LUPIN

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

Further company coverage: LUPN.NS

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Feb 24 (Reuters) - Lupin Ltd LUPN.NS:

• RECEIVES FDA APPROVAL FOR BRIVARACETAM ORAL SOLUTION

Source text: ID:nBSE2nrh2j

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Feb 23 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - RECEIVES EUROPEAN COMMISSION APPROVAL FOR BIOSIMILAR RANIBIZUMAB

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** Shares of India's Lupin LUPN.NS rise 1.35% to 2249.80 rupees

** Drugmaker signs license and supply agreement with Spektus Pharma to commercialize antidepressant Deslaflex in Canada

** Co says deal expands Lupin's central nervous system (CNS) portfolio in the Canadian market

** Trading vols at 424,238 shares vs 30-day-avg of 873,939 shares

** Stock rated "buy" on avg by 35 analysts, median PT at 2421.50 rupees

** LUPN dropped 10.45% in 2025, stock gained 5.3% so far in 2026

(Reporting by Surbhi Misra in Bengaluru)

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Repeats story from 13th Feburary with no changes to text

By Rishika Sadam

Feb 16 (Reuters) - Biocon BION.NS is aiming for high-double-digit percentage revenue growth as the Indian pharmaceutical firm prepares to launch generic versions of weight-loss drugs globally even as it remains cautious about an early rollout in the home market, a top company executive told Reuters.

The company is counting on demand for obesity medicines as it expands a pipeline that includes copycat versions of Novo Nordisk's NOVOb.CO Wegovy, whose patent for semaglutide in a few markets expires in 2026.

Indian drugmakers, including Dr Reddy's REDY.NS, Lupin LUPN.NS, Sun Pharmaceutical SUN.NS and at least half a dozen others are racing to bring cheaper copies to markets once the active compound goes off patent.

Bengaluru-based Biocon is targeting a U.S. launch of generic liraglutide in the first quarter of the next financial year, CEO Siddharth Mittal said in an interview on Friday. Liraglutide is also used for obesity treatment.

It aims to launch generic Wegovy in Canada next year, subject to regulatory approval, Mittal said. It is also planning launches over the next few years in India, Brazil, Mexico, Turkey, and parts of the Middle East and Latin America.

The company, however, is cautious about an early start in India due to fierce price competition and local clinical trial requirements, Mittal said.

"There's going to be fierce competition in India," Mittal said, citing low price expectations. He said Biocon is exploring approval in a specific overseas market first, which could help it seek a clinical trial waiver in India under local rules.

In India, Biocon would need to run a late-stage clinical trial before launch. The company is weighing whether that cost would be justified, Mittal said, or whether it should seek a waiver.

The obesity medicines market, according to several forecasts, is expected to reach at least $150 billion globally by the early 2030s, and analysts expect generic versions to be priced at least 60% below the originator products.

Biocon expects high double-digit percentage revenue growth, Mittal said. The company's annual revenue grew 5.4% in fiscal 2025 from a year ago, but it has been growing in early double-digits on a quarter-on-quarter basis.

India is not Biocon's main market. The company derives significant share of revenue from the United States and parts of Europe.

(Reporting by Rishika Sadam; Editing by Tasim Zahid)

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By Rishika Sadam

Feb 13 (Reuters) - Biocon BION.NS is aiming for high-double-digit percentage revenue growth as the Indian pharmaceutical firm prepares to launch generic versions of weight-loss drugs globally even as it remains cautious about an early rollout in the home market, a top company executive told Reuters.

The company is counting on demand for obesity medicines as it expands a pipeline that includes copycat versions of Novo Nordisk's NOVOb.CO Wegovy, whose patent for semaglutide in a few markets expires in 2026.

Indian drugmakers, including Dr Reddy's REDY.NS, Lupin LUPN.NS, Sun Pharmaceutical SUN.NS and at least half a dozen others are racing to bring cheaper copies to markets once the active compound goes off patent.

