Mumbai, Baltimore, November 02, 2023: Global pharma major Lupin Limited (Lupin) today announced the launch of Diazepam Rectal Gel, 10 mg and 20 mg, Rectal Delivery System, after its wholly owned subsidiary, Novel Laboratories Inc., based in Somerset, New Jersey received an approval for its ANDA from the United States Food and Drug Administration (U.S. FDA).

Diazepam Rectal Gel, 10 mg and 20 mg, Rectal Delivery System is the generic version of Diastat^® AcuDialTM Rectal Delivery System, 10 mg and 20 mg, of Bausch Health US, LLC.

Diazepam Rectal Gel (RLD Diastat^® AcuDialTM) had estimated annual sales of USD 37 million in the U.S. (IQVIA MAT September 2023).

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 –

Shweta Munjal
Vice President & Global Head – Corporate Communications & Sustainability
Email: shwetamunjal@lupin.com

*Safe Harbor Statement
Diastat^® AcuDialTM are registered trademarks of Bausch Health Companies Inc. or its affiliates.