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Aurobindo Pharma's Apitoria Unit Receives VAI Classification from USFDA

Aurobindo Pharma announced that its wholly owned subsidiary Apitoria Pharma's Unit-V API manufacturing facility in Telangana received VAI classification from USFDA. The inspection conducted from December 1-12, 2025 resulted in Form 483 with three observations, and the company has now received the Establishment Inspection Report confirming the VAI status with the inspection officially closed.

18Mar 26

US FDA Issues Form 483 With 9 Observations to Aurobindo Pharma's Eugia Unit

Aurobindo Pharma received FDA Form 483 with 9 observations for its Eugia Pharma Unit-II facility in Bhiwadi, Rajasthan, following November inspection. The FDA classified the facility as 'Official Action Indicated', requiring formal corrective response, though the company anticipates no immediate business impact.

13Mar 26

Aurobindo Pharma Faces Confirmed GST Demand of Rs. 77.61 Crore from Tax Authorities

Aurobindo Pharma Limited faces a confirmed GST demand of Rs. 77.61 crore plus equal penalty from tax authorities for alleged excess IGST refunds and compliance violations during 2017-2020. The company has paid Rs. 23.71 crore under protest and reversed Rs. 8.78 crore in ITC. While maintaining no material financial impact, the pharmaceutical company plans to appeal the decision at the GST Appellate Tribunal.

12Mar 26

Aurobindo Pharma's APL Healthcare Unit-IV Receives VAI Classification Following US FDA Inspection

Aurobindo Pharma announced that its wholly owned subsidiary APL Healthcare's Unit-IV facility in Andhra Pradesh has received VAI classification from the US FDA following a 10-day inspection in December 2025. The facility received an official Establishment Inspection Report confirming the VAI status with five observations noted, and the inspection is now officially closed.

04Mar 26

Eugia Pharma Launches Generic Pomalidomide Capsules as First-to-File Applicant

Eugia Pharma Specialities Limited, Aurobindo Pharma's wholly owned subsidiary, has launched pomalidomide capsules in multiple strengths as a First-to-File ANDA applicant for the generic version of Pomalyst®. The product targets a US$ 3.3 billion market opportunity and will be manufactured at Eugia Unit-I facility.

02Mar 26

Aurobindo Pharma's P Sarath Chandra Reddy Discharged in Delhi Liquor Policy Case

Delhi court discharged Aurobindo Pharma's Non-Executive Director P Sarath Chandra Reddy and 22 others in the Delhi Liquor Policy case after finding no evidence of conspiracy or corruption. The company issued official clarification under SEBI regulations confirming complete discharge from all CBI charges.

02Mar 26

US FDA Completes Inspection of Aurobindo Pharma's Eugia Unit with Four Observations

The US FDA has completed its inspection of Aurobindo Pharma's subsidiary Eugia Pharma Specialties Unit I manufacturing facility in Telangana, resulting in four regulatory observations. The company has committed to respond within FDA timelines and confirmed no impact on operations or financials.

26Feb 26

Eugia Pharma Receives USFDA Approval for Everolimus Tablets Across Multiple Dosages

Aurobindo Pharma's wholly owned subsidiary Eugia Pharma Specialities Limited has secured USFDA approval for Everolimus Tablets across four dosage strengths, bioequivalent to Novartis' Zortress Tablets. The approval targets a US$ 78 million market opportunity with commercial launch planned for Q1 FY27, marking the 184th ANDA approval for the Eugia Pharma Specialities Group facilities.

25Feb 26

Aurobindo Pharma Sees ₹107.01 Crore Block Trade on NSE

Aurobindo Pharma Limited executed a significant block trade on NSE worth ₹107.01 crores, involving 883,262 shares at ₹1211.50 per share. The transaction represents substantial institutional activity in the pharmaceutical company's stock through the block trade mechanism.

24Feb 26

Aurobindo Pharma Incorporates New Wholly Owned Subsidiary Engenra Biologics Private Limited

Aurobindo Pharma Limited incorporated Engenra Biologics Private Limited as a wholly owned subsidiary on February 24, 2026, with an initial share capital of Rs. 10 lakhs comprising 1,00,000 equity shares of Rs. 10 each. The subsidiary, established through 100% cash subscription, aims to expand contract manufacturing and pharmaceutical manufacturing operations. No regulatory approvals were required for the incorporation, and the new entity operates as a related party within the pharmaceuticals industry.

24Feb 26

Aurobindo Pharma Issues Postal Ballot Notice for Independent Director Appointment

Aurobindo Pharma Limited has issued a postal ballot notice seeking shareholder approval for appointing Dr. Punita Kumar Sinha as Independent Director for a three-year term from February 9, 2026 to February 8, 2029. The remote e-voting period runs from February 27, 2026 to March 28, 2026, with February 20, 2026 as the cut-off date for voting eligibility. Dr. Sinha brings over three decades of capital markets experience and previously served as Senior Managing Director at Blackstone Asia Advisors.

19Feb 26

Aurobindo Pharma Faces ₹169.84 Crore GST Demand Over Alleged Erroneous Refunds

Aurobindo Pharma faces a ₹169.84 crore GST demand from the Additional Commissioner of Central Tax, Ranga Reddy GST Commissionerate, over alleged erroneous ITC refunds from its EOU Unit 3 during September-December 2022. The disputed amount includes ₹84.92 crore in GST and an equal penalty. The company maintains no material financial impact and will appeal the decision, citing pending Writ Petitions in Telangana High Court and favorable Karnataka High Court precedent in similar cases.

18Feb 26

Aurobindo Pharma Clarifies US FDA Inspection Status Following Stock Exchange Queries

Aurobindo Pharma Limited issued a clarification to NSE and BSE on February 18, 2026, regarding news reports about a US FDA inspection at Unit-VII. The company confirmed it had previously disclosed the inspection completion on February 10, 2026, and emphasized its compliance with SEBI disclosure regulations. The pharmaceutical company stated that routine regulatory inspections are part of normal operations and that all material information has been adequately disclosed to exchanges.

