Aurobindo arm Apitoria gets USFDA observation for Telangana API unit | Hyderabad News

Hyderabad: Aurobindo Pharma on Tuesday informed the bourses that the US Food and Drug Administration has issued one observation for an active pharmaceutical ingredient (API) manufacturing unit of its wholly owned subsidiary Apitoria Pharma Pvt Ltd.The facility, called Unit II, was inspected by the US drug watchdog from Sept 7 to 15, 2026. The unit is located at Gaddapotharam in Sangareddy district of Telangana.Aurobindo Pharma said the observation is procedural in nature and that the company will respond to the US FDA within the stipulated timeline. It added that it will inform the stock exchanges of any further developments as required under applicable regulations.In a separate regulatory filing, Aurobindo Pharma said it has received final approval from the US drug regulator to manufacture and market its first metered-dose inhaler product, which is a generic version of Israeli player Teva’s Qvar inhalation aerosol in 40 mcg and 80 mcg dosages.It said the product will be manufactured at its Raleigh facility in North Carolina that is owned by its wholly owned step-down subsidiary Aurolife Pharma LLC. The inhaler is expected to be launched in the upcoming quarters in the US market, the company said.As per IQVIA data, the market for the approved product and newer versions of the reference product, QVAR RediHaler, was pegged at around $301 million for the 12 months ended July 2026.