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Latest news about Lupin

Lupin's Dabhasa API Facility Secures TGA Australia GMP Certification 8 days ago

Lupin Limited's API facility in Dabhasa, Gujarat, operated by its subsidiary Lupin Manufacturing Solutions Limited, has received Good Manufacturing Practice (GMP) certification from Australia's Therapeutic Goods Administration (TGA). This certification validates Lupin's high-quality manufacturing standards and is expected to strengthen its position in the global pharmaceutical market, particularly in Australia and regions recognizing TGA certifications. The achievement aligns with Lupin's strategy to expand its global presence and reinforces its commitment to quality and compliance in pharmaceutical manufacturing.

Lupin's Pithampur Unit-2 Faces FDA Scrutiny: 4 Observations Issued 8 days ago

Lupin's Dabhasa API Facility Secures TGA Australia GMP Certification 9 days ago

Lupin Expands U.S. Portfolio with Launch of Loteprednol Etabonate Ophthalmic Suspension 10 days ago

Lupin Ltd. Sees Significant Block Trade on NSE Amidst ESG Rating Update Jul 11, 2025

More news about Lupin

10Jul 25

Lupin Ltd. Shares See Significant Block Trade of Rs. 30.84 Crores on NSE

A significant block trade of 163,326 Lupin Ltd. shares occurred on the National Stock Exchange (NSE), valued at Rs. 30.84 crores. The transaction was executed at Rs. 1,888.50 per share. While the parties involved remain undisclosed, such large trades can indicate strategic moves by major investors or institutions.

09Jul 25

Lupin Inks $60 Million Deal with Zentiva for Certolizumab Licensing

Lupin Limited has partnered with Zentiva for the licensing and supply of Certolizumab. The deal includes a $10 million upfront payment and potential earnings of up to $50 million in development and regulatory milestones. This strategic move aims to expand Lupin's product portfolio and strengthen its market position in the pharmaceutical industry, particularly in the autoimmune disease treatment sector.

04Jul 25

Lupin Expands U.S. Portfolio with Launch of Ipratropium Bromide Nasal Spray

Lupin Limited has introduced Ipratropium Bromide Nasal Spray in the United States market in 0.03% and 0.06% strengths. This anticholinergic medication is used to treat allergic and non-allergic rhinitis symptoms. The launch is expected to strengthen Lupin's position in the U.S. pharmaceutical market, diversify its product portfolio, and potentially increase its market share in the respiratory medication segment.

02Jul 25

Lupin Secures FDA Approval for Loteprednol Etabonate Ophthalmic Gel with 180-Day Exclusivity

Lupin Limited has received FDA approval for its Loteprednol Etabonate Ophthalmic Gel, granting the company a 180-day exclusivity period in the U.S. market. This corticosteroid gel, used for treating eye inflammation, presents a significant opportunity for Lupin to establish a strong market presence, potentially set favorable pricing, and gain valuable insights before competitors enter the market. The approval marks a milestone in Lupin's U.S. market strategy, particularly in the ophthalmic medication segment.

01Jul 25

Lupin Secures FDA Approval for Loteprednol Etabonate Eye Gel with 180-Day Exclusivity

Lupin has received FDA approval for Loteprednol Etabonate Eye Gel, granting them 180-day exclusive marketing rights in the United States. This approval expands Lupin's ophthalmic portfolio and provides a significant market opportunity. Loteprednol Etabonate is a corticosteroid used for post-operative inflammation and pain following ocular surgery.

01Jul 25

Lupin Spins Off Consumer Healthcare Business as LupinLife Consumer Healthcare Ltd

Lupin Limited has spun off its consumer healthcare business into a wholly owned subsidiary named LupinLife Consumer Healthcare Ltd, effective July 1. Anil Kaushal has been appointed as the CEO of the new entity. This strategic move aims to expand Lupin's presence in the over-the-counter (OTC) market, enhance focus on consumer healthcare, accelerate growth, and expand market presence. The spin-off is expected to diversify Lupin's revenue streams, provide access to a broader consumer base, and strengthen its brand presence among consumers.

30Jun 25

Lupin Restructures Operations: Transfers API R&D Division to Wholly Owned Subsidiary

Lupin Limited has executed an agreement to transfer its Active Pharmaceutical Ingredient (API) Research and Development division to a wholly owned subsidiary. This strategic restructuring aims to streamline research activities, potentially enhancing operational efficiency and focused management of research initiatives. The move could lead to more focused R&D efforts, increased operational flexibility, improved financial transparency for the API R&D segment, and a stronger strategic position in the pharmaceutical market, particularly in the API sector.