Bengaluru-based Biocon is targeting a U.S. launch of generic liraglutide in the first quarter of the next financial year, CEO Siddharth Mittal said in an interview on Friday. Liraglutide is also used for obesity treatment.

It aims to launch generic Wegovy in Canada next year, subject to regulatory approval, Mittal said. It is also planning launches over the next few years in India, Brazil, Mexico, Turkey, and parts of the Middle East and Latin America.

The company, however, is cautious about an early start in India due to fierce price competition and local clinical trial requirements, Mittal said.

"There's going to be fierce competition in India," Mittal said, citing low price expectations. He said Biocon is exploring approval in a specific overseas market first, which could help it seek a clinical trial waiver in India under local rules.

In India, Biocon would need to run a late-stage clinical trial before launch. The company is weighing whether that cost would be justified, Mittal said, or whether it should seek a waiver.

The obesity medicines market, according to several forecasts, is expected to reach at least $150 billion globally by the early 2030s, and analysts expect generic versions to be priced at least 60% below the originator products.

Biocon expects high double-digit percentage revenue growth, Mittal said. The company's annual revenue grew 5.4% in fiscal 2025 from a year ago, but it has been growing in early double-digits on a quarter-on-quarter basis.

India is not Biocon's main market. The company derives significant share of revenue from the United States and parts of Europe.

(Reporting by Rishika Sadam; Editing by Tasim Zahid)

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Adds stock prices in paragraph 4

Feb 12 (Reuters) - India's Zydus Lifesciences ZYDU.NS and its U.S. unit will pay $120 million to Astellas Pharma 4503.T as part of a deal to settle a patent dispute over the Japanese drugmaker's bladder disorder drug Mirabegron, the Indian firm said on Thursday.

Zydus and its unit will also pay a pre-paid per‑unit licensing fee on sales of its generic Mirabegron in the U.S. from the date of the agreement until September 2027, the company said.

The deal will enable the company to continue marketing its generic Mirabegron in the United States, Zydus said, adding that other terms and conditions of the agreement are confidential.

Shares of Zydus climbed as much as 1.3% shortly after the announcement.

The announcement comes days after local peer Lupin LUPN.NS decided to settle its dispute with Astellas over the same drug for $90 million.

At that time, analysts at brokerage Citi said the development could delay the entry of other generic rivals in the U.S. market, potentially providing Zydus and Lupin with a period of limited competition.

(Reporting by Hritam Mukherjee in Bengaluru; Editing by Sherry Jacob-Phillips)

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Adds Astellas' comment in paragraph 3, analyst comment in paragraph 5, share move in paragraph 6

Feb 10 (Reuters) - Indian drugmaker Lupin LUPN.NS said on Tuesday it agreed to a $90 million settlement with Japan's Astellas Pharma 4503.T in a patent dispute over the bladder disorder drug Mirabegron, a move that allows it to continue selling the product in the United States.

Under the agreement, Lupin and its U.S. unit will pay Astellas a $75 million upfront payment and per-unit licensing fees on Mirabegron sales through September 2027, the company said in an exchange filing.

In a separate statement, the Japanese drugmaker said the settlement concludes its litigation with Lupin and added that it is reviewing the potential financial impact for the fiscal year ending March 31, 2026.

Lupin had previously disclosed the patent dispute with Astellas last April over its generic version of Myrbetriq, Astellas' overactive bladder drug, after a U.S. court ruling raised the risk that generic versions could be withdrawn from the market.

Citi analysts said the settlement removes legal uncertainty around Lupin's Mirabegron sales in the U.S. and could delay the entry of other generic rivals, potentially providing Lupin and Zydus Lifesciences ZYDU.NS, another drugmaker involved in the litigation, with a period of limited competition.

Lupin's shares were trading up 0.91%, as of 11:01 am IST.

(Reporting by Surbhi Misra and Vivek Kumar M in Bengaluru; Editing by Sherry Jacob-Phillips)

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

• LUPIN - LAUNCHES TOPIRAMATE EXTENDED-RELEASE CAPSULES IN U.S.