16Feb 26

Aurobindo Pharma Reports Strong Q3FY26 Performance with 8.4% Revenue Growth

Aurobindo Pharma reported strong Q3FY26 results with 8.4% YoY revenue growth to Rs. 8,646 crores and EBITDA of Rs. 1,773 crores at 20.5% margin. European business led growth with 27% YoY increase to Rs. 2,703 crores, while US operations remained stable with injectable sales growing 17% YoY. The company's Pen-G facility ramped up production to 10,000 MT annually, benefiting from government's MIP policy on key antibiotics. Management expressed confidence in achieving higher-end EBITDA margins of 20-21% for FY26.

13Feb 26

Aurobindo Pharma's Subsidiary Acrotech Receives FDA Approval for ADQUEY Ointment for Atopic Dermatitis Treatment

Acrotech Biopharma Inc., a wholly owned step-down subsidiary of Aurobindo Pharma Limited, received US FDA approval on February 13, 2026, for ADQUEY (difamilast 1%) ointment to treat mild-to-moderate atopic dermatitis in adults and pediatric patients aged 2 and older. The novel, non-steroidal, topical PDE4 inhibitor was developed in collaboration with Otsuka Pharmaceutical and demonstrated superior efficacy in Phase III trials. This approval provides a new treatment option for millions of Americans with atopic dermatitis, with the most common adverse reaction being nasopharyngitis at 6%.

11Feb 26

Aurobindo Pharma Publishes Q3FY26 Results in Newspaper Advertisement

Aurobindo Pharma formally published its Q3FY26 unaudited financial results in Business Standard and Nava Telangana newspapers on February 11, 2026. The results demonstrate strong consolidated performance with total income of ₹86,459.0 million (8.36% YoY growth), net profit of ₹9,098.0 million, and earnings per share of ₹15.67, reflecting the company's robust operational performance.

02Feb 26

Aurobindo Pharma Schedules Q3FY26 Earnings Call for February 10, 2026

Aurobindo Pharma Limited has scheduled an earnings call for February 10, 2026 at 8:30 AM IST to discuss Q3FY26 unaudited financial results for the quarter and nine months ended December 31, 2025. The announcement was made under SEBI Regulation 30(2) requirements, with notifications sent to NSE and BSE. The call will be conducted via Zoom with mandatory pre-registration, and earnings presentation will be available on the company website post-announcement.

02Feb 26

Aurobindo Pharma Issues Fresh Clarification on Share Volume Movement Post-MIP Policy

Aurobindo Pharma provided updated clarification to stock exchanges on February 2, 2026, maintaining that significant trading volume movement continues to be market-driven following the government's January 29, 2026 MIP notification on Penicillin-G and related compounds. The company emphasized that information was already in public domain through DGFT website and reaffirmed regulatory compliance with no pending announcements.

23Jan 26

Aurobindo Pharma Establishes Wholly Owned Subsidiary in Philippines for Business Expansion

Aurobindo Pharma Limited has incorporated Aurobindo Pharma Philippines Inc. as a wholly owned subsidiary through Helix Healthcare B.V. on January 23, 2026. The new entity was established with an initial share capital of PESO 120,000,000 (approximately ₹17.00 crores) to expand pharmaceutical business operations in the Philippines market. The incorporation required no regulatory approvals and represents a strategic expansion move in the Southeast Asian pharmaceutical sector.

23Jan 26

Aurobindo Pharma shares fall 2.02% as stock trades among top losers on Nifty Midcap 150

Aurobindo Pharma shares fell 2.02% to ₹1,122.20, ranking among top losers on Nifty Midcap 150. The pharmaceutical company reported revenue growth of 9.38% to ₹31,723 crores in March 2025, with quarterly performance showing positive momentum in sales and net profit. Despite revenue growth, the company's net profit of ₹3,515 crores remained below historical peaks, while cash flow from operations improved significantly to ₹3,924 crores.

13Jan 26

USFDA Approval for Advair Generic Creates Mixed Impact for Aurobindo Pharma and Cipla

Respirent Pharmaceuticals and Lannett received USFDA approval for generic Advair Diskus, creating mixed implications for Indian pharma companies. Aurobindo Pharma benefits through its pending $250 million Lannett acquisition announced in July 2025, expected to close within two months. The approval strengthens Aurobindo's respiratory portfolio if the acquisition includes this newly approved product. However, increased competition poses challenges for Cipla, which filed its Advair generic application in 2020 and awaits approval, with estimated peak sales of $100 million and potential launch in second half of FY27.

13Jan 26

Respirent and Lannett Secure Final FDA Approval for Generic Advair Asthma Treatment

Respirent and Lannett have received final FDA approval for their generic Advair medication, used to treat asthma in patients aged four and older. This regulatory milestone enables commercial launch of the generic alternative and introduces additional competition in the respiratory medication market. The development has implications for pharmaceutical companies including Aurobindo Pharma and Cipla, potentially affecting market dynamics in the asthma treatment segment.

13Jan 26

Respirent and Lannett Secure FDA Approval for Generic Advair Asthma Treatment

Respirent and Lannett have received final approval for their generic Advair formulation, used for treating asthma in patients aged four and older. This regulatory milestone benefits associated pharmaceutical companies Aurobindo Pharma and Cipla, creating opportunities in the respiratory therapeutics market. The approval enhances treatment accessibility by providing a cost-effective alternative to branded asthma medications for pediatric and adult patients.

09Jan 26

Aurobindo Pharma's CuraTeQ Biologics Receives Health Canada Approval for Cancer Drug Biosimilar Dyrupeg

Aurobindo Pharma's subsidiary CuraTeQ Biologics has received Notice of Compliance from Health Canada's Biologics and Radiopharmaceutical Drugs Directorate for Dyrupeg, a pegylated filgrastim biosimilar. The drug is indicated for cancer patients with neutropenia, a condition involving low levels of neutrophils, which are essential white blood cells for immune function. This regulatory approval allows CuraTeQ Biologics to market the biosimilar treatment in Canada, strengthening Aurobindo Pharma's oncology portfolio in international markets.

09Jan 26

Aurobindo Pharma's CuraTeQ Biologics Receives Health Canada Approval for Dyrupeg Biosimilar

Aurobindo Pharma's biologics subsidiary CuraTeQ Biologics received Health Canada's Notice of Compliance for biosimilar product Dyrupeg on January 9, marking a key regulatory milestone. The approval confirms the product meets safety, efficacy and quality standards. The company recently acquired Khandelwal Laboratories' business for ₹325 crores and terminated a biosimilar partnership with BioFactura as part of portfolio prioritisation.

