Zydus Lifesciences

June 3 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - RECEIPT OF WARNING LE ER FROM USFDA FOR BADDI FACILITY

• ZYDUS LIFESCIENCES - BELIEVE THAT SAID WARNING LETTER WILL NOT IMPACT CURRENT OPERATIONS, SUPPLIES FROM BADDI SITE

• ZYDUS LIFESCIENCES - TECHNICAL OBSERVATOONS REGARDING THE USE OF PURIFIED TALC

• ZYDUS LIFESCIENCES - PURIFIED TALC THAT DID NOT MEET CURRENT UNITED STATES PHARMACOPEIA REQUIREMENTS

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** Shares of India's Zydus Lifesciences ZYDU.NS jump to 6.15% to 1081.55 rupees

** Co's Q4 consol net profit rose ~8.7% y/y to 12.73 billion rupees ($131.87 million)

** Total revenue from ops rose 16.2%, driven by growth in consumer products, medical technologies segments

** Dolat Capital lifts PT by 96 rupees to 1,182 rupees; raises FY27 and FY28 earnings estimates by 8.6% and 8.9%, respectively, on higher sales, margins

** JPMorgan cuts PT by 10 rupees to 1,050 rupees; raises FY27 earnings estimates by 10% on strong guidance, sees ~15% core EPS CAGR over the next two years

** Jefferies raises FY28 EPS estimates by 14%, citing new product launches

** ZYDU shares closed up 2.8% on Tuesday after results

** YTD, stock up ~11.5%

($1 = 96.5325 Indian rupees)

(Reporting by Bipasha Dey in Bengaluru)

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May 19 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - TO BUYBACK SHARES WORTH UP TO 11 BILLION RUPEES

• ZYDUS LIFESCIENCES - TO BUYBACK SHARES AT 1,150 RUPEES PER SHARE

• ZYDUS LIFESCIENCES - RE-APPOINTS SHARVIL P. PATEL AS MANAGING DIRECTOR FOR 5 YEARS EFFECTIVE APRIL 1, 2027

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** Shares of Zydus Lifesciences ZYDU.NS rise 5% to a more than six-month high at 986 rupees
** The Indian drugmaker to consider equity share buyback proposal on May 19, 2026
** Company's unit buys U.S. specialty drugmaker Assertio for $166.4 million
** Average rating of 27 analysts covering the stock is "hold" and median PT is 975 rupees - data compiled by LSEG
** YTD, ZYDU stock up 7.9%

(Reporting by Brijesh Patel in Bengaluru)

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May 13 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - BOARD TO CONSIDER EQUITY SHARE BUYBACK PROPOSAL ON MAY 19, 2026

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May 6 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - USFDA INSPECTION CONCLUDES AT ZYDUS' BIOLOGICS INJECTABLE PLANT, AHMEDABAD

• ZYDUS LIFESCIENCES - INSPECTION CLOSED WITH SEVEN OBSERVATIONS; NO DATA INTEGRITY RELATED OBSERVATIONS

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May 5 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - UNIT RECEIVES TAX DEMAND AND PENALTY OF 9 MILLION RUPEES EACH

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May 1 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• UNIT BUYS 100% OF APTITUDE ORTHOPEDIE, FRANCE

• ACQUISITION FOR 360,000 EUROS

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April 30 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - SUBSIDIARY HAS BEEN INCORPORATED IN NAME OF ZARA MERGER SUB INC

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April 28 (Reuters) - Algorae Pharmaceuticals Ltd 1AI.AX:

• ALGORAE AND ZYDUS ENTER EXCLUSIVE COMMERCIAL AGREEMENT

• AGREEMENT FOR 10 PRODUCTS WITH ZYDUS LIFESCIENCES FOR AUSTRALIAN AND NEW ZEALAND MARKETS

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April 16 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES- ZYDUS RECEIVES EIR FOR ONCOLOGY INJECTABLE MANUFACTURING FACILITY IN SEZ1, AHMEDABAD

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By Mrinalika Roy and Sriparna Roy

April 9 (Reuters) - A surge in demand since last year for estrogen patches to ease menopause symptoms has strained supplies and led to shortages, sparking a scramble for medicines that industry sources say could last up to three years.

More than 1 million U.S. women begin menopause each year. Over the past two years they have increasingly sought out estrogen patches to treat mood swings, hot flashes and sleep disturbances. Social media in particular has been a forum for changing views on the medicines' safety and benefits.

The U.S. FDA began publicly extolling hormone replacement therapy as "lifesaving" last July, and in November it removed a longstanding safety warning from the therapies. The change in the Food and Drug Administration's stance was followed by a 26% jump in patch use through February, according to data from health data and analytics company Truveta.

"When the FDA removed the safety warning in November, it created unprecedented demand that cannot fully be met at present," said a spokesperson for Swiss generics manufacturer Sandoz SDZ.S, which has shipped additional supplies to the U.S. to help ease shortages.

The patches are a type of hormone replacement therapy that delivers estrogen directly through the skin into the bloodstream.

"For 20 years, less than 5% of women took hormone therapy. Now those numbers are growing... and scaling up production of medications is not as easy as it might seem," said Dr. Gillian Goddard, adjunct assistant professor at the NYU Grossman School of Medicine.

