Tag: Aurobindo

U.S. FDA issues observation to Aurobindo Pharma arm’s API unit

September 15, 2026 admin

U.S. FDA headquarters in White Oak, Maryland | Photo Credit: Reuters 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….

Business

Aurobindo Pharma wins U.S. FDA approval for generic asthma inhaler

September 15, 2026 admin

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…

Business

Aurobindo arm Lannett launches generic of GSK’s drug in U.S.

August 31, 2026 admin

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…

Business

Aurobindo arm Lannett’s facility in U.S. gets 4 U.S. FDA observations

August 25, 2026 admin

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…

Business

U.S. FDA flags Aurobindo arm’s Hyderabad plant

August 21, 2026 admin

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…

Business

Aurobindo arm CuraTeQ Biologics’ facility secures nod from Brazil’s health regulator

July 21, 2026 admin

Aurobindo’s arm CuraTeq Biologics to make inroad into Latin American markets | Photo Credit: The Hindu 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…

Business