Mumbai, Baltimore: Pharma major Lupin Limited (Lupin) announced today that it has received approval from the United States Food and Drug Administration (U.S. FDA) for its Albuterol Sulfate Inhalation Aerosol, 90 mcg (base)/actuation, a generic version of ProAir® HFA. Lupin’s generic Albuterol Sulphate MDI will be manufactured at its Indore (Unit III) facility in India.

ProAir® HFA (Albuterol Sulfate Inhalation Aerosol) is the registered trademark of Teva Branded Pharmaceutical Products R&D, Inc. (Teva) and is indicated for the treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms.

Commenting on the development, Vinita Gupta, CEO, Lupin said, “Approval of our generic Albuterol MDI is a significant milestone in our complex generics evolution and a validation of our Inhalation team’s development capabilities, backed by our global manufacturing strength in handling multiple dosage forms. The approval is timely as Albuterol MDI is a key rescue inhalation product for asthma patients who are at an increased risk of COVID-related complications.  We look forward to launching the product this quarter and expect a steady ramp-up through the fiscal year.”

The total Albuterol Sulfate Inhalation Aerosol market had U.S. sales of approximately US$2.9 billion, of which the ProAir® HFA market accounted for US$1.3 billion (IQVIA MAT June 2020).

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 Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.

The Company enjoys leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has 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 and in India by global revenues. The Company invests 9.6 % of its revenues on research and development.

Lupin has fifteen manufacturing sites, seven 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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*Safe Harbor Statement

ProAir® HFA is a registered trademark of Teva Respiratory, LLC.