30Jun 25

Lupin to Shift OTC Business to LupinLife Consumer by 2025

Lupin Limited announced the transfer of its Over-The-Counter (OTC) business to its subsidiary, LupinLife Consumer, effective July 1, 2025. This strategic move aims to streamline operations, potentially allowing Lupin to focus on core pharmaceutical activities while enabling specialized management of the consumer health segment. The transfer may impact operational focus, brand management, and financial reporting for the company.

16Jun 25

Lupin Expands into Chinese Market with Tiotropium DPI Partnership

Lupin Limited has entered into a license and supply agreement with Sino Universal Pharmaceuticals for its Tiotropium Dry Powder Inhaler (DPI) product in China. This strategic move aims to introduce Lupin's respiratory medication for chronic obstructive pulmonary disease (COPD) to the Chinese market. The partnership leverages local expertise to navigate regulatory and distribution challenges, potentially opening new revenue streams for Lupin in one of the world's largest pharmaceutical markets.

05Jun 25

Lupin Secures Legal Victory in Mirabegron Case

Lupin has obtained legal relief concerning Mirabegron, a medication used to treat overactive bladder (OAB). While specific details are undisclosed, this victory could positively impact Lupin's operations and market presence. Mirabegron works by relaxing bladder muscles to increase capacity and treat symptoms like urinary urgency and frequent urination. The case's outcome may affect Lupin's ability to manufacture, market, or distribute Mirabegron-related products.

27May 25

Lupin to Showcase Oncology Research at ASCO 2025 with Phase 1 Data on LNP7457

Lupin Limited will present Phase 1 data on LNP7457, a new PRMT5 inhibitor, at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2025. This presentation marks a significant step in Lupin's oncology research, focusing on the safety, tolerability, and preliminary efficacy of the drug candidate. The development of LNP7457 reflects Lupin's strategic expansion into the oncology sector and could potentially open new avenues for cancer treatment.

26May 25

Lupin to Showcase Phase 1 Data on Novel Cancer Drug at ASCO 2025

Lupin Limited plans to present Phase 1 data on its cancer drug candidate LNP7457, a PRMT5 inhibitor, at the American Society of Clinical Oncology (ASCO) Annual Meeting in 2025. This milestone marks Lupin's progress in oncology research and its entry into targeted cancer therapies. The presentation at ASCO, a prestigious oncology conference, indicates the advancement of Lupin's research to human trials and showcases the company's commitment to expanding its presence in the oncology market.

26May 25

Lupin Expands Footprint in Latin America with Biosimilar Ranibizumab Deal

Lupin Ltd has entered a strategic agreement with SteinCares for the supply and commercialization of biosimilar Ranibizumab in Latin America, excluding Mexico and Argentina. Lupin will manufacture the biosimilar, while SteinCares will handle regulatory filings and commercialization. Ranibizumab is used to treat various retinal conditions including age-related macular degeneration and diabetic macular edema. This partnership aims to expand Lupin's biosimilar portfolio and geographical reach in the Latin American market.

23May 25

Lupin Restructures $44.3M Debt to Equity in Oncology Subsidiary

Lupin Inc. USA, a subsidiary of Lupin Limited, has converted a $41 million loan and $3.3 million in outstanding interest into equity in Lupin Oncology Inc., USA. This $44.3 million debt-to-equity conversion is expected to strengthen Lupin Oncology's balance sheet, increase Lupin Inc. USA's stake in the oncology unit, and provide greater financial flexibility for the cancer-focused subsidiary.

20May 25

Lupin Partners with Honeywell for Eco-Friendly Inhaler Technology

Lupin Ltd. has announced a partnership with Honeywell to introduce an environmentally friendly propellant, Solstice Air, for its next-generation inhalers. This technology is expected to reduce carbon emissions by up to 99.90% compared to traditional HFC-based propellants. Lupin aims to be the first Indian pharmaceutical company to use this propellant at scale in its pressurized metered-dose inhalers for asthma and COPD patients.

16May 25

Lupin Targets Sustainable Double-Digit Growth, Aims to Outpace Market

Lupin Limited announces strong growth projections and margin enhancements. EBITDA margins now align with industry peers and are expected to improve further. The company targets quarterly revenues exceeding $250 million and aims to outpace market growth by 20-30%. Lupin is positioning itself for sustainable double-digit growth, reflecting confidence in its product portfolio and market strategy.

