LUPIN

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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Lupin Ltd LUPN.NS:

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

• LUPIN - RECEIVES TENTATIVE FDA APPROVAL FOR PITOLISANT TABLETS 4.45MG AND 17.8MG

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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

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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)

((UrviManoj.Dugar@thomsonreuters.com; +91 9558725583;))

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 - VISUFARMA B.V. DEAL ANTICIPATED TO COMPLETE IN APRIL 2026

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

• RECEIVES FDA APPROVAL FOR BRIVARACETAM ORAL SOLUTION

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

• SIGNS LICENSE AND SUPPLY AGREEMENT WITH SPEKTUS TO COMMERCIALIZE NOVEL ANTIDEPRESSANT DESLAFLEX IN CANADA

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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)

((Rishika.S@thomsonreuters.com;))

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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Feb 10 (Reuters) - Indian drugmaker Lupin LUPN.NS said on Tuesday it has settled a patent infringement dispute with Japan's Astellas Pharma 4503.T over the bladder disorder drug Mirabegron, allowing it to continue selling the product in the United States.

Under the agreement, Lupin and its U.S. unit will pay Astellas $90 million, including a $75 million upfront payment and per-unit licensing fees on Mirabegron sales through September 2027, the company said in an exchange filing.

The settlement resolves Lupin's pending litigation with Astellas and enables the company to continue marketing Mirabegron in the United States.

Lupin had previously disclosed the patent dispute with the Japanese drugmaker last April over its generic version of Myrbetriq, Astellas' overactive bladder drug.

(Reporting by Surbhi Misra 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.

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

• LAUNCHES DASATINIB TABLETS IN THE UNITED STATES

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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

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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

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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

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

• RECEIVES EIR FROM US FDA FOR NAGPUR FACILITY

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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)

((Email: aditya.kalra@tr.com; X: @adityakalra;))

** 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

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

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

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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

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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)

((Komal@thomsonreuters.com;))

** Shares of Lupin LUPN.NS jump 4% to 1,986.50 rupees, top gainer on pharma index .NIPHARM, which is up 1%

** Co receives U.S. Food and Drug Administration approval for its generic Rivaroxaban for oral suspension

** The drug, which helps treat blood clots and prevent them from coming back in children, will be manufactured at its unit in Maharashtra

** Drug's oral suspension had estimated annual sales of $11 million in the U.S.

** 35 analysts have a "buy" rating on avg; median PT is 2,243 rupees - data compiled by LSEG

** YTD, LUPN down ~16% YTD vs Nifty pharma's 7.4% decline

(Reporting by Urvi Dugar)

((UrviManoj.Dugar@thomsonreuters.com;))

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

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

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