specifications and Market Details

The approved product is the generic version of Tracleer® Tablets for Oral Suspension, 32 mg. Bosentan 32 mg tablets for oral suspension are specifically indicated for treating Pulmonary Arterial Hypertension (PAH) in pediatric patients.

Therapeutic Benefits and Mechanism

Bosentan functions as a dual endothelin receptor antagonist that effectively lowers high blood pressure in the lungs. The medication is specifically designed to improve exercise ability and reduce clinical worsening in children with idiopathic or congenital PAH. The dosing is typically administered based on the patient's body weight, ensuring appropriate therapeutic levels for pediatric patients.

Manufacturing and Production

The Bosentan 32 mg tablets will be manufactured at the group's formulation manufacturing facility located at SEZ, Ahmedabad. This facility represents part of Zydus's established manufacturing infrastructure that supports its pharmaceutical operations.

Regulatory Portfolio Expansion

With this latest approval, Zydus has strengthened its regulatory portfolio in the United States market. The company's filing statistics demonstrate its sustained commitment to expanding its presence in the US pharmaceutical market.

The approval adds to Zydus's growing portfolio of USFDA-approved products, reflecting the company's continued focus on addressing therapeutic needs in specialized areas such as pediatric pulmonary arterial hypertension treatment.

Zydus Lifesciences Limited has launched ANYRA™, marking a significant milestone as India's first indigenously developed biosimilar of Aflibercept 2 mg. The announcement, made on February 19, 2026, represents a major advancement in making critical ophthalmic treatments more accessible to Indian patients. The company has also entered into an agreement with Regeneron Pharmaceuticals, Inc. and Bayer to support this launch.

Product Specifications and Indications

ANYRA™ addresses multiple serious retinal conditions that can lead to vision loss if left untreated. The biosimilar is specifically indicated for several critical ophthalmic conditions:

Addressing India's Healthcare Challenge

The launch comes at a crucial time for India's healthcare landscape, where retinal diseases affect millions of patients. The country faces a substantial burden of diabetes-related eye complications and age-related vision disorders:

These conditions collectively represent a large patient pool requiring timely anti-VEGF therapy to prevent irreversible vision loss. The chronic nature of retinal diseases necessitates repeated intravitreal injections over extended periods, making affordability and treatment continuity critical concerns for patients.

Company Leadership Perspective

Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited, emphasized the company's commitment to accessible healthcare. He stated that ANYRA™ represents "a transformative step for affordable retinal care in India" and highlighted the company's focus on "enabling patient-centric outcomes by leveraging science, health and innovation."

Zydus Biologics Portfolio

Zydus Lifesciences maintains India's largest biosimilar portfolio, featuring more than 13 biosimilars and complex biologic molecules developed and manufactured entirely within the country. The company has established comprehensive end-to-end capabilities spanning the entire biologics development spectrum, from cell line research and process engineering to clinical trials, manufacturing, and regulatory approvals.

Company Profile

Zydus Lifesciences Limited operates as an innovation-led global life sciences company with leadership positions across pharmaceuticals and consumer wellness. The organization is supported by an emerging MedTech franchise and maintains a strong international presence across the United States, India, and other global markets. As of September 30, 2025, the group employed approximately 29,000 people worldwide, including 1,500 scientists engaged in research and development activities.