15May 25

Lupin Secures FDA Approval for Rivaroxaban Tablets and Reports Strong Q4 Results

Lupin Limited has received FDA approval for Rivaroxaban Tablets in 10 mg, 15 mg, and 20 mg strengths, entering a U.S. market worth $8 billion annually. The company also reported impressive Q4 financial results with a 12.20% increase in revenue to ₹5,567.10 crore and a 121.10% surge in profit to ₹794.86 crore. U.S. sales reached $245 million, up from $209 million in the previous year.

15May 25

Lupin's Q4 Profit Soars, Revenue Climbs Amid Strong Financial Performance

Lupin reported impressive Q4 FY2025 results with consolidated net profit surging 121.10% YoY to ₹794.86 crore. Revenue increased by 12.20% to ₹5,567.10 crore, while EBITDA grew 22.50% to ₹996.85 crore. North American market performance was strong, with US sales reaching $245.00 million, up from $209.00 million the previous year. The results indicate Lupin's strengthening market position and effective business strategies in the pharmaceutical sector.

13May 25

Lupin Launches Tolvaptan Tablets in U.S. Market with 180-Day Exclusivity

Lupin Limited has introduced Tolvaptan tablets in the United States market with a 180-day exclusivity period. Tolvaptan, used to treat hyponatremia and slow kidney function decline in ADPKD, has reported U.S. sales of $1.50 billion. This launch positions Lupin as the sole generic provider for six months, potentially leading to significant revenue and market share gains in a billion-dollar market.

08May 25

Lupin Secures FDA Approval for Raltegravir Tablets, Gains 180-Day Exclusivity

Lupin Limited has received FDA approval for Raltegravir Tablets USP, 600 mg, an antiretroviral medication for HIV treatment. As the exclusive first-to-file applicant, Lupin gains 180-day generic drug exclusivity in the U.S. market. This approval is expected to boost Lupin's revenue, strengthen its market position in the U.S. generic drug sector, and provide a competitive edge in the HIV treatment segment.

08May 25

Lupin Launches Generic Eslicarbazepine Acetate Tablets in U.S., Tapping into $395 Million Market

Lupin Limited has introduced generic Eslicarbazepine Acetate Tablets in the United States, targeting a market with $395 million annual sales potential. The company has secured 180 days of shared generic exclusivity, positioning itself to capture significant market share in the competitive U.S. generics market.

07May 25

Lupin Launches Generic Eslicarbazepine Acetate Tablets in U.S., Eyeing $395 Million Market

Lupin Limited has introduced generic Eslicarbazepine Acetate Tablets in the United States, entering a market with an estimated annual value of $395.00 million. The company has been granted 180 days of shared generic exclusivity for this antiepileptic drug, which is used to treat partial-onset seizures. This launch represents a significant opportunity for Lupin to expand its U.S. portfolio and potentially capture a considerable market share in the competitive pharmaceutical landscape.

24Apr 25

Lupin Secures FDA Approval for Tolvaptan, Eyeing $1.5B Market with Exclusivity

Lupin Limited has received FDA approval for its generic version of Tolvaptan tablets in multiple strengths. As the exclusive first-to-file applicant, Lupin has secured a 180-day generic drug exclusivity. The tablets, bioequivalent to Otsuka's Jynarque®, are used to treat autosomal dominant polycystic kidney disease. Analysts project potential revenue of $150-200 million in FY26, contributing over 25% to the company's earnings. The product will be manufactured at Lupin's Nagpur facility and launched soon.

23Apr 25

Lupin Diagnostics Achieves Full NABL Accreditation, Solidifying Position in Indian Diagnostic Sector

Lupin Diagnostics, a subsidiary of Lupin Limited, has obtained National Accreditation Board for Testing and Calibration Laboratories (NABL) accreditation for all 27 of its greenfield laboratories. This achievement positions the company among India's top fully accredited diagnostic chains. The accreditation ensures high-quality standards and reliable test results. Lupin Diagnostics has also received several industry awards, including 'Patient-Centric Diagnostic Laboratories Company of the Year' and 'Emerging Diagnostics Chain of the Year'. The company offers over 3,000 tests and operates a 45,000 sq. ft. National Reference Laboratory in Navi Mumbai.

17Apr 25

Lupin Receives FDA Approval for Nagpur Facility Amid Patent Litigation

Lupin Limited received FDA approval for its Nagpur facility for drug-device combination products. Simultaneously, the company faces a setback in patent litigation with Astellas Pharma Inc. over generic Mirabegron products, with a Delaware court ruling in favor of Astellas. Lupin maintains there are no material financial implications and is considering further legal action. A consolidated jury trial is scheduled for 2026.

