News

Aurobindo Pharma will hold a meeting of the Board of Directors of the Company on 21 May 2026.

Aurobindo Pharma announced that the United States Food and Drug Administration (US FDA) inspected Aurobindo Pharma`s Unit-VII, an oral solid dosage manufacturing unit, situated at Special Economic Zone (Pharma), TSIIC, Green Industrial Park, Polepally Village, Jedcherla Mandal, Mahaboobnagar District, 509302, Telangana from 28 January to 10 February 2026. At the end of the inspection, a `Form 483` was issued with a total of 9 observations. The Unit has now received Establishment Inspection Report (EIR) classifying the facility as Voluntary Action Indicated (VAI). FDA has concluded that this inspection is now closed.

Aurobindo Pharma announced the receipt of the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Glycerol Phenylbutyrate Oral Liquid, 1.1 grams per mL, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Ravicti Oral Liquid 1.1 grams per mL, of Horizon Therapeutics U.S. Holding LLC. The product will be manufactured by Unit-III of the Company and will be launched immediately. The approved product has an estimated market size of US$ 50.2 million for the twelve months ending February 2026, according to IQVIA MAT. Aurobindo Pharma now has a total of 579 ANDA approvals (556 final approvals and 23 tentative approvals) from USFDA. Glycerol Phenylbutyrate Oral Liquid is indicated for use as a nitrogen-binding agent for chronic management of patients with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.

The board of Aurobindo Pharma at its meeting held on 06 April 2026 has approved the transfer of the Company`s domestic branded generic pharmaceutical formulations products business on a going concern basis through a Business Transfer Agreement (BTA) to Auropharm (previously known as Auro Pharma), a wholly owned subsidiary of the Company. It is in line with the Company`s strategy in further streamlining and accelerating Company`s domestic business for faster growth.

The board of Aurobindo Pharma at its meeting held on 06 April 2026 has approved buyback of up to 54,23,728 fully paid up equity shares of face value of Re 1 each (0.93% of paid up equity share capital) at a price of Rs 1,475 per equity share payable in cash for an aggregate amount of Rs 800 crore.