Share price of Aurobindo Pharma fell 2% in intra-day trade. The company announced that it has received approval from the US Food & Drug Administration (USFDA) to manufacture its first metered-dose inhaler in the United States. The product will be launched in the upcoming quarters by the pharma company’s subsidiary at its North Carolina facility. 

Aurobindo Pharma receives approval for HFA inhalation aerosol 

According to Aurobindo Pharma’s regulatory filing, it will manufacture and market Beclomethasone Dipropionate HFA Inhalation Aerosol in doses of 40 micrograms and 80 mcg. The inhalation product is a generic equivalent of  QVAR Inhalation Aerosol, which is marketed by Teva Branded Pharmaceutical Products R&D LLC. 

This inhaler is used as a daily maintenance and preventative measure for asthma patients and children aged 5 years or older. This product will be manufactured by the company’s wholly owned subsidiary, Aurolife Pharma LLC at its North Carolina facility, and is expected to be launched over the coming quarters. 

“This represents Aurobindo’s first metered-dose inhaler (MDI) product, marking a significant milestone in the Company’s expansion into complex respiratory therapies and strengthening its capabilities in the inhalation segment,” it added in its statement.

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Aurobindo expanding presence in US market

With the addition of this approval, Aurobindo Pharma’s cumulative US FDA ANDA approvals stand at 596, comprising 571 final approvals and 25 tentative approvals.  

“ Building on our leadership in Generics, we are now expanding into complex inhalation therapies to create the next wave of differentiated growth in the US market,” the company said in its exchange filing. 

US market for the approved product and the newer version of this inhalation product is pegged at $301 million for the twelve months ended July 2026, according to IQVIA. 

Aurobindo Pharma share price

The company’s stock was down 2% in Tuesday’s closing trade. Over the past one month, its share price has expanded by 1%, while over the past six months, its stock has delivered a return of more than 26%.