Lupin : May 6, 2024 Lupin Receives Approval from U.S. FDA for Travoprost Ophthalmic Solution USP

Mumbai, Naples, May 06, 2024: Global pharma major Lupin Limited (Lupin) today announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Travoprost Ophthalmic Solution USP, 0.004%(Ionic Buffered Solution), to market a generic equivalent to the reference listed drug (RLD)Travatan Z® Ophthalmic Solution, 0.004%, of Sandoz Inc. The product will be manufactured at Lupin's Pithampur facility in India.

Travoprost Ophthalmic Solution USP, 0.004%, is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension.

Travoprost Ophthalmic Solution USP, 0.004% (RLD Travatan Z®), had estimated annual sales of USD 77 million in the U.S. (IQVIA MAT March 2024).

About Lupin
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women's health areas. Lupin is the third-largest pharmaceutical company in the U.S. by prescriptions. The company invested 7.8% of its revenue in research and development in FY24.

Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a 'Great Place to Work' in the Biotechnology & Pharmaceuticals sector.

Please visit www.lupin.com for more information.
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For further information or queries please contact -

Heena Dhedhi
Deputy General Manager - Corporate Communications
Email: [e-mail]

*Safe Harbor Statement
Travatan Z®is a registered trademark of Novartis AG.

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