Lupin

Lupin Limited LUPN.NS:

• LUPIN AND TENPOINT THERAPEUTICS ANNOUNCE STRATEGIC PARTNERSHIP TO COMMERCIALIZE YUVEZZI™ IN THE EUROPEAN UNION, THE UNITED KINGDOM, SWITZERLAND, NORWAY, AND ICELAND

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Lupin received final U.S. FDA approval for Pitolisant Tablets in 4.45 mg and 17.8 mg strengths, bioequivalent to Wakix for the indications in the approved labeling. The approval expanded Lupin's U.S. product portfolio, which accounted for 42% of product sales in FY26. Lupin's FY26 net sales were about ₹27,500 crore. Recent U.S. approvals included sodium zirconium cyclosilicate on 10 August and Sugammadex and Diazepam injections on 31 July.

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Aug 17 (Reuters) - Lupin Limited LUPN.NS:

• ANNOUNCES APPROVAL FROM U.S. FDA FOR PITOLISANT TABLETS

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Lupin received U.S. FDA approval for sodium zirconium cyclosilicate for oral suspension in 5g and 10g packets, as a bioequivalent to AstraZeneca's Lokelma for treating hyperkalemia in adults. Lokelma had estimated annual U.S. sales of $568 million in the 12 months to June 2026. The U.S. accounted for 42% of Lupin's product sales in the first quarter of FY27. Lupin's FY26 net sales were about ₹27,500 crore.

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Aug 10 (Reuters) - ** Indian drugmaker Lupin LUPN.NS posted 16.1% Y/Y growth in Q1 consol net profit on Thursday, led by strong demand for its respiratory drugs

** Shares down ~4% at 2,276 rupees

STRONG Q1, U.S. RISKS PERSIST

** Bernstein ("Outperform," PT: 2,707 rupees) says Q1 validates its thesis that Lupin can sustain earnings despite U.S. erosion, helped by Apixaban, biosimilars, respiratory products and diversified growth across India, Europe and emerging markets

** BNP Paribas ("Neutral," PT: 2,590 rupees) says unchanged FY27 guidance despite the beat points to rising competition in Mirabegron and Tolvaptan, which could pressure margins and U.S. sales from Q2

** Jefferies ("Underperform," PT: 2,050 rupees) says earnings likely peaked in FY26 as U.S. quarterly sales normalize to $250-$280 million, with meaningful offsetting launches only from FY29

** Dolat Capital ("Reduce," PT: 2,480 rupees) says near-term U.S. moderation and higher costs constrain earnings growth despite healthy momentum in India and overseas markets

(Reporting by Kashish Tandon in Bengaluru)

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July 31 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - ANNOUNCES U.S. FDA APPROVAL AND LAUNCH OF SUGAMMADEX INJECTION IN THE UNITED STATES

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July 21 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN SPINS OUT TWO ONCOLOGY PROGRAMS TO KAVERI THERAPEUTICS TO ADVANCE ITS ONCOLOGY STRATEGY

• LUPIN - KAVERI TO OPERATE AS INDEPENDENT ENTITY LED BY CEO KRISTI JONES AND CMO ROBERT PIERCE

• LUPIN - KAVERI TO SEEK ADDITIONAL CAPITAL FOR CLINICAL DEVELOPMENT

• LUPIN: TO HAVE SIGNIFICANT EQUITY STAKE IN KAVERI, PROVIDE SEED FUNDING, AND GRANT THEM EXCLUSIVE RIGHTS TO PROGRAMS

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July 1 (Reuters) - Lupin Ltd LUPN.NS:

• ANNOUNCES EMA APPROVAL FOR NAMUSCLA

• ANNOUNCES EMA APPROVAL FOR NAMUSCLA PEDIATRIC INDICATION

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June 26 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN RECEIVES TENTATIVE APPROVAL FROM U.S. FDA FOR ENZALUTAMIDE TABLETS

Source text: ID:nPnZb4pya

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June 17 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN- LAUNCHES AZILSARTAN MEDOXOMIL TABLETS IN THE UNITED STATES

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June 8 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - COLLABORATES WITH LABORATORIOS ERN TO LAUNCH LUFORBEC (BECLOMETASONE/FORMOTEROL) PMDI IN SPAIN

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June 4 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN RECEIVES APPROVAL FROM U.S. FDA FOR RANLUSPEC™(RANIBIZUMAB) INJECTION

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May 28 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN’S ANKLESHWAR FACILITY RECEIVES EIR FROM U.S. FDA

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May 22 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - RECEIVES CHINA APPROVAL FOR OSELTAMIVIR PHOSPHATE ORAL SUSPENSION

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May 13 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - LUPIN RECEIVES U.S. FDA APPROVAL FOR FAMOTIDINE INJECTION, USP

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** India's Lupin LUPN.NS posted a profit of 14.6 billion rupees ($154.5 million) in Q4, up 89% Y/Y

** Shares of LUPN down ~4% to 2,364.3 rupees, after gaining about 5% in the previous two sessions ahead of earnings

STRONG U.S. MOMENTUM, INDIA RECOVERY

** Macquarie ("outperform", TP:2,460 rupees) sees strong visibility on co's upcoming U.S. launches and the resilience of its well-established domestic business