While the FDA has not designated the patches as being in shortage, women are pharmacy-hopping in search of them, reducing or switching dosages and changing brands or types of therapy, according to interviews with six patients, three telehealth companies, and six industry experts.

Abruptly stopping use can restart symptoms, while switching brands may bring new side effects, doctors said.

SEARCHING FOR SUPPLY

Amy Satterlund, 50, a product manager from Fort Pierce, Colorado, has been using the estrogen patch for about 18 months, but has recently struggled to find it.

She said she has had to plan for shortages at CVS pharmacies and long waits at online pharmacy Cost Plus Drugs.

"I do get nervous if I were unable to get my prescription refilled, that side effects or that the symptoms of perimenopause would come back," Satterlund said.

A CVS Health CVS.N spokesperson said manufacturers have been unable to deliver sufficient quantities in recent weeks.

A Cost Plus spokesperson said it has added supply to keep up with exploding demand, but hasn't heard from its suppliers on shortages lasting for an extended period of time.

Andrew Nixon, a spokesman for the U.S. Health and Human Services Department, which oversees the FDA, said the agency is coordinating with companies to support efforts to boost the supply of patches.

CHANGING GUIDANCE, RISING DEMAND

FDA Commissioner Marty Makary last July turned the tables on previous cautions against HRT use. In interviews and postings, he said women had been advised against the treatments due to cancer risks, but that the scientific evidence has changed.

The 2002 Women's Health Initiative study had linked hormone therapy to increased risks for some cancers, dementia, heart attacks and stroke. Now, the American College of Obstetricians and Gynecologists on its website notes risks and benefits to the various types of HRT and advises patients who use them to talk with their doctor every year about whether to continue.

Using its electronic health record database covering more than 130 million patients in all 50 states, Truveta found use of most forms of HRT has climbed in recent years, with the sharpest increase a 184% jump in estrogen patches since 2023. Vaginal cream HRT use rose 122% over the same period.

By February 2026, about 5 out of 100 women aged 45-54 had been prescribed estrogen-based HRT, roughly doubling since 2023, based on an analysis of women who had received any medical prescription during that period.

Telehealth platform HRT Club, which helps patients access hormone therapies and physicians, said patch sales had risen 150% since the FDA's November actions.

MANUFACTURING BARRIERS

Estrogen patches are generic medicines with low profit margins, providing manufacturers few incentives to invest quickly in new production lines or facilities that can take years to build.

Long-term contracts for supplies can also hinder manufacturers from quickly adjusting to demand changes, industry sources and doctors said.

Major makers of the patches, including Amneal AMRX.O, Zydus ZYDU.NS, Sandoz, Noven, and Viatris VTRS.O, all have some doses in shortage, according to the American Society of Health-System Pharmacists.

Amneal and Viatris said they were trying to boost patch supply to meet demand. Zydus and Noven did not respond to a request for comment.

Dr. Mary Rosser, an Ob-Gyn and director of Integrated Women's Health at Columbia University, said the FDA does have ways to mitigate shortages. These could include requiring manufacturers to have more diverse and back-up supply chains, and mandating minimum inventories and proactive inventory monitoring systems, she said.

The FDA declined to comment on such options.

"People have waited a long time to make a decision... about whether they want to use hormones," Rosser said. "Then they make the decision and then they can't get them."

(Reporting by Mrinalika Roy, Mariam Sunny, and Sriparna Roy in Bengaluru; Editing by Caroline Humer and Bill Berkrot)

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April 8 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• RECEIVES FINAL USFDA APPROVAL FOR DAPAGLIFLOZIN TABLETS

Source text: ID:nNSE7lyqfm

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April 6 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - TAX DEMAND OF 41.77 MILLION RUPEES DROPPED

Source text: ID:nNSE7S2XC2

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By Rishika Sadam

HYDERABAD, India, April 3 (Reuters) - Soon-to-be brides and grooms seeking shortcuts to shed pounds before the big day have become the latest consumer target for weight-loss drugs in India.

New Delhi wellness clinic Klarity Skin Clinic touts a "Mounjaro bride" package, while other clinics have woven weight-loss injections into "pre-wedding" transformation packages typically focused on skin treatments and hairstyle makeovers.

In a social media video, Klarity offers "guided nutrition, Mounjaro and smart workouts" to prepare brides to walk down the aisle. The clinic did not respond to a request for comment.

Eight doctors interviewed by Reuters said they have been fielding inquiries from brides, and some grooms, about taking weight-loss drugs before taking their vows. Many asked for Eli Lilly's LLY.N Mounjaro, the first GLP-1 medication to enter India's market for both diabetes and weight loss. It has become more sought after than Novo Nordisk's NOVOb.CO rival Wegovy, the doctors said.

"Over the last few months, over 20% of the queries we've received for obesity injections are from to-be brides, who also openly give us a timeline on how soon they are getting married," said Rajat Goel, a bariatric surgeon at Hindivine Healthcare in New Delhi.

He said he prescribed the drugs only if patients were medically eligible, not for cosmetic use.

TRADITION AND SOCIETAL PRESSURE

Weddings in India are grand affairs for families that can afford them, with culture and tradition exerting a strong influence. Many marriages continue to be arranged by families, often bringing expectations around physical appearance and financial status.

Aditi, a 26-year-old finance worker from Mumbai, consulted a doctor in November for a