Lupin wins USFDA nod for Tiotropium Dry Powder Inhaler

Mumbai: Global pharma major Lupin Limited has announced that the company has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application for Tiotropium Bromide Inhalation Powder, 18 mcg/capsule.

The product is a generic equivalent of Spiriva HandiHaler (Tiotropium Bromide Inhalation Powder), 18 mcg/capsule of Boehringer Ingelheim Pharmaceuticals, Inc.

This product will be manufactured at Lupin’s Pithampur facility in India.

“We are delighted to receive the final approval for generic Spiriva HandiHaler from the U.S. FDA. This builds on our commitment to serving unmet needs for our patients across the world. This is the first generic approval for Spiriva HandiHaler in the U.S., and is also the first DPI approval from India for the U.S. This is an important milestone in our journey of building our respiratory franchise globally,” said Vinita Gupta, CEO, Lupin.

Tiotropium Bromide Inhalation Powder (Spiriva HandiHaler) had estimated annual sales of USD 1,264 million in the U.S. (IQVIA MAT Mar 2023).

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 specializes 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 7.9% of its revenue in research and development in FY23. 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.

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