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Latest news about Aurobindo Pharma

Aurobindo Pharma Promoters Secure Rs 2,000 Crore for Real Estate Ventures 5 days ago

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.

Aurobindo Pharma's Hyderabad Unit Under US FDA Scrutiny Oct 07, 2025

Aurobindo Pharma Completes Internal Restructuring: CuraTeQ Biologics Ownership Transferred Oct 01, 2025

Aurobindo Pharma Extends Deadline for Subsidiary Share Transfer and Establishes New Entity in Malta Sep 26, 2025

Aurobindo Pharma Extends Timeline for 26% Stake Acquisition in Swarnaakshu Solar Power Sep 26, 2025

More news about Aurobindo Pharma

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.

11Apr 25

Aurobindo Pharma's Subsidiary Advances in Denosumab Biosimilar Development

Aurobindo Pharma's subsidiary, Curateq Biologics, has successfully completed a Phase 1 pharmacokinetics study for BP16, a proposed biosimilar to denosumab (Prolia® and Xgeva®). This marks a significant milestone in the company's biosimilar development program for osteoporosis and bone loss treatments. The completion of this initial study positions Aurobindo Pharma as a potential key player in the biosimilars market for bone health treatments, with further clinical trials and assessments still required.

09Apr 25

Aurobindo Pharma's CuraTeQ Biologics Achieves Milestone in Denosumab Biosimilar Development

CuraTeQ Biologics, a subsidiary of Aurobindo Pharma, has successfully completed a Phase 1 study for BP16, a biosimilar to denosumab (Prolia® and Xgeva®). The study involving 204 healthy volunteers showed BP16's pharmacokinetic profile to be nearly identical to the reference products, meeting key bioequivalence parameters. The company is now progressing with a Phase 3 study in the EU, focusing on postmenopausal osteoporosis, with anticipated completion by May/June 2025. CuraTeQ aims to submit a Marketing Authorization application to CHMP/EMA in Q3 of the fiscal year.

19Mar 25

Aurobindo Pharma Subsidiary Receives VAI Classification from US FDA

Aurobindo Pharma's subsidiary, Apitoria Pharma Private Limited, received a 'Voluntary Action Indicated' (VAI) classification from the FDA for its Unit-V API manufacturing facility in Telangana after an inspection from December 9-17, 2024. The VAI status suggests minor issues that don't require regulatory action. Separately, shareholders approved the re-appointment of Mr. Santanu Mukherjee as an Independent Director for a 5-year term with 91.02% votes in favor.

05Mar 25

Aurobindo Pharma Ends License Agreement with Hilleman Laboratories, Signaling Strategic Shift

Aurobindo Pharma Limited has officially terminated its license agreement with Hilleman Laboratories Singapore, potentially signaling a shift in its research and development strategy. The termination could impact the company's product pipeline and future collaborations. Separately, Aurobindo Pharma has scheduled an investor meeting for March 12, 2025, in Hyderabad, arranged by Macquarie.

03Mar 25

Aurobindo Pharma Expands Biotech Presence with 80% Stake Acquisition in Tergene Biotech

Aurobindo Pharma has completed the acquisition of an 80% stake in Tergene Biotech, a step-down subsidiary and joint venture company. This strategic move aims to strengthen Aurobindo's position in the biotech sector, potentially expanding its capabilities, diversifying its portfolio, and enhancing its market presence in biotechnology.

28Feb 25

Aurobindo Pharma Completes Acquisition of 80% Stake in Tergene Biotech

Aurobindo Pharma has completed the acquisition of an 80% stake in Tergene Biotech Limited for Rs. 107.6 million, transforming it from a step-down subsidiary into a direct subsidiary. The transaction, approved on February 6, 2025, and completed on February 28, 2025, is expected to strengthen Aurobindo's position in the biotech sector, potentially enhancing its capabilities in biotechnology research, vaccine development, and expanding its product pipeline.

20Feb 25

Aurobindo Pharma's US Subsidiary Faces FDA Scrutiny: New Jersey Warehouse Receives 'Official Action Indicated' Classification

Aurobindo Pharma's US subsidiary warehouse in New Jersey has been classified as 'Official Action Indicated' (OAI) by the US FDA following an inspection from May 13-15, 2024. The inspection, focused on Drug Supply Chain Security Act compliance, resulted in five observations. Despite this, the company doesn't foresee any immediate business impact and commits to working closely with the FDA to enhance compliance measures.