** Morgan Stanley ("equal-weight", TP:2,386 rupees) says Q4 results were driven by strong growth in its U.S. business due to new product launches and steady base business expansion; says India business resilient, supported by healthy growth in key therapies

** Nomura ("buy", PT:2,580 rupees) says margin expansion was supported favorable currency movements and a recovery in India growth, although overhead costs rose partly due to expenses related to the VISUfarma acquisition

($1 = 94.4725 Indian rupees)

(Reporting by Devika Nair in Bengaluru)

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May 7 (Reuters) - Lupin Ltd LUPN.NS:

• MARCH-QUARTER CONSOL NET PROFIT 14.6 BILLION RUPEES

• MARCH-QUARTER CONSOL TOTAL REVENUE FROM OPERATIONS 74.75 BILLION RUPEES

• DIVIDEND 18 RUPEES PER SHARE

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May 5 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - RECEIVES U.S. FDA APPROVAL FOR GLYCEROL PHENYLBUTYRATE ORAL LIQUID

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April 22 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN LAUNCHES DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS IN THE UNITED STATES

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April 17 (Reuters) - Lupin Ltd LUPN.NS:

• INCORPORATES WHOLLY OWNED SUBSIDIARY LUPIN (THAILAND) LIMITED IN THAILAND ON APRIL 17, 2026

Source text: ID:nBSE2RP5Bv

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April 10 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - LAUNCHES DAPAGLIFLOZIN TABLETS IN THE UNITED STATES

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April 8 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - RECEIVES U.S. FDA APPROVAL FOR DAPAGLIFLOZIN AND METFORMIN XR TABLETS

• LUPIN ANNOUNCES APPROVAL OF DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS IN THE UNITED STATES

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Lupin Ltd LUPN.NS:

• LUPIN - RECEIVES TENTATIVE APPROVAL FROM U.S. FDA FOR SUGAMMADEX INJECTION

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** Shares of Indian drugmaker Lupin LUPN.NS rise nearly 1% to 2366 rupees

** Co on Wednesday received tentative approval From U.S. FDA for Pitolisant tablets, to treat excessive daytime sleepiness in kids aged six and older people with narcolepsy

** Approval for Lupin's Pitolisant Tablets 4.45mg and 17.8 mg as bioequivalent to Wakix, co says

** More than 208,915 shares change hand by 11.11 am IST vs 30-day avg of 928,638 shares

** LUPN rated "buy" on avg by 35 analysts covering it; median PT at 2436 rupees

** YTD, LUPN up 11%

(Reporting by Komal Salecha in Bengaluru)

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March 25 (Reuters) - Lupin Ltd LUPN.NS:

• RECEIVES TENTATIVE FDA APPROVAL FOR PITOLISANT TABLETS

Source text: ID:nBSEcgVQqJ

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March 19 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - LUPIN MANUFACTURING SOLUTIONS ANNOUNCES EXPANSION OF MANUFACTURING FACILITY AT DABHASA, INDIA

• LUPIN - MANUFACTURING SOLUTIONS ANNOUNCES EXPANSION OF DABHASA FACILITY

Source text: ID:nBSE90Bc0x

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March 17 (Reuters) - Indian drugmakers Zydus Lifesciences ZYDU.NS and Lupin LUPN.NS have signed a licensing and supply deal on Tuesday to co‑market semaglutide injections in the country ahead of the ingredient's patent expiry.

Semaglutide is a GLP-1 receptor agonist used to treat Type 2 Diabetes and, increasingly, for weight management by helping regulate blood sugar and appetite.

The upcoming patent expiry for semaglutide has triggered a rush among Indian drugmakers to develop cheaper versions to capture market share in the world's most populous nation, which has the second-highest number of adults with diabetes after China.

Here are some key details:

• Lupin will have semi‑exclusive rights to co‑market Zydus' injection under the brand names Semanext and Lupin's Livarise.

• Lupin will pay Zydus upfront licensing fees and milestone-based payments.

• Zydus will manufacture the product at its Ahmedabad facility in Gujarat, and market the product under the brand names Semaglyntm, Mashematm And Alterme.

• Unlike existing treatments that require multiple single-use pens, Zydus' single-adjustable pen will allow patients select different doses, lowering costs.

• In January, Zydus received approval from India's regulator to make and sell generic versions of the weight-loss drugs.

• Larger peer Dr Reddy's Laboratories REDY.NS is likely to launch its generic semaglutide injection in March under the brand name Obeda, Reuters reported last month.

(Reporting by Urvi Dugar in Bengaluru; Editing by Sherry Jacob-Phillips)

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March 2 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - TAX DEPARTMENT CONCLUDES INSPECTION AT LUPIN'S REGISTERED OFFICE

• LUPIN - NO IMPACT ON LUPIN'S FINANCIALS FROM GST PROCEEDINGS

• LUPIN - NO ADVERSE FINDINGS ISSUED BY TAX DEPARTMENT TO CO

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Feb 27 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN RECEIVES EIR FROM US FDA FOR ITS GOA FACILITY

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Feb 25 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - TAX DEPARTMENT INITIATED INSPECTION AND SEARCH AT CO

• LUPIN - INSPECTION, SEARCH DOESN’T HAVE ANY IMPACT ON CO'S FINANCIALS, OPERATIONS

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