Aurobindo Pharma Ltd

Aurobindo Pharma will hold a meeting of the Board of Directors of the Company on 26 May 2025.Powered by Capital Market - Live

Aurobindo Pharma Ltd fell 3.92% today to trade at Rs 1194. The BSE Healthcare index is down 1.06% to quote at 41928.48. The index is up 3.45 % over last one month. Among the other constituents of the index, Lupin Ltd decreased 3.13% and Cipla Ltd lost 2.64% on the day. The BSE Healthcare index went up 17.28 % over last one year compared to the 9.41% surge in benchmark SENSEX. Aurobindo Pharma Ltd has added 8.07% over last one month compared to 3.45% gain in BSE Healthcare index and 7.28% rise in the SENSEX. On the BSE, 5911 shares were traded in the counter so far compared with average daily volumes of 53449 shares in the past one month. The stock hit a record high of Rs 1592.55 on 13 Sep 2024. The stock hit a 52-week low of Rs 994.35 on 07 Apr 2025.Powered by Capital Market - Live

The incident, which occurred on 27 April 2025, has prompted a temporary suspension of operations at the plant facility located in Kakinada SEZ. In a regulatory filing, Aurobindo stated that the fire broke out around 10:00 PM in the coal crusher area of its Penicillin-G production unit. Preliminary findings suggest the blaze was caused by the self-ignition of coal. While certain ancillary equipment was damaged, the core manufacturing infrastructure remained unaffected. Notably, no injuries were reported. The company noted that a detailed damage assessment is underway and assured stakeholders that the facility is fully insured. As a safety measure, operations at the unit have been paused for 20 to 25 days to facilitate equipment replacement. We remain committed to resuming full operations at the earliest while maintaining the highest safety and quality standards, the company said in a statement. Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company's consolidated net profit fell 9.7% to Rs 845.81 crore while net sales increased 8.6% to Rs 7,893.15 crore in Q3 December 2024 over Q3 December 2023. Powered by Capital Market - Live

CuraTeQ Biologics s.r.o., a wholly owned step-down subsidiary of Aurobindo Pharma, announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation of Dazublys' (150 mg powder for concentrate for solution for infusion), its trastuzumab biosimilar, for the treatment of HER2-positive metastatic and early breast cancers. Trastuzumab specifically binds and inhibits the human epidermal growth factor receptor 2 (HER2) protein, which is over-expressed on certain types of solid cancers such as breast and gastric cancer. By binding to the extracellular domain of HER2, trastuzumab disrupts its ability to signal, leading to cell cycle arrest, reduced tumor growth, and potentially immune system activation to destroy cancer cells. Aurobindo Pharma's Vice Chairman and Managing Director Mr. Nithyananda Reddy said, The CHMP's positive opinion of a third biosimilar from our portfolio in a five-month time period underscores our extensive efforts in building biosimilars as one of the core businesses at Aurobindo. By 2030, we are committed to launching at least 10 biosimilars across oncology and immunology therapy segments, furthering our mission to serve patients with high-quality, cost-effective therapies. Powered by Capital Market - Live

The drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Sprycel Tablets by Bristol-Myers Squibb Company (BMS). Dasatinib is approved for treating Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in adults and children, including newly diagnosed cases. It is also indicated for Ph+ CML with resistance or intolerance to prior therapies like imatinib and for Ph+ acute lymphoblastic leukemia (ALL) with treatment resistance or intolerance. The approved product has an estimated market size of US$ 1.8 billion for the twelve months ending February 2025, according to IQVIA MAT. This marks the 181st ANDA approval (including 9 tentative approvals) from Eugia Pharma Specialties Group (EPSG) facilities, which manufacture both oncology oral and sterile specialty products. Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals, and active pharmaceutical ingredients globally in over 150 countries. The company's consolidated net profit fell 9.7% to Rs 845.81 crore in Q3 FY25 as compared with Rs 936.26 crore in Q3 FY24. Net sales increased 8.6% YoY to Rs 7,893.15 crore during the quarter ended 31st December 2024.Powered by Capital Market - Live

The said drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), XARELTO, 2.5 mg of Janssen Pharmaceuticals Inc. Rivaroxaban Tablet USP is used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and for the reduction in the risk of recurrence of DVT and of PE, for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery. Rivaroxaban Tablets USP, 2.5mg, has an estimated US market size of $447 million for the twelve months ending February 2025, according to IQVIA. The company now has a total of 540 ANDA approvals (521 Final approvals and 19 tentative approvals) from USFDA. The company has also received tentative approval from USFDA for 10 mg, 15 mg, and 20 mg strengths of Rivaroxaban Tablets USP. The estimated market size of all the strengths of Rivaroxaban tablets USP, in the US, is $8.5 billion for the twelve months ending February 2025, according to IQVIA. Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad, India. The company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company's consolidated net profit fell 9.7% to Rs 845.81 crore in Q3 FY25 as compared with Rs 936.26 crore in Q3 FY24. Net sales increased 8.6% YoY to Rs 7,893.15 crore during the quarter ended 31st December 2024.Powered by Capital Market - Live