09Jan 26

Aurobindo Pharma's CuraTeQ Biologics Receives Health Canada Approval for Biosimilar Dyruppeg

CuraTeQ Biologics, Aurobindo Pharma's wholly owned subsidiary, has received Notice of Compliance from Health Canada for Dyruppeg, its pegylated filgrastim biosimilar. The approval confirms the product meets regulatory standards for safety, efficacy, and quality, with Health Canada verifying high similarity to reference biologic drugs. This follows 2025 marketing authorizations from the European Commission and MHRA UK, while three additional biosimilar applications remain under Health Canada review.

09Jan 26

Aurobindo Pharma's Curateq Biologics Receives Health Canada Approval for Dyrupeg Biosimilar

Curateq Biologics, subsidiary of Aurobindo Pharma Limited, has received Health Canada approval for its Dyrupeg biosimilar product. The approval confirms the product meets required safety, efficacy, and quality standards set by Canadian regulatory authorities. This regulatory milestone strengthens Aurobindo Pharma's biologics portfolio and establishes presence in the Canadian pharmaceutical market.

08Jan 26

Aurobindo Pharma schedules investor group plant visit for January 13, 2026

Aurobindo Pharma Limited has scheduled an investor group plant visit arranged by Investec for January 13, 2026, at its Vizag and Kakinada facilities from 09:00 AM to 05:00 PM IST. The company has informed stock exchanges that no unpublished price sensitive information will be discussed during the in-person interactions, and the schedule remains subject to potential changes due to exigencies from either party.

02Jan 26

Aurobindo Pharma Subsidiary Acquires Khandelwal's Non-Oncology Business for ₹3,250 Cr

Aurobindo Pharma's wholly-owned subsidiary Auro Pharma Limited successfully acquired Khandelwal Laboratories' branded non-oncology prescription formulations business for ₹3,250 crores through a Business Transfer Agreement effective January 1. The acquisition includes 23 brands across 67 SKUs, 9 pipeline products, and a distribution network of over 1,600 stockists, strengthening the company's domestic pharmaceutical presence in anti-infective and pain management segments.

30Dec 25

Aurobindo Pharma Plans to Acquire 26% Stake in Solar Power Company

Aurobindo Pharma Ltd has announced plans to acquire up to 26% stake in Swarnaakshu Solar Power Private Limited, subject to state government approval by March 31, 2026. This strategic investment marks the pharmaceutical company's diversification into the renewable energy sector.

30Dec 25

Government to Set Minimum Import Price for Penicillin to Boost Local API Manufacturing Under PLI Scheme

The Indian government plans to establish a minimum import price for penicillin API to support domestic manufacturing under the Production Linked Incentive (PLI) scheme. This move aims to reduce dependence on imported APIs and strengthen India's pharmaceutical manufacturing ecosystem. The policy is expected to level the playing field between local producers and international suppliers, potentially benefiting companies like Aurobindo Pharma. The initiative aligns with the government's goal of achieving self-reliance in pharmaceutical manufacturing, particularly for critical antibiotics.

29Dec 25

Aurobindo Pharma Shares in Focus After Strategic Portfolio Moves

Aurobindo Pharma is making strategic portfolio moves with subsidiary CuraTeQ terminating its BioFactura licence agreement for ustekinumab biosimilar BFI-751 by mutual consent, while Helix Healthcare expands its Chinese presence by acquiring additional 20% stake in Luoxin Aurovitas for $5.13 million, increasing ownership to 50%.

27Dec 25

Aurobindo Pharma Subsidiary Terminates Biosimilar Licensing Agreement with BioFactura Inc

CuraTeQ Biologics, a wholly owned subsidiary of Aurobindo Pharma, has mutually terminated a licensing agreement with BioFactura Inc, USA. The agreement, signed on July 7, 2023, was for the development and commercialization of BFI-751, a proposed ustekinumab biosimilar to Stelara. The termination, effective December 27, 2025, is attributed to strategic portfolio prioritization and is not expected to materially impact the company's overall biosimilars strategy. The original agreement included profit-sharing and global manufacturing rights for CuraTeQ, with milestone-based license fees for BioFactura.

23Dec 25

Aurobindo Pharma to Acquire Additional 20% Stake in Chinese Joint Venture for USD 5.125 Million

Aurobindo Pharma plans to purchase an additional 20% stake in its Chinese joint venture, Luoxin Aurovitas Pharma, for USD 5.125 million. The acquisition aims to strengthen the company's presence in the Chinese market and expand its manufacturing capabilities. The deal, expected to close within 3 months, involves Shandong Luoxin as the joint venture partner. This strategic move aligns with Aurobindo Pharma's goal to enhance its international operations and production capacity in key Asian markets.

18Dec 25

Aurobindo Pharma: US FDA Completes Inspection at APL Healthcare Unit-IV

Aurobindo Pharma announced completion of US FDA inspection at its APL Healthcare Unit-IV facility in Andhra Pradesh from December 08-17, 2025. The inspection resulted in a Form 483 with five procedural observations that the company will address within regulatory timelines, with no impact on financial operations.

15Dec 25

Aurobindo Pharma Unit Receives FDA Form 483 with Three Observations Following US Inspection

Aurobindo Pharma announced that the US FDA has completed an inspection of Unit-V at Apitoria Pharma Private Ltd, a subsidiary. The regulatory authority issued a Form 483 with three observations. This routine inspection is part of the FDA's oversight to ensure compliance with Good Manufacturing Practices in pharmaceutical facilities.

12Dec 25

Aurobindo Pharma Gets FDA Form 483 with 3 Observations

The US FDA completed an inspection at Apitoria Pharma's Unit-V API manufacturing facility, a subsidiary of Aurobindo Pharma, and issued Form 483 with three observations. The company states this does not impact facility operations and will respond within the stipulated timeline. Aurobindo Pharma emphasizes its commitment to maintaining high-quality manufacturing standards globally.

26Nov 25

Aurobindo Pharma Faces Pressure from Chinese Competition in Pen-G Market

Aurobindo Pharma is experiencing difficulties in its Penicillin G (Pen-G) segment due to declining prices caused by increased Chinese imports. The company is also struggling to boost its Pen-G production capacity. Despite these challenges, Aurobindo's overall financial position remains strong, with total assets increasing by 10.46% to ₹49,785.00 crore and total equity growing by 9.37% to ₹32,646.90 crore compared to the previous year. Macquarie has maintained an Underperform rating on Aurobindo Pharma stock with a target price of ₹1,010.

