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Lupin Receives Approval from U.S. FDA for Doxycycline for Injection USP

March 15, 2024

Mumbai, Baltimore, March 15, 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 Doxycycline for Injection USP, 100 mg/Vial (Single-Dose Vial), to market a generic equivalent of Vibramycin® for Injection, 100 mg/Vial, of Pfizer Inc. The product will be manufactured at Lupin’s Nagpur facility in India.

Doxycycline for Injection USP is indicated to reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline and other antibacterial drugs. Doxycycline for Injection USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Doxycycline for Injection USP (RLD Vibramycin®) had estimated annual sales of USD 47 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.

Follow us on:

Twitter: https://twitter.com/LupinGlobal

LinkedIn: https://www.linkedin.com/company/lupin

Facebook: https://www.facebook.com/LupinWorld/

For further information or queries please contact –

Heena Dhedhi

Deputy General Manager – Corporate Communications

heenadhedhi@lupin.com

*Safe Harbor Statement

Vibramycin® is a registered trademark of Pfizer inc.

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