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Latest news about Aurobindo Pharma

Aurobindo Pharma Resumes Penicillin Production at Kakinada Unit 1 day ago

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.

Aurobindo Pharma's Subsidiary CuraTeQ Receives UK Approval for Biosimilar Dyrupeg 6 days ago

Aurobindo Pharma's CuraTeQ Biologics Secures UK Approval for Cancer Treatment Biosimilar 7 days ago

Aurobindo Pharma's UK Subsidiary Secures Approval for Dyrupeg™ 7 days ago

Aurobindo Pharma Expands U.S. Presence with New Subsidiary 'Cresedemo Pharma LLC' Jun 16, 2025

More news about Aurobindo Pharma

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.