14Nov 25

Aurobindo Pharma: FDA Inspections at Multiple Units Yield Mixed Results

Aurobindo Pharma's Telangana API manufacturing unit received an Establishment Inspection Report (EIR) with a 'Voluntary Action Indicated' (VAI) classification from the FDA, indicating improvement from a previous warning letter. The FDA deemed the company's corrective actions adequate. Meanwhile, Eugia Pharma Specialities, a subsidiary, completed an FDA inspection at its Bhiwadi formulation facility, resulting in 9 procedural observations.

07Nov 25

Aurobindo Pharma Sets Ambitious Targets for FY'26, Including €1 Billion Revenue from Europe

Aurobindo Pharma has announced several financial and operational targets during a recent conference call. The company aims to achieve EBITDA breakeven for its China plant by Q3 or Q4 of FY'26. For FY'26, Aurobindo projects EBITDA margins of 20-21% and over €1 billion revenue from Europe. Growth drivers include ramp-up of Pen-G facility, launch of biosimilar portfolio, progress in biologic CMO, enhancement of injectable business, supply from China plant to Europe, new product releases, and the acquisition of Lannett in the U.S.

06Nov 25

Aurobindo Pharma Expands Kakinada Plant, Expects China Facility to Break Even Soon

Aurobindo Pharma plans to increase production at its Kakinada Pen-G plant. The company projects its China plant to reach break-even in Q3 or Q4. Revlimid sales were low in Q2 with no sales expected in Q3. No major capital expenditures are planned. Q2 FY26 financial results show revenue growth of 6.30% YoY to ₹8,286.00 crore, EBITDA up 7.10% to ₹1,678.00 crore, and net profit increase of 3.80% to ₹848.00 crore.

05Nov 25

Aurobindo Pharma Reports 6.3% Revenue Growth to ₹8,286 Crores in Q2

Aurobindo Pharma announced Q2 financial results with consolidated revenue of ₹8,286.00 crores, up 6.3% year-on-year. Profit after tax increased by 3.8% to ₹848.00 crores. US Formulations contributed 43.9% of revenue, while Europe saw 17.8% growth. EBITDA grew 7.1% to ₹1,678.00 crores with a 20.3% margin. R&D spending was ₹414.00 crores. The company filed 13 ANDAs, received 7 final approvals, and launched 6 products. Aurobindo maintained a net cash position of $170.00 million and generated $57.00 million in free cash flow. Several biosimilar products received approvals in Europe and the UK.

04Nov 25

Aurobindo Pharma Announces Senior Management Changes: Two Key Executives Depart

Aurobindo Pharma Limited has disclosed significant changes in its senior management team. Dr. Mandepudi Sudhakara Reddy, Associate President of Corporate QA, has resigned effective November 4, 2025, to pursue a new career opportunity. Mr. K.P. Ravinatha Shetty, President of Operations, will retire due to superannuation on November 3, 2025. These changes were announced in compliance with SEBI regulations.

23Oct 25

Aurobindo Pharma Expands Footprint in Latin America with New Chilean Subsidiary

Aurobindo Pharma's wholly owned stepdown subsidiary, Eugia Pharma B.V, has incorporated a new subsidiary in Chile named Eugia Pharma Chile SpA. The new entity, formed on October 7, 2025, aims to expand the pharmaceutical products business in Chile. It has an initial share capital of CLP 1,000,000 (USD 1,050) with 100 shares at a nominal value of CLP 10,000 each. This strategic move strengthens Aurobindo Pharma's presence in Latin America and demonstrates its commitment to global expansion.

23Oct 25

Aurobindo Pharma Expands Global Footprint with New Subsidiary in Chile

Aurobindo Pharma has incorporated a new wholly owned subsidiary, Aurobindo Pharma Chile SpA, in Chile on October 7, 2025. The subsidiary, owned by Helix Healthcare B.V. (a wholly owned subsidiary of Aurobindo Pharma), has an initial share capital of CLP 1,000,000 (USD 1,050) with 100 shares at a nominal value of CLP 10,000 each. This strategic move aims to expand Aurobindo's pharmaceutical products business in Chile, aligning with the company's global expansion strategy. The incorporation required no governmental or regulatory approvals and complies with SEBI regulations.

14Oct 25

Aurobindo Pharma Promoters Secure Rs 2,000 Crore for Real Estate Ventures

Aurobindo Pharma's promoter group has raised Rs 2,000 crore through a structured financing deal for their real estate arm, Auro Realty. The funding, split into two tranches with different tenors and interest rates, will be used for platform acquisitions and securing assets like the Taj Banjara in Hyderabad. The deal is backed by pledged promoter entities, additional collateral worth over Rs 2,500 crore, and personal and corporate guarantees. This move represents a strategic expansion beyond pharmaceuticals, with multiple exit options for lenders including refinancing, project cash flows, and asset monetization.

07Oct 25

Aurobindo Pharma's Hyderabad Unit Under US FDA Scrutiny

Aurobindo Pharma's Hyderabad manufacturing unit is facing scrutiny from the US FDA, raising concerns among investors. The situation draws parallels with Lupin's Pithampur unit, which previously faced regulatory challenges. While specific details of FDA concerns are undisclosed, potential impacts include regulatory compliance issues, market access limitations, investor confidence fluctuations, and financial implications. This development occurs as Indian pharmaceutical companies increase focus on quality control and regulatory compliance to maintain global competitiveness.

01Oct 25

Aurobindo Pharma Completes Internal Restructuring: CuraTeQ Biologics Ownership Transferred

Aurobindo Pharma has finalized the transfer of CuraTeQ Biologics s.r.o. from Helix Healthcare B.V. to Curateq Biologics B.V. on September 30, 2025. The transaction, part of an internal restructuring process, was completed ahead of schedule and received approval from Czech authorities. Additionally, Mr. S. Venkatesh Kumar, Associate Vice President, has resigned effective the same date.

