Indian multinational pharmaceutical manufacturing company producing generic pharmaceuticals and active pharmaceutical ingredients, marketing products in over 125 countries. Main headquarters in Hyderabad, India, with a US base in East Windsor, New Jersey.
Clinical Trials
4
0 active
Approvals
14
Total approvals
Agencies
3
Regulatory bodies
Founded
1986
Completed
2
50.0%
Withdrawn
2
50.0%
- Aurobindo Pharma received final FDA approval for Beclomethasone Dipropionate HFA Inhalation Aerosol 40 mcg and 80 mcg, its first metered-dose inhaler product. - The product is a generic equivalent of Teva's QVAR Inhalation Aerosol and is indicated for maintenance treatment of asthma as prophylactic therapy. - Manufacturing will take place at Aurolife Pharma's Raleigh, North Carolina facility, with launch expected in upcoming quarters. - Aurobindo cited IQVIA data estimating the U.S. market for the product and newer versions of the reference product at $301 million for the 12 months ended July 2026.
- Lupin has secured approval to manufacture and market its pegfilgrastim biosimilar in India, with production planned at its Nagpur facility in Maharashtra. - Pegfilgrastim is an onco-supportive therapy that helps the body produce neutrophils after chemotherapy to reduce the risk of serious infections and fever. - Lupin's Armlupeg is already approved in the US, where commercial rights are out-licensed to Valorum Biologics, while Biocon and Amneal also market US pegfilgrastim biosimilars.
- Aurobindo Pharma subsidiary Apitoria will acquire an 80% stake in A1 Biochem Group for USD 17 million, with the deal approved by Apitoria's board on July 23, 2026. - The acquisition brings front-end CRO capabilities including custom synthesis, medicinal chemistry, and analytical development, complementing Apitoria's existing large-scale API manufacturing. - A1 Biochem operates labs in Wilmington, North Carolina and Hyderabad, India, employs over 90 scientists, and has completed more than 800 projects for over 50 clients. - The transaction is expected to close within 90 to 120 days, subject to regulatory approvals, and will be funded entirely through cash consideration.
- The FTC approved Aurobindo's $250 million acquisition of Lannett on the condition that four generic drug products be divested to Quagen Pharmaceuticals LLC to preserve market competition. - The divested products include mycophenolate mofetil oral suspension, niacin ER tablets, pilocarpine tablets, and rabeprazole sodium DR tablets, which treat conditions from organ transplant rejection to dry mouth. - Without the divestitures, the FTC alleged the deal would eliminate competition between two of a limited number of competitors, potentially raising generic drug prices for millions of patients. - The transaction is expected to close before the end of June 2026 and will expand Aurobindo's U.S. manufacturing footprint with Lannett's Seymour, Indiana facility capable of producing 4 billion doses annually.
- TheraNym Biologics, Aurobindo Pharma's subsidiary, will invest $150-175 million to construct a new greenfield mammalian drug substance manufacturing facility under an expanded CMO agreement with MSD Singapore. - The new Unit 2 facility will house 60,000 liters of mammalian cell culture bioreactor capacity with downstream purification infrastructure to produce biologic drug substances for global markets. - This expansion builds upon the existing CMO relationship initiated in May 2024, significantly strengthening Aurobindo's biologics contract manufacturing capabilities and footprint. - The strategic investment reflects growing global demand for large-scale mammalian cell culture capacity and reinforces Aurobindo's long-term partnership with MSD in biologics manufacturing.
- Aurobindo Pharma plans to ramp up Penicillin-G production to over 10,000 metric tonnes annually within 12 months, with its Kakinada facility ultimately targeting 15,000 metric tonnes capacity. - The company's China manufacturing plant is expected to reach EBITDA break-even in Q4 and contribute meaningfully to bottom-line EBITDA next year. - Government relaxation on minimum import prices for Pen-G, 6 APA, and Amoxicillin is viewed as a strategic catalyst for India's antibiotic self-reliance. - The company reported Q3 revenue of ₹8,646 crore compared to ₹7,979 crore in the previous year, targeting EBITDA margins of 20-21% for FY26.
- Acrotech Biopharma, a subsidiary of Aurobindo Pharma, received FDA approval for ADQUEY (difamilast 1%) ointment, a novel non-steroidal topical PDE4 inhibitor for mild-to-moderate atopic dermatitis in patients aged 2 and older. - Pivotal Phase III trials demonstrated significantly greater IGA success rates compared to placebo after four weeks of treatment, with nasopharyngitis being the most common adverse reaction at 6%. - The approval addresses an unmet medical need for effective, long-term non-steroidal treatments that manage both inflammation and pruritus associated with eczema in millions of Americans. - ADQUEY was developed through collaboration with Otsuka Pharmaceutical, which discovered difamilast and licensed it to Acrotech in the United States since 2021.
- Aurobindo Pharma's formulation manufacturing facility in Telangana received 11 procedural observations following a US FDA inspection conducted from January 27 to February 6, 2026. - The company confirmed that all observations were procedural in nature and stated there has been no financial or operational impact from the inspection. - Aurobindo Pharma committed to submitting responses within the FDA's stipulated timeline while maintaining its focus on compliance and quality standards across all global facilities.
- The fourth quarter of 2025 witnessed an unprecedented surge in ANDA patent litigation cases, with over 80 new lawsuits filed as generic manufacturers challenged patents protecting major pharmaceutical products. - High-value drug patents faced multiple challenges, including Bayer's Kerendia (finerenone) targeted by at least 10 generic companies and AbbVie's Qulipta (atogepant) facing litigation from multiple manufacturers. - Settlement activity remained robust with over 50 cases resolved, often resulting in injunctions preventing generic entry until patent expiration while allowing FDA approval processes to continue.
- CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, has received Notice of Compliance from Health Canada for Dyrupeg, a pegylated filgrastim biosimilar indicated for cancer patients with low neutrophil counts. - Health Canada's approval confirms Dyrupeg demonstrates high similarity to an approved reference biologic drug with no clinically meaningful differences in safety or quality attributes. - The Canadian approval follows Dyrupeg's marketing authorization in the European Union and UK in 2025, expanding the biosimilar's global regulatory footprint. - The Notice of Compliance from the Biologics and Radiopharmaceutical Drugs Directorate certifies that Dyrupeg meets regulatory standards for safety, efficacy, and quality under food and drug regulations.