Source text: ID:nBSE79Kl58

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

• LAUNCHES DASATINIB TABLETS IN THE UNITED STATES

Source text: ID:nnAZN4S7KLI

Further company coverage: LUPN.NS

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

• LUPIN - LUPIN AND GALENICUM SIGN LICENSE AND SUPPLY AGREEMENT FOR SEMAGLUTIDE IN 23 COUNTRIES

• LUPIN - GALENICUM TO OVERSEE DEVELOPMENT, LUPIN TO HANDLE COMMERCIALIZATION

• LUPIN - AGREEMENT COVERS 23 COUNTRIES INCLUDING CANADA AND EUROPE

Source text: ID:nBSE3r0Rd

Further company coverage: LUPN.NS

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Dec 29 (Reuters) - Lupin Ltd LUPN.NS:

• SIGNS EXCLUSIVE LICENSING AGREEMENT WITH GAN & LEE PHARMACEUTICALS FOR NOVEL GLP-1 RECEPTOR AGONIST

Source text: ID:nNSE2BTscP

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Dec 19 (Reuters) - Biomarin Pharmaceutical Inc BMRN.O:

• BIOMARIN TO ACQUIRE AMICUS THERAPEUTICS FOR $4.8 BILLION, EXPANDING POSITION AS A LEADER IN RARE DISEASES, ACCELERATING REVENUE GROWTH AND STRENGTHENING FINANCIAL OUTLOOK

• AMICUS THERAPEUTICS INC - BIOMARIN TO BUY AMICUS FOR $14.50 PER SHARE IN CASH

• AMICUS THERAPEUTICS INC - BIOMARIN TO FINANCE DEAL WITH CASH AND $3.7 BILLION DEBT

• AMICUS THERAPEUTICS INC: DEAL EXPECTED TO BE ACCRETIVE TO NON-GAAP DILUTED EARNINGS PER SHARE IN FIRST 12 MONTHS POST-CLOSE

• AMICUS THERAPEUTICS INC: PENDING U.S. GALAFOLD IP LITIGATION RESOLVED

• AMICUS THERAPEUTICS : DEAL SUBSTANTIALLY ACCRETIVE TO NON-GAAP DILUTED EPS BEGINNING IN 2027 TO BIOMARIN

• AMICUS THERAPEUTICS: ENTERED LICENSE AGREEMENTS WITH AUROBINDO & LUPIN FOR GALAFOLD 123 MG CAPSULES

• AMICUS THERAPEUTICS: TO GRANT AUROBINDO AND LUPIN LICENSES TO MARKET GENERIC VERSIONS OF GALAFOLD IN US FROM JAN 30, 2037

Source text: ID:nPn6mkX9xa

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Dec 16 (Reuters) - Lupin Ltd LUPN.NS:

• RECEIVES EIR FROM US FDA FOR NAGPUR FACILITY

Source text: ID:nBSE6KS4CK

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Repeats Friday's story without changes

By Aditya Kalra, Nikunj Ohri and Shivam Patel

NEW DELHI, Dec 12 (Reuters) - India and France have struck a deal to revise their 1992 treaty which will halve the tax on dividends paid by Indian units to French parents, potentially saving millions for companies with major operations in the South Asian nation, documents show.

In return, India will get to widen its powers to tax share sales by French investors, and revoke the "most favoured nation" status of France that gave it certain tax advantages, according to confidential Indian government documents reviewed by Reuters.

Bilateral trade between India and France stood at $15 billion last year, and Indian Prime Minister Narendra Modi and French President Emmanuel Macron have been forging warmer ties. The two sides have been working to recast their tax treaty since 2024 to modernize it by adapting global standards on tax transparency.

"The proposed amending protocol will boost flow of investment, technology and personnel between India and France, and will provide tax certainty," said one of the Indian government documents from August.

The new treaty could have implications for large French portfolio investors as well as companies like Capgemini CAPP.PA, Accor ACCP.PA, Sanofi SASY.PA, Pernod Ricard PERP.PA, Danone DANO.PA and L'Oreal OREP.PA -- all of which have expanded their presence in India in recent years.