26Sept 25

Aurobindo Pharma Extends Deadline for Subsidiary Share Transfer and Establishes New Entity in Malta

Aurobindo Pharma has extended the deadline for transferring shares of CuraTeQ Biologics s.r.o. from Helix Healthcare B.V. to Curateq Biologics B.V. from August 31, 2025, to November 30, 2025. The delay is due to pending receipt of an updated business register from Dutch authorities. The company has also postponed its plans to acquire a 26% stake in Swarnaakshu Solar Power Private Limited to December 31, 2025. Additionally, Aurobindo Pharma has established a new wholly-owned subsidiary, Curateq Biologics, in Malta.

26Sept 25

Aurobindo Pharma Extends Timeline for 26% Stake Acquisition in Swarnaakshu Solar Power

Aurobindo Pharma has extended its timeline to acquire a 26% stake in Swarnaakshu Solar Power Private Limited to December 31, 2025, from the previous target of September 30, 2025. The extension is due to pending state government approval for setting up a captive solar power plant. This move is part of Aurobindo's efforts to integrate renewable energy sources into its operations, potentially reducing its carbon footprint and energy costs.

23Sept 25

Aurobindo Pharma's Denosumab Biosimilar Targets $7 Billion Global Market

Aurobindo Pharma has successfully completed Phase 3 clinical studies for its Denosumab biosimilar, targeting the $7 billion global market for osteoporosis and bone metastasis treatment. The company plans to file for regulatory approvals in the US, EU, and other key markets starting January 2026, with anticipated European approval by end-2026 and US approval in 2027. CEO Satakarni Makkapati expects biosimilars to capture 30-50% of the innovator market between 2025-2030, with initial potential sales of $1.50-1.60 billion, potentially growing to $3.00-4.00 billion by 2030. However, the company faces challenges including potential price erosion and market competition.

19Sept 25

Aurobindo Pharma: CuraTeQ Biologics Completes Successful Phase 3 Study for Denosumab Biosimilar; Minor Fire at APL Healthcare Unit

CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, has successfully completed a Phase 3 clinical study for its denosumab biosimilar, comparing it to Prolia. The study, involving 446 postmenopausal women with osteoporosis, met all clinical endpoints, showing no significant differences from the reference product. The company plans to submit regulatory filings in key markets from January 2026. Separately, a minor fire occurred at APL Healthcare Limited Unit-IV, temporarily affecting about 3% of monthly production capacity.

17Sept 25

Aurobindo Pharma Expands Footprint with New Malaysian Subsidiary

Aurobindo Pharma has incorporated a new wholly-owned subsidiary, Aurobindo Pharma (Malaysia) SDN. BHD., through its existing subsidiary Helix Healthcare B.V. The Malaysian entity was established with an initial share capital of RM 400,000 (approx. USD 100,000). The primary objective is to expand Aurobindo's pharmaceutical products business in Malaysia, aligning with the company's global expansion strategy. The incorporation required no governmental or regulatory approvals and was completed through a 100% cash subscription.

11Sept 25

Aurobindo Pharma Shares Surge 6% as GTCR Nears €4.1 Billion Zentiva Acquisition

Aurobindo Pharma's shares closed 6% higher following reports that GTCR is close to acquiring Zentiva for €4.1 billion. GTCR has outbid other contenders, including Aurobindo Pharma, which had previously expressed interest in Zentiva. The deal is expected to be announced soon. Zentiva, currently owned by Advent International, operates in over 30 countries and employs more than 5,000 people.

08Sept 25

Aurobindo Pharma's Unit-XII Receives 8 Procedural Observations in US FDA Inspection

Aurobindo Pharma's Unit-XII facility underwent a US FDA inspection resulting in eight procedural observations. The company stated that these observations are not expected to have any significant impact on its operations or financial performance. Aurobindo Pharma assured stakeholders that both its financial standing and operational capabilities will remain unaffected by these findings.

05Sept 25

Aurobindo Pharma's Subsidiary Receives VAI Classification from US FDA for API Manufacturing Facility

Aurobindo Pharma's subsidiary, Apitoria Pharma Private Limited, has received an Establishment Inspection Report (EIR) with a Voluntary Action Indicated (VAI) classification from the US FDA for its Unit-2 API manufacturing facility in Telangana. The inspection was conducted from September 23 to 27. This follows a previous inspection at Aurobindo's Unit-XII facility, which resulted in eight procedural observations.

01Sept 25

Aurobindo Pharma Unit Completes FDA Inspection, Receives Form 483 with 5 Observations

Aurobindo Pharma announced the completion of an FDA inspection at its Unit-I facility, resulting in a Form 483 with five procedural observations. No data integrity issues were reported. The company will need to address these observations and provide a corrective action plan to the FDA.

30Aug 25

Aurobindo Pharma Receives FDA Form 483 with 5 Procedural Observations at Subsidiary's API Facility

The US FDA inspected Unit-I of Apitoria Pharma Private Limited, a subsidiary of Aurobindo Pharma, from August 21 to 29. The inspection resulted in a Form 483 with five procedural observations, with no data integrity concerns. Aurobindo Pharma will respond within the stipulated timeframe and affirms no impact on financials or operations. The company also announced an extension for the transfer of shares of CuraTeQ Biologics s.r.o. to September 30.

26Aug 25

Aurobindo Pharma's Subsidiary Secures UK Approval for Biosimilar Dazublys, Explores Zentiva Acquisition

Aurobindo Pharma's subsidiary, CuraTeQ Biologics, has received MHRA approval for its trastuzumab biosimilar, Dazublys, in the UK. This marks CuraTeQ's fourth biosimilar approval in the UK, with Dazublys also approved in the EU. The drug is indicated for HER2-positive breast and gastric cancers. Aurobindo Pharma is also in early talks to potentially acquire Zentiva, a European pharmaceutical company.

21Aug 25

Aurobindo Pharma in Early Talks for Potential Zentiva Acquisition

Aurobindo Pharma confirms preliminary discussions for acquiring Zentiva, a European pharmaceutical firm, potentially valued at $5.00-$5.50 billion. A Non-Disclosure Agreement has been signed. The deal aligns with Aurobindo's strategic plans for European expansion. An announcement could be made within two months if talks progress. Aurobindo's shares dropped 4.00% following initial reports. The company emphasizes its disciplined approach to acquisitions and dismisses debt concerns. No binding agreement has been made yet, and the company advises caution regarding premature news.