16Apr 25

Lupin Faces Setback in Patent Litigation for Myrbetriq Drug

Lupin Limited and Zydus lost a patent litigation case in the Federal Circuit court regarding the overactive bladder drug Myrbetriq. The court ordered both companies to withdraw their versions of the medication from the market. This ruling is expected to result in financial penalties for Lupin, including legal expenses and potential damages. The market withdrawal will impact Lupin's product portfolio and revenue projections in the overactive bladder treatment segment. This case highlights the challenges faced by generic drug manufacturers in navigating pharmaceutical patents and emphasizes the need for robust patent strategies and thorough legal due diligence.

02Apr 25

Lupin Expands UK Presence: Acquires Renascience Pharma for £12.3 Million

Lupin Healthcare (UK) Limited has acquired Renascience Pharma Limited for £12.30 million, expanding its specialty pharmaceutical portfolio in the UK market. The acquisition brings four specialty products targeting unmet medical needs, including treatments for non-viral infectious diseases, pain management, and cardiology/nephrology indications. Two lead products, XAQUA and OTIGO, currently face no generic competition in the UK. This strategic move aligns with Lupin's transition towards becoming a more specialized pharmaceutical organization.

02Apr 25

Lupin Ltd. Shares See Major Block Trade Worth Rs. 40.48 Crores on NSE

A significant block trade of 201,611 Lupin Ltd. shares was executed on the National Stock Exchange (NSE) at ₹2,007.75 per share, totaling ₹40.48 crore. This large transaction indicates potential institutional activity and demonstrates strong liquidity in Lupin's stock.

31Mar 25

Lupin Restructures: API R&D Division Transfer and OTC Business Modification

Lupin Limited is transferring its API R&D division to subsidiary LMSL for ₹175-225 million, and modifying its OTC Consumer Healthcare Business transfer to LCHL for ₹8,000-9,000 million. The API R&D division transfer, valued at ₹191.70 million net worth, is expected to complete by April 2025. The expanded OTC business transfer, now including an additional brand, represents ₹2,003 million in revenue and ₹1,680 million in net worth. Both moves aim to streamline operations and enhance market position, with completion expected by June 2025.

24Mar 25

Lupin's Digital Health Division Launches Innovative Post-Cardiac Procedure Care Guide

Lupin Limited's Digital Health division has introduced a comprehensive home-based care guide for patients recovering from cardiac procedures. Developed in collaboration with the American College of Cardiology, this guide aims to enhance post-operative care and improve patient recovery. The initiative is designed to empower patients, reduce complications, improve outcomes, and ease the transition from hospital to home care.

17Mar 25

Lupin Secures Tentative FDA Approval for Amifampridine Tablets, Eyeing $306 Million Market

Lupin Limited has received tentative approval from the U.S. FDA for its Amifampridine tablets, used to treat Lambert-Eaton myasthenic syndrome. The global market for this product is estimated at $306 million. This approval marks a significant step for Lupin in expanding its presence in the U.S. pharmaceutical market, particularly in specialty and complex generics. The company now awaits final FDA approval before commercialization.

10Mar 25

Lupin to Launch Affordable Generic Empagliflozin, Boosting Diabetes Care Accessibility in India

Lupin Limited is set to launch a generic version of empagliflozin, a crucial diabetes medication, at a significantly reduced price. The generic drug is expected to cost between Rs 9 to Rs 14 per tablet, compared to the current branded version's price of Rs 60 per tablet. This move, part of a broader initiative by Indian pharmaceutical companies, aims to improve accessibility and affordability of diabetes treatment for millions of patients in India. The dramatic price reduction could lead to improved treatment adherence and lower overall diabetes management costs.

07Mar 25

Lupin Expands U.S. Portfolio with Launch of Rivaroxaban Tablets

Lupin Limited has launched Rivaroxaban Tablets USP, 2.5mg, in the United States following FDA approval. The generic equivalent of Xarelto® has estimated annual sales of USD 446 million in the U.S. The medication is used to reduce cardiovascular risks in patients with coronary artery disease and peripheral artery disease.

21Feb 25

Lupin's Somerset Facility Receives Clean Bill of Health from U.S. FDA

Lupin Limited has received the Establishment Inspection Report (EIR) from the U.S. FDA for its Somerset, New Jersey manufacturing facility following an inspection from January 27-31, 2025. This signifies successful closure of the FDA inspection and validates Lupin's commitment to quality standards. Managing Director Nilesh Gupta expressed satisfaction with the outcome, highlighting its importance for the company's position in the pharmaceutical industry.