A key change is that French companies which hold a stake of more than 10% in any Indian entity will have to pay a 5% tax on the dividends they receive, instead of 10% earlier.

For minority French shareholdings of under 10% in Indian companies, however, dividend tax will rise from 10% to 15%.

Many French firms' Indian units like Capgemini Technology Services India, BNP Paribas Securities India and TotalEnergies Marketing India have declared dividends in the past, their Indian regulatory disclosures show. The Capgemini CAPP.PA unit's dividend stood at $500 million in 2023-24.

France's tax office said it could not comment for this story given the negotiations are ongoing, while the finance ministry did not respond to Reuters' queries.

India's foreign and finance ministries also did not respond.

Capgemini and Danone declined to comment while the other French companies did not respond to Reuters' queries.

CHANGES TO CAPITAL GAINS, SERVICES TAX

Currently, India can impose taxes on any French entity's share sale, but only when it holds more than 10% of an Indian company. The new proposed treaty will remove that threshold.

The new treaty "will provide for full source-based taxation rights in respect of capital gains on equity shares (in India)," said the Indian documents.

France-based foreign portfolio investors (FPIs) own $21 billion worth of shares in Indian companies as of November 2025, a third higher than levels in 2024, Indian share depository data shows.

And more than 40 French companies hold stakes of under 10% in Indian entities, according to an analysis by Indian market intelligence platform Tracxn.

"This will impact French FPIs in India and also French companies holding minority interest in Indian companies. These investments were not subject to tax under the current treaty," said Riaz Thingna, a partner at Grant Thornton Bharat LLP.

One official familiar with the deliberations told Reuters on condition of anonymity that Indian and French officials have agreed the terms of the new treaty, which will likely be signed in the coming weeks.

In New Delhi, the deal is subject to final approval by Prime Minister Narendra Modi's cabinet, according to the documents.

Reuters is the first to report the planned changes to India-France treaty.

India has also agreed to France's demand to limit tax on fees for technical services to cases where a French provider transfers technical know-how, removing most routine consultancy and support services from the scope of India's tax.

"This can help French companies that render services like design consultancy, cybersecurity and market research," Thingna said.

NO MORE 'MOST FAVOURED NATION'

Differences over how to interpret the so-called most-favoured nation, or MFN, clause were among the main reasons for the renegotiation, the official said.

If a country has an MFN clause with India under a signed treaty, it typically starts claiming lower tax rates if New Delhi strikes more favourable tax terms later with another OECD nation.

But a landmark Indian Supreme Court decision in late 2023 said countries can't automatically start doing so, triggering concerns in France.

"This decision led to a sharp deterioration in the legal and economic security of French companies in India. The potential additional tax cost was estimated at 10 billion euros for existing contracts alone," said the official.

India and France have reached a decision to delete the MFN clause from their treaty which had historically benefitted only France, according to Indian government documents.

That was to put an end to disagreements related to its interpretation that have led to "tax uncertainty and protracted litigation," said one document.

Switzerland in January also suspended its application of the MFN clause in its India treaty citing the Supreme Court ruling.

(Reporting by Aditya Kalra, Nikunj Ohri and Shivam Patel in New Delhi; Additional reporting by Dominique Patton and Leigh Thomas in France; Editing by Toby Chopra)

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** Lupin LUPN.NS rises 1.38% to 2,062 rupees, highest since May 19

** Pharma co receives Establishment Inspection Report from U.S. FDA for its Aurangabad facility, following product specific pre-approval inspection in September

** Stock rated "buy" on avg; median PT is 2,265 rupees, per data compiled by LSEG

** YTD, LUPN down 12.5%

(Reporting by Mridula Kumar in Bengaluru)

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Nov 12 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - COMMISSIONS DEDICATED ONCOLOGY BLOCK AT VIZAG FACILITY

Source text: ID:nBSE8fCN0k

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

• ANNOUNCES PRESENTATION OF PHASE 1 DATA ON LNP3693 (STING AGONIST)

