Aurobindo Pharma shares came under pressure on Tuesday even as the company received a key US regulatory approval for its first metered-dose inhaler.
The stock closed at 1.18% lower as the company announced that the US Food and Drug Administration had granted final approval to manufacture and market Beclomethasone Dipropionate HFA Inhalation Aerosol in 40 mcg and 80 mcg strengths.
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The product is a generic equivalent of QVAR Inhalation Aerosol, marketed by Teva Branded Pharmaceutical Products R&D LLC.
The inhaler will be manufactured at the company's Raleigh facility in North Carolina, owned by its wholly owned step-down subsidiary Aurolife Pharma LLC. Aurobindo expects to launch the product in the upcoming quarters.
The approval marks Aurobindo's expansion into complex respiratory therapies and strengthens its capabilities in the inhalation segment. The company said it is expanding into complex inhalation therapies to create the next wave of differentiated growth in the US market.
According to IQVIA data cited by the company, the US market for the approved product and newer versions of the reference product, QVAR RediHaler, was estimated at around $301 million for the 12 months ended July 2026.
The approval takes Aurobindo Pharma's cumulative USFDA ANDA approvals to 596, comprising 571 final approvals and 25 tentative approvals, further strengthening its portfolio of complex and differentiated products.
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The product is indicated for the maintenance treatment of asthma as prophylactic therapy in patients aged five years and older.
For investors, the latest approval marks Aurobindo's entry into the metered-dose inhaler segment. However, the commercial impact will depend on the product's launch timeline and its performance in the US market.
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