20Aug 25

Aurobindo Pharma Refutes $5.5 Billion Zentiva Acquisition Rumors

Aurobindo Pharma has officially denied reports of a $5.5 billion acquisition of Zentiva, a European generic drug manufacturer. The company stated that no binding agreement has been reached, countering widespread media speculation. This clarification is expected to impact market perceptions and investor sentiment. Aurobindo's swift response demonstrates its commitment to transparency and clear communication with investors.

20Aug 25

Aurobindo Pharma Eyes Record-Breaking $5.5 Billion Zentiva Acquisition

Aurobindo Pharma is in advanced negotiations to acquire Prague-based Zentiva from Advent International for an estimated $5-5.5 billion. The deal would be the largest acquisition by an Indian pharmaceutical firm. Aurobindo has secured a $4.75 billion credit line from MUFG and plans to contribute $800 million from internal funds. Zentiva operates in 30 countries with projected 2024 revenue of 1.70 billion euros and EBITDA of 400 million euros. The acquisition would significantly expand Aurobindo's presence in Eastern Europe and strengthen its position in the European generic drug market.

12Aug 25

FDA Approves Generic Iron Sucrose Versions, Posing Challenges for Dr. Reddy's and Aurobindo

The FDA has approved generic versions of Iron Sucrose from Viatris and Amphastar, potentially affecting Indian pharmaceutical companies like Dr. Reddy's Laboratories and Aurobindo Pharma. These approvals may reduce market opportunities for Indian players in the $512 million U.S. Iron Sucrose market. Despite this news, Dr. Reddy's and Aurobindo Pharma stocks showed slight gains.

08Aug 25

Aurobindo Pharma Reports 4% Revenue Growth in Q1 FY26, Resumes Pen-G Plant Operations

Aurobindo Pharma's consolidated revenues increased 4% YoY to ₹7,868.00 crores in Q1 FY26. EBITDA stood at ₹1,603.00 crores with a 20.4% margin. U.S. Formulations declined 4%, while European Formulations grew 9%. Growth Markets and ARV Formulations saw 9% and 55% growth respectively. API business declined 16%. The company launched 15 new products in the U.S., filed 4 ANDAs, and received 14 approvals. Net cash position improved to $140.00 million, and gross debt reduced to $884.00 million. Aurobindo announced the strategic acquisition of Lannett and received biosimilar approvals in Europe. The company maintains its EBITDA margin guidance of 20-21% for FY26.

06Aug 25

Aurobindo Pharma Sets Ambitious €1 Billion Europe Revenue Target for FY26

Aurobindo Pharma aims to exceed €1 billion in annual revenues from Europe by FY26. The company expects strong EBITDA performance from Q3, driven by its Production Linked Incentive (PLI) project. Aurobindo targets 7,000-8,000 tonnes production under PLI, estimating incentives of ₹150.00 crores. The company maintains an EBITDA margin outlook of 20-21% for FY26 and projects single-digit growth in coming years. More details will be shared in the November investor call.

04Aug 25

Aurobindo Pharma Reports Mixed Q1 Results with Revenue Growth and Profit Decline

Aurobindo Pharma's Q1 results show a 4% year-on-year revenue increase to ₹7,868.00 crore, driven by strong performance in Europe and Growth Markets. However, net profit declined 10.2% to ₹824.00 crore. US Formulations revenue fell 1.9%, while Europe Formulations grew 18%. The company filed 4 ANDAs and received 14 final approvals. An interim dividend of ₹4.00 per share was declared.

04Aug 25

Aurobindo Pharma Reports 4% Revenue Growth in Q1, Declares 400% Interim Dividend

Aurobindo Pharma announced Q1 financial results with consolidated revenue of ₹7,868.10 crore, up 4% year-over-year. PAT decreased 10.2% to ₹824.20 crore. Europe and Growth Markets showed strong performance, while US Formulations slightly declined. The company received 14 ANDA approvals and launched 15 products in the US. R&D expenses were 4.7% of revenues. The Board approved a 400% interim dividend (₹4 per share). Management highlighted steady performance and growth potential from recent US acquisition.

31Jul 25

Aurobindo Pharma Highlights Pharmaceutical Exemptions from Reciprocal Tariffs

Aurobindo Pharma has brought attention to the exemption of pharmaceutical products from reciprocal tariffs. This exemption could reduce trade barriers, enhance competitiveness, and ensure continued access to global markets for pharmaceutical companies. Additionally, Aurobindo Pharma USA Inc. has agreed to acquire Lannett Company LLC for $250 million, potentially strengthening its presence in the U.S. market, particularly in controlled substances and generic liquids.

30Jul 25

Aurobindo Pharma Restructures Biologics Business: Transfers Curateq Biologics Shares

Aurobindo Pharma has entered a binding agreement to transfer shares of Curateq Biologics s.r.o. from Helix Healthcare B.V. to Curateq Biologics B.V. for EUR 3,000,000. The transaction, set to complete by August 31, 2025, is part of Aurobindo's strategy to verticalize its biologics and biosimilars operations. Post-transaction, Curateq Biologics s.r.o. will become a wholly-owned subsidiary of Curateq Biologics B.V. The restructuring aligns with regulatory requirements and aims to streamline Aurobindo's biologics business for potential future growth.

30Jul 25

Aurobindo Pharma Restructures Biologics Business: Agrees to Transfer Curateq Biologics Shares

Aurobindo Pharma has entered into a binding agreement to transfer 100% stake in Curateq Biologics s.r.o. from Helix Healthcare B.V. to Curateq Biologics B.V. for €3 million. This move is part of the company's strategy to verticalize its biologics and biosimilars business under CuraTeQ Biologics Private Limited. The transaction, expected to complete by August 31, 2025, involves wholly owned subsidiaries and will have no impact on Aurobindo's consolidated financials. No regulatory approvals are required for this internal restructuring.

30Jul 25

Aurobindo Pharma Streamlines Biologics Business with €3 Million Internal Share Transfer

Aurobindo Pharma is restructuring its biologics business through an internal share transfer worth €3 million. The company will transfer 100% shares of CuraTeQ Biologics s.r.o. from Helix Healthcare B.V. to CuraTeQ Biologics B.V., all wholly owned subsidiaries. The restructuring, expected to complete by August 31, 2025, aims to verticalize the company's biologics and biosimilars operations under CuraTeQ Biologics Private Limited. This move is part of Aurobindo Pharma's strategy to streamline its biologics business and enhance operational efficiency.

