Lupin : March 19, 2024 Lupin Receives Approval from U.S. FDA for Aripiprazole Tablets, USP

Mumbai, Baltimore, March 19, 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 Aripiprazole Tablets USP, 2 mg, 5 mg, 10 mg,15 mg, 20 mg and 30 mg, to market a generic equivalent of Abilify® Tablets, 2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg, of Otsuka Pharmaceutical Company, Ltd. The product will be manufactured at Lupin's Pithampur facility in India.

Aripiprazole Tablets USP are indicated for the treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, irritability associated with autistic disorder and treatment of tourette's disorder.

Aripiprazole Tablets USP (RLD Abilify®) had estimated annual sales of USD 107 million in the U.S. (IQVIA MAT January 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 7.9% 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.

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
Abilify® is a registered trademark of Otsuka Pharmaceutical Co., Ltd.

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