An active pharmaceutical ingredient (API) manufacturing facility of Aurobindo Pharma subsidiary Apitoria Pharma near Hyderabad has been issued an observation by the U.S. Food and Drug Administration (U.S. FDA).

Apitoria Pharma’s Unit-II, an API manufacturing facility, in Sangareddy district, was inspected from September 7-15. “The inspection concluded with one observation, which is procedural in nature and we will respond to the U.S. FDA within the stipulated timeline,” Aurobindo Pharma said in a filing on Tuesday.

Aurobindo Pharma has received final approval from the U.S. Food and Drug Administration (U.S. FDA) to manufacture and market Beclomethasone Dipropionate HFA Inhalation Aerosol, 40 mcg and 80 mcg.

The product is a generic equivalent of QVAR Inhalation Aerosol, 40 mcg and 80 mcg, marketed by Teva Branded Pharmaceutical Products R&D LLC. It is Aurobindo’s first metered-dose inhaler and marks the company’s expansion into complex respiratory therapies. Beclomethasone Dipropionate HFA Inhalation Aerosol is indicated in the maintenance treatment of asthma.

“Building on our leadership in generics, we are now expanding into complex inhalation therapies to create the next wave of differentiated growth in the U.S. market,” Aurobindo said on Tuesday.

The product will be manufactured at subsidiary Aurolife Pharma’s Raleigh facility in North Carolina and expected to be launched in upcoming quarters. The U.S. market for the approved product and newer versions of the reference product was estimated at $301 million for the 12 months ended July 2026, Aurobindo said citing IQVIA numbers.

Aurobindo Pharma subsidiary Lannett Company LLC has launched a generic equivalent of GSK plc’s Advair Diskus (fluticasone propionate and salmeterol inhalation powder) in 100/50 mcg and 250/50 mcg strengths in the US market.

“The launch marks the first product from our inhalation pipeline to be commercialised in the U.S. reflecting our continued focus on expanding portfolio of complex and differentiated inhalation products,” Aurobindo Pharma said.

Advair Diskus in combination therapy is indicated for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Aurobindo had in June received the U.S. Federal Trade Commission (FTC) approval for its acquisition of the Pennsylvania-based generic pharmaceutical firm Lannett.

The U.S. Food and Drug Administration (FDA) has issued four observations to Lannett Company LLC, a U.S. subsidiary of Aurobindo Pharma, following a routine inspection of its manufacturing facility in Seymour, Indiana.

The inspection was conducted from August 17 to 21 and concluded with four observations, which the company described as procedural in nature. Aurobindo Pharma said it has responded to the observations within the stipulated timeline and remains committed to maintaining robust quality and compliance standards across its manufacturing facilities.

In June, Aurobindo Pharma announced that it had received approval from the U.S. Federal Trade Commission (FTC) for its $250 million acquisition of Pennsylvania-based Lannett. The company said Lannett specialises in developing and commercialising a diversified portfolio of complex, non-opioid controlled substances.

Lannett’s Seymour manufacturing facility has the capacity to scale production to approximately 4 billion doses annually.

The U.S. Food and Drug Administration (U.S. FDA) has issued one observation to AuroPeptides, the peptide API manufacturing subsidiary of Aurobindo Pharma, following a routine inspection of its facility in Sangareddy district near Hyderabad from August 17 to 21.

The observation relates to facility and equipment maintenance and does not pertain to data integrity or related GMP compliance. Corrective action was already initiated during the course of the inspection and a formal response will be submitted within the stipulated timeline, Aurobindo Pharma said in a filing on Friday.

Aurobindo Pharma subsidiary CuraTeQ Biologics’ biosimilars manufacturing facility in Hyderabad has received Brazilian health regulator Anvisa’s approval, enabling it to tap the broader Latin American market..

The facility underwent a good manufacturing practice (GMP) inspection by Anvisa from May 11-15, 2026 and the approval was granted following successful completion of the inspection for biological active pharmaceutical Ingredient (API) and sterile products., Aurobindo Pharma said in a filing on Tuesday.

The scope of the GMP inspection covered four biosimilar products and assessed the mammalian and microbial drug substance manufacturing facility, prefillable syringe and vial filling facility, packaging and labelling facility, QC testing and release laboratories.

Aurobindo said CuraTeQ’s drug substance and drug product GMP facility is European Medicines Agency (EMA) and WHO certified and Anvisa approval reaffirms the company’s commitment to global regulatory compliance and quality standards.