Source text: ID:nBSEbC38QP

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Oct 11 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN: U.S. FDA HAS CONDUCTED A PRE-APPROVAL INSPECTION AT OUR MANUFACTURING FACILITY LOCATED IN SOMERSET, NEW JERSEY, USA

• LUPIN: THE U.S. FDA INSPECTION WAS CONDUCTED FROM SEPTEMBER 29 TO OCTOBER 10, 2025 AND CONCLUDED WITH ONE OBSERVATION

Further company coverage: LUPN.NS

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** Lupin LUPN.NS rises 3.6% to 1,973.70 rupees; set to snap four-session losing streak

** Pharmaceuticals co plans to build new   manufacturing  facility  in Coral Springs, Florida

** Projected cumulative investment of $250 mln in new facility for R&D, infra and capital expenditures over five years

** New site will have capacity to accommodate production of more than 25 critical respiratory medicines

** Co to get tax credits, incentives from Florida

** Citi says U.S. investment may help co smoothly navigate geopolitical risks like tariffs

** YTD, LUPN falls ~16%

(Reporting by Vijay Malkar)

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** Shares of Lupin LUPN.NS fall 2% to 1,934 rupees

** The pharmaceutical co's Pithampur Unit-2 is classified as OAI (Official Action Indicated) following the US FDA's inspection in July 2025 and received four Form 483 observations

** Classification implies that the site will not receive any new approvals until the observations are addressed- Nomura

** The observations were primarily related to sterile operations at the Pithampur Unit-2, which produces oral solids and ophthalmic products - Nomura

** We think the observations were largely for the ophthalmic product manufacturing - Nomura

** Stock rated "buy" on avg by analysts covering it; median PT is 2243 rupees - as per LSEG data

** Stock down 18% YTD

(Reporting by Komal Salecha)

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Oct 1 (Reuters) - Lupin LUPN.NS:

• LAUNCHES RIVAROXABAN FOR ORAL SUSPENSION IN THE UNITED STATES

Source text: ID:nBSE5SpYZM

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Sept 30 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN LTD - RECEIVES U.S. FDA APPROVAL FOR RIVAROXABAN ORAL SUSPENSION

Source text: ID:nBSE1jRDl1

Further company coverage: LUPN.NS

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** Shares of Lupin LUPN.NS rise 2.2% to 2,031 rupees

** Stock top gainer in Nifty Pharma index.NIPHARM, which is up 0.3%

** Investec upgrades pharma co to "Buy" from "Hold"; raise PT to 2,265 rupees from 2,100, implying 14% upside from last close

** Sees Lupin well-placed to benefit from India's emerging anti-diabetes drug (GLP-1) opportunity, citing its strong positioning in diabetes, cardiac, diagnostics, and consumer segments

** Says consistent execution in complex generics and recent momentum in U.S. business, aided by favorable macro factors

** Highlights niche injectables and potential upside from biosimilars and inhalation products

** LUPN rated "Buy" by 35 analysts on average; median target price is 2,243.5 rupees – data compiled by LSEG

** YTD: LUPN down 13.3% vs Nifty Pharama down 4.8%

(Reporting by Rudra Pratap Singh in Bengaluru)

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

• LUPIN RECEIVES U.S. FDA APPROVAL FOR RISPERIDONE LONG-ACTING INJECTABLE, WITH 180-DAY CGT EXCLUSIVITY, THE FIRST PRODUCT FROM ITS NANOMI'S LONG-ACTING INJECTABLE PLATFORM

Source text: ID:nPre4jhhwa

Further company coverage: LUPN.NS

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** Shares of Lupin Ltd LUPN.NS rise as much as 2.5% to 1,937.4 rupees

** Pharma co gets United States Food and Drug Administration (U.S. FDA) approval for its long-acting injectable drug Risperidone used to treat schizophrenia, bipolar I disorder

** Stock hits highest level in over a week

** Mean rating of stock is 'buy'; their median PT is 2,237 rupees - data compiled by LSEG

** Day's gains trims YTD losses to nearly 20%

(Reporting by Meenakshi Maidas in Bengaluru)

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By Nancy Lapid

Aug 30 (Reuters) - A decades-old pill remains helpful for heart attack patients even with modern treatments that can prevent lasting damage to heart muscle, two large trials have shown.