The said drug is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), XARELTO, 2.5 mg of Janssen Pharmaceuticals Inc. Rivaroxaban Tablet USP is used to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and for the reduction in the risk of recurrence of DVT and of PE, for the prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery. Rivaroxaban Tablets USP, 2.5mg, has an estimated US market size of $447 million for the twelve months ending February 2025, according to IQVIA. The company now has a total of 540 ANDA approvals (521 Final approvals and 19 tentative approvals) from USFDA. The company has also received tentative approval from USFDA for 10 mg, 15 mg, and 20 mg strengths of Rivaroxaban Tablets USP. The estimated market size of all the strengths of Rivaroxaban tablets USP, in the US, is $8.5 billion for the twelve months ending February 2025, according to IQVIA. Aurobindo Pharma is an integrated global pharmaceutical company headquartered in Hyderabad, India. The Company develops, manufactures, and commercializes a wide range of generic pharmaceuticals, branded specialty pharmaceuticals and active pharmaceutical ingredients globally in over 150 countries. The company's consolidated net profit fell 9.7% to Rs 845.81 crore in Q3 FY25 as compared with Rs 936.26 crore in Q3 FY24. Net sales increased 8.6% YoY to Rs 7,893.15 crore during the quarter ended 31st December 2024. The scrip added 2.47% to end at Rs 1,082.55 on Friday, 11 April 2025. The stock market will remain closed today on account of Dr. Babasaheb Ambedkar Jayanti.Powered by Capital Market - Live

Aurobindo Pharma announced that the United States Food and Drug Administration (USFDA) has conducted an inspection at Raleigh Plant, North Carolina, USA, owned by Aurolife Pharma LLC, a wholly owned step-down subsidiary of the Company, established for manufacturing Inhalers and Derma products, from 24 March 2025 to 10 April 2025. The inspection was completed on 10 April 2025 and at the conclusion, the USFDA issued a Form 483 with 11 observations. These observations are procedural in nature.Powered by Capital Market - Live

CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, announced that its denosumab biosimilar, BP16, has successfully met the primary endpoints in a comprehensive pharmacokinetic (PK) and pharmacodynamic (PD) study. This study enrolled a total of 204 healthy volunteers into three groups to compare BP16 with the reference products, Prolia', obtained from both the EU and US markets. Dr. Arpitkumar Prajapati, Head of Clinical Sciences at CuraTeQ Biologics, stated, 'The results from our study confirmed that BP16 exhibits a PK profile nearly identical to the reference products, achieving key bioequivalence parameters'maximum serum concentration and area under the curve'within the established bioequivalence range of 80 -125 percent. Additionally, BP16 demonstrated comparable pharmacodynamics, safety, and immunogenicity profiles to both EU and US versions of the reference product. The study, which included 204 subjects from Australia and New Zealand, successfully met all the predefined endpoints.' Denosumab works by specifically targeting the RANK ligand (RANKL), a critical protein in the lifecycle of osteoclasts, the cells that break down bone. Denosumab's ability to inhibit RANKL makes it highly effective in treating conditions linked to bone loss, such as osteoporosis in postmenopausal women, bone metastases from cancers, and cancer treatment-related bone health issues. 'With the positive Phase 1 study results, we are optimistic about our ongoing Phase 3 study. This study is progressing across multiple sites in the EU, focusing on women with postmenopausal osteoporosis, and we anticipate its completion by May/June 2025, said Dr. Disha Dadke, Head of R&D and Regulatory Sciences at CuraTeQ Biologics. We aim to submit a Marketing Authorization application to CHMP/EMA in the third quarter of this fiscal year.' Powered by Capital Market - Live

The committee for medicinal products (CHMP) of the European Medicines Agency had adopted a positive opinion, recommending the approval of Dyrupeg. Dyrupeg is a biosimilar medicine containing the active substance pegfilgrastim, intended to reduce the duration of neutropenia and prevent febrile neutropenia in adult cancer patients treated with cytotoxic chemotherapy. Aurobindo Pharma is principally engaged in the manufacturing and marketing of active pharmaceutical ingredients, generic pharmaceuticals, and related services. Aurobindo Pharma reported a 10.04% decline in consolidated net profit to Rs 845.57 crore in Q3 FY25, compared to Rs 939.97 crore posted in Q3 FY24. Revenue from operations increased 8.53% year on year (YoY) to Rs 7,978.52 crore in the quarter ended 31 December 2024. Shares of Aurobindo Pharma fell 1.40% to currently trade at Rs 1,089.35 on the BSE.Powered by Capital Market - Live