23Jul 25

Aurobindo Pharma Set to Gain from Proposed Minimum Import Price on Key Pharma Inputs

The Indian government plans to implement minimum import prices for key pharmaceutical inputs. Aurobindo Pharma Ltd. is expected to be the biggest beneficiary among pharmaceutical companies if this policy is enacted. The move could reduce dependency on imports, improve profit margins for domestic manufacturers, and enhance Aurobindo Pharma's market position. The policy may also boost domestic production across the industry, potentially leading to supply chain restructuring and increased innovation in developing cost-effective alternatives.

15Jul 25

Aurobindo Pharma Expands Global Reach with Long-Lasting HIV Medication

Aurobindo Pharma has announced plans to produce and distribute long-lasting HIV medication in international markets. This strategic initiative aims to expand the company's global presence in the healthcare sector, particularly in HIV treatment. The move is expected to improve patient adherence to treatment regimens and potentially lead to better health outcomes for HIV patients worldwide. This development aligns with Aurobindo Pharma's goals of diversifying its product portfolio and strengthening its position in the global pharmaceutical industry.

03Jul 25

Aurobindo Pharma's European Breakthrough: EU Approval for Trastuzumab Biosimilar Dazublys

Aurobindo Pharma's subsidiary, CuraTeQ Biologics, has received marketing authorization from the European Commission for Dazublys, a biosimilar of Trastuzumab. Dazublys is approved for treating HER2-positive breast cancer and HER2-positive metastatic gastric cancer. This marks CuraTeQ's third EMA-approved biosimilar, aligning with Aurobindo's goal to launch 10 biosimilars by 2030. The approval is expected to expand Aurobindo's presence in the European biosimilars market and potentially increase revenue streams.

02Jul 25

Aurobindo Pharma's Subsidiary CuraTeQ Secures EU Approval for Cancer Drug Dazublys

Aurobindo Pharma's subsidiary, CuraTeQ Biologics, has received marketing authorization from the European Commission for its trastuzumab biosimilar, Dazublys. This approval allows the company to market the drug across the European Union for treating HER2-positive breast and gastric cancers. It marks CuraTeQ's third EMA-approved biosimilar and aligns with Aurobindo Pharma's goal to launch at least 10 biosimilars by 2030. This development is expected to strengthen Aurobindo's position in the European pharmaceutical market and potentially open new revenue streams.

30Jun 25

Aurobindo Pharma Resumes Penicillin Production at Kakinada Unit

Aurobindo Pharma has restarted penicillin production at its Kakinada unit following approval from the Andhra Pradesh Pollution Control Board (APPCB). This move is expected to boost the company's antibiotic manufacturing capabilities and strengthen its position in the antibiotics market. The resumption demonstrates Aurobindo's commitment to regulatory compliance and environmental standards, potentially leading to increased production capacity and revenue growth.

25Jun 25

Aurobindo Pharma's Subsidiary CuraTeQ Receives UK Approval for Biosimilar Dyrupeg

CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, has received marketing authorization from the UK's MHRA for Dyrupeg, a biosimilar of pegylated filgrastim. This marks CuraTeQ's third biosimilar approval in the UK, strengthening Aurobindo Pharma's presence in the British pharmaceutical market. Dyrupeg is used to reduce infection risk in cancer patients undergoing chemotherapy.

24Jun 25

Aurobindo Pharma's CuraTeQ Biologics Secures UK Approval for Cancer Treatment Biosimilar

CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, has received approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for its biosimilar Dyrupeg. This medication is used to treat neutropenia in cancer patients undergoing chemotherapy. Dyrupeg is CuraTeQ's third biosimilar to be approved in the UK, following Bevqolva and Zefylti. This approval strengthens Aurobindo Pharma's position in the growing biosimilars market and could potentially lead to additional revenue streams.

24Jun 25

Aurobindo Pharma's UK Subsidiary Secures Approval for Dyrupeg™

Aurobindo Pharma's subsidiary, CurateQ Biologics, has obtained approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for its product Dyrupeg™. This approval marks a significant milestone in Aurobindo Pharma's international expansion efforts, allowing the company to enter the UK pharmaceutical market. The MHRA approval indicates that Dyrupeg™ has met the required quality, safety, and efficacy standards for use in the United Kingdom. This development is expected to contribute to Aurobindo Pharma's market expansion, potential revenue growth, and demonstrates the company's regulatory expertise in navigating complex environments.

16Jun 25

Aurobindo Pharma Expands U.S. Presence with New Subsidiary 'Cresedemo Pharma LLC'

Aurobindo Pharma has created a new entity, 'Cresedemo Pharma LLC', in the United States to strengthen its presence in the U.S. pharmaceutical market. This strategic move aims to enhance Aurobindo's operations in one of the world's largest pharmaceutical markets. While specific operational details are not yet disclosed, the new entity is expected to play a crucial role in streamlining distribution, facilitating new product launches, enhancing market penetration, and improving regulatory compliance.

27May 25

Aurobindo Pharma Mulls Shareholder Returns Amid Strong Cash Flows

Aurobindo Pharma reported robust cash flows and is evaluating options to return value to shareholders, including a potential share buyback program or dividend distribution. The company generated Rs 2,434.50 crore from operating activities, a 2% increase year-over-year. Despite increased investing activities and decreased financing cash flows, Aurobindo maintains a strong operational cash generation, investing Rs 3,561.50 crore in capital expenditure. The company's board is actively considering shareholder return options, signaling confidence in its financial health.

27May 25

Aurobindo Pharma Sets Sights on Europe and Emerging Markets for FY26 Growth

Aurobindo Pharma has identified Europe and emerging markets as key drivers for revenue growth in fiscal year 2026. The company did not disclose specific growth targets but emphasized its strategic focus on these regions during a recent conference call. This approach aims to diversify geographical presence and tap into high-potential markets, potentially reducing dependence on any single market and providing opportunities for expansion.

26May 25

Aurobindo Pharma Sets Sights on US Biosimilars Market with FY26 FDA Submission Plan

Aurobindo Pharma plans to enter the US biosimilars market, targeting its first FDA submission in fiscal year 2026. The company is developing eight biosimilar candidates for a market projected to exceed $50 billion by 2030. This strategic move aims to diversify Aurobindo's portfolio, drive revenue growth, and strengthen its global position. However, the company faces regulatory hurdles, increasing competition, and manufacturing complexities in this venture.

26May 25

Aurobindo Pharma's Q4 Results: Revenue Up, Profit Flat, Misses Estimates

Aurobindo Pharma's Q4 results show a 10.65% increase in revenue to ₹8,382.00 crore, but net profit remained nearly flat at ₹903.50 crore, missing analysts' expectations. EBITDA improved by 7% to ₹1,792.00 crore, while the EBITDA margin slightly decreased to 21.40%. The company demonstrated strong sales performance but faced pressure on profit margins.

20May 25

USFDA Flags Quality Control Concerns at Aurobindo Pharma Facility

Aurobindo Pharma, a major Indian pharmaceutical company, is under USFDA scrutiny due to quality control issues at one of its facilities. The FDA inspection revealed inadequate documentation of quality control procedures and incomplete investigations of unexplained discrepancies. These findings could impact Aurobindo's regulatory compliance, necessitate quality assurance improvements, and potentially require significant remediation efforts.

14May 25

Aurobindo Pharma's Subsidiary Secures UK Approval for Biosimilar Zefylti

Aurobindo Pharma's subsidiary, Curateq Biologics, has received approval from the UK's Medicines and Healthcare products Regulatory Agency (MHRA) for its biosimilar product, Zefylti. This approval marks a significant milestone in Aurobindo's international expansion and strengthens its position in the biosimilar market. The approval is expected to facilitate market expansion in the UK, diversify Aurobindo's product portfolio, potentially increase revenue, and enhance its competitive position in the global biosimilar landscape.

30Apr 25

Aurobindo Pharma Faces ₹70.59 Million Tax Setback as Appeal Rejected

Aurobindo Pharma's appeal against a GST tax demand has been rejected by the Appellate Authority. The company now faces a total disputed amount of ₹70.59 million, including ₹37.45 million for Input Tax Credit reversal, ₹29.39 million in interest, and a ₹3.75 million penalty. The tax authorities allege excess Input Tax Credit claims and improper ITC claims from non-compliant suppliers. Aurobindo Pharma plans to appeal to the GST Appellate Tribunal and states the order has no material impact on its financials or operations.

29Apr 25

Aurobindo Pharma's Kakinada Facility Faces Temporary Shutdown After Fire Incident

Aurobindo Pharma reported a fire incident at its Kakinada facility on April 27, 2025, causing a temporary production halt for 20-25 days. The fire, caused by coal self-ignition, damaged ancillary equipment but left core manufacturing infrastructure intact. No injuries were reported. The facility is fully insured, and the company expects no material financial impact. Operations will resume after equipment replacement and safety protocol review.

28Apr 25

Aurobindo Pharma: Fire Incident and Positive CHMP Opinion for Biosimilar

Aurobindo Pharma experienced a fire at its penicillin-G facility in Kakinada SEZ, causing a 20-25 day operational pause. The company expects no material financial impact. On a positive note, Aurobindo's subsidiary, Curateq Biologics, received a favorable CHMP opinion for its trastuzumab biosimilar, Dazublys, for treating certain breast and gastric cancers in the EU. This marks a significant step towards potential EU market authorization and expansion in the biosimilars market.

26Apr 25

Aurobindo Pharma's Subsidiary Receives Positive CHMP Opinion for Trastuzumab Biosimilar

CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, has received a positive opinion from the CHMP recommending marketing authorization for Dazublys®, a trastuzumab biosimilar. The drug is intended for treating HER2-positive metastatic and early breast cancers. This marks the company's third biosimilar to receive CHMP endorsement. European Commission approval is expected in July, potentially making Dazublys® available across EU member states. Aurobindo Pharma aims to launch at least 10 biosimilars by 2030 in oncology and immunology therapy segments.

23Apr 25

Aurobindo Pharma's Subsidiary Secures FDA Nod for Lucrative Cancer Drug, Stock Rises

Aurobindo Pharma's subsidiary, Eugia Pharma Specialities Limited, has received FDA approval to manufacture and market Dasatinib tablets for leukemia treatment. The approval covers various strengths and is bioequivalent to Bristol-Myers Squibb's Sprycel Tablets. The product has an estimated market size of US$ 1.80 billion. Aurobindo plans to launch the tablets in Q1FY26. This marks Eugia Pharma's 181st ANDA approval, boosting Aurobindo's presence in the oncology market.

15Apr 25

Aurobindo Pharma Secures FDA Approval for Rivaroxaban Tablets, Tapping into $8.5 Billion US Market

Aurobindo Pharma has received FDA approval for its Rivaroxaban Tablets USP 2.5mg strength, with tentative approval for other strengths. This anticoagulant medication represents an $8.50 billion market opportunity in the US. The approval enhances Aurobindo's portfolio, increases revenue potential, and provides a competitive edge in the US pharmaceutical market.

13Apr 25

Aurobindo Pharma Secures FDA Approval for Generic Rivaroxaban, Targeting $8.5B Market

Aurobindo Pharma received FDA approval for generic Rivaroxaban 2.5mg tablets on April 12, 2025. The product is bioequivalent to Janssen's XARELTO®. Aurobindo plans to launch in Q1 FY2025-26, targeting a $447 million market. The company also has tentative approvals for 10mg, 15mg, and 20mg strengths, with a total market potential of $8.50 billion. This marks Aurobindo's 540th ANDA approval, reinforcing its position in the U.S. generic drug market.

11Apr 25

Aurobindo Pharma's US Subsidiary Receives 11 FDA Observations at Raleigh Facility

Aurobindo Pharma's US subsidiary, Aurolife Pharma LLC, received 11 procedural observations from the FDA following an inspection at its Raleigh, North Carolina facility. The inspection took place from March 24 to April 10, 2025. The company stated that these observations are not expected to significantly impact plant operations. Aurobindo Pharma plans to submit a comprehensive response within the stipulated timeline and implement corrective actions. The company maintains that there will be no material impact on current business operations or existing supplies from the Raleigh facility.