Still unclear is whether all patients, or only some, benefit from so-called beta-blocker drugs, which are typically prescribed to everyone after a heart attack.

Two sharply contradictory reports were presented on Saturday at a large cardiology meeting in Madrid and published in The New England Journal of Medicine.

“It is not unusual for trials to yield different results,” said Dr. Borja Ibanez of Centro Nacional de Investigaciones Cardiovasculares Carlos III in Madrid, who led one of the trials.

“Somewhat uncommon is to see two trials with apparently divergent findings presented on the same day.”

Most important, Ibanez said, is the finding both teams agree on, which is that beta-blockers reduce the combined risk of another heart attack, heart failure, or death in patients without heart failure but with mildly impaired heart function.

The question is whether the pills are beneficial or useless for those with normally functioning hearts, who account for about 80% of patients after a first heart attack.

Beta-blocker manufacturers include Mylan, Novartis NOVN.S, Pfizer PFE.N, Abbott, Teva Pharmaceutical Industries TEVA.TA, Amneal Pharmaceuticals AMRX.O, Sun Pharmaceutical Industries SUN.NS, Lupin, ANI Pharmaceuticals ANIP.O, and Eagle Pharmaceuticals EGRX.PK.

The drugs work by inhibiting the hormones epinephrine and norepinephrine, thereby lowering heart rate and blood pressure, decreasing the workload on the heart and reducing its oxygen demand.

Both new trials involved heart attack survivors whose hearts were still contracting normally, that is, the left ventricle was pumping out at least 40% of its blood with each beat. Both trials followed patients for roughly 3.5 years.

Among 5,574 volunteers in the BETAMI–DANBLOCK study from Norway and Denmark, the drugs showed a clear benefit. Patients randomly assigned to receive beta-blockers had a 15% lower risk of death or major adverse cardiovascular event, particularly a repeat heart attack, compared to patients not taking these pills, investigators found.

But among the 8,438 participants in the REBOOT trial conducted in Italy and Spain, beta-blockers had no effect on the incidence of death from any cause, a repeat heart attack, or hospitalization for heart failure, according to a separate report.

Some of the difference may be due to the fact that patients didn't all receive the same beta-blockers, and the Scandinavian patients might have been more prone to adverse events because they were slightly older than patients in Spain and Italy and more of them had mild heart dysfunction, said Dr. Dan Atar of the University of Oslo, who led one of the trials.

Among female participants in REBOOT, those taking beta-blockers - particularly those with good heart function receiving higher doses – had more adverse outcomes than women not taking the drugs, researchers reported in the European Heart Journal.

In REBOOT, researchers did see a lower rate of new heart attacks, heart failure, or death with beta-blocker use by patients with mildly reduced heart function, as indicated by a left ventricular “ejection fraction” between 40% and 49%.

The effect in this subgroup was confirmed in an analysis of data pooled from REBOOT, BETAMI–DANBLOCK, and a Japanese trial, according to a report published in The Lancet.

The message for cardiologists, Ibanez said, is “We can now state with confidence that beta-blockers are beneficial” in patients with mildly impaired heart function, and “there remains reasonable uncertainty about their benefit” in patients with normally functioning hearts.

Atar said an analysis looking specifically at beta-blocker use by patients with normal heart function will be presented at a U.S. cardiology meeting in November.

(Reporting by Nancy Lapid; editing by Caroline Humer and Diane Craft)

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Aug 20 (Reuters) - Lupin Ltd LUPN.NS:

• LUPIN - LAUNCHES BOSENTAN TABLETS FOR ORAL SUSPENSION IN UNITED STATES WITH 180-DAY EXCLUSIVITY

Further company coverage: LUPN.NS

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