Lupin gets USFDA nod to generic version of ProAir HFA
Lupin's generic Albuterol Sulphate MDI will be manufactured at its Indore (Unit III) facility in India.
Mumbai: Pharma major Lupin Limited 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 rampup 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).
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Lupin Limited is a global pharmaceutical company based in Mumbai, Maharashtra, 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.
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