Aurobindo Pharma Ltd

The approved product is bioequivalent and therapeutically equivalent to the reference-listed drug, Ravicti, marketed by Horizon Therapeutics U.S. Holding LLC. The company said the product will be manufactured at its Unit-III facility and will be launched immediately. According to IQVIA MAT data, the approved drug has an estimated market size of $50.2 million for the 12 months ending February 2026. With this approval, Aurobindo Pharma's total ANDA approvals from the USFDA stand at 579, including 556 final approvals and 23 tentative approvals. Glycerol phenylbutyrate oral liquid is indicated as a nitrogen-binding agent for the chronic management of patients with urea cycle disorders (UCDs) who cannot be adequately managed through dietary protein restriction and amino acid supplementation alone. Aurobindo Pharma is engaged in the manufacturing and marketing of active pharmaceutical ingredients (APIs), generic pharmaceuticals, and related services. The company reported a 7.6% rise in consolidated net profit to Rs 910.29 crore on a 9% increase in net sales to Rs 8,604.51 crore in Q3 FY26 over Q3 FY25. The counter rose 0.09% to Rs 1,387.30 on the BSE.

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 approved product is a generic version of AstraZeneca's Xigduo XR and will be manufactured at the company's Unit-IV facility of APL Healthcare, a wholly owned subsidiary, with immediate market launch planned. The combination therapy is indicated as an adjunct to diet and exercise to improve glycaemic control in adults where treatment with both medicines is appropriate. According to IQVIA data, the product has an estimated US market size of $514 million for the twelve months ending February 2026. Aurobindo is eligible for 180 days of shared generic exclusivity as one of the first applicants. As of March 31, 2026, the company had a total of 579 ANDA approvals from the USFDA, including 554 final approvals and 25 tentative approvals. Aurobindo Pharma is principally engaged in the manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals, and related services. The company's consolidated net profit rose 7.6% to Rs 910.29 crore on a 9% increase in net sales to Rs 8,604.51 crore in Q3 FY26 over Q3 FY25. Shares of Aurobindo Pharma shed 0.76% to close at Rs 1,329.60 on the BSE.

Aurobindo Pharma announced that the final approval is received from the US Food & Drug Administration (USFDA) to manufacture and market Dapagliflozin and Metformin Hydrochloride Extended-Release Tablets, 5 mg/ 500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Xigduo XR Tablets, 5 mg/ 500 mg, 5 mg/1000 mg, 10 mg/500 mg, and 10 mg/1000 mg, of AstraZeneca AB. These products will be manufactured at Unit-IV of APL Healthcare, a wholly owned subsidiary of the Company and will be launched immediately.

Aurobindo Pharma announced that the final approval is received from the US Food & Drug Administration (USFDA) to manufacture and market Dapagliflozin Tablets, 5 mg and 10 mg, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB. These products will be manufactured at Unit-IV of APL Healthcare, a wholly owned subsidiary of the Company and will be launched immediately.

The company plans to repurchase up to 54,23,728 fully paid-up equity shares, representing about 0.93% of its total paid-up equity capital. The buyback size corresponds to 3.93% and 2.62% of the company's aggregate paid-up equity share capital and free reserves based on its standalone and consolidated financial statements as at March 2025, respectively. The buyback will be undertaken on a proportionate basis from all eligible shareholders, including promoters and members of the promoter group, in accordance with applicable regulations. As per the latest available shareholding data, promoters and promoter group entities hold a 51.82% stake in the company. The board has fixed 17 April 2026 as the record date to determine the eligibility of shareholders entitled to participate in the buyback. The company also constituted a buyback committee to oversee and execute the process. It noted that the buyback price may be increased and the number of shares reduced, subject to regulatory provisions, without altering the overall buyback size. Further details, including timelines and the offer process, will be released in due course as part of the public announcement and letter of offer. Aurobindo Pharma is principally engaged in the manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals, and related services. The company's consolidated net profit rose 7.6% to Rs 910.29 crore on a 9% increase in net sales to Rs 8,604.51 crore in Q3 FY26 over Q3 FY25. Shares of Aurobindo Pharma were currently down 0.26% to Rs 1,332.45.

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.

Aurobindo Pharma has fixed 17 April 2026 as record date for the purpose of determining the entitlement and the names of equity shareholders who would be eligible to participate in the buyback.

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.

Aurobindo Pharma will hold a meeting of the Board of Directors of the Company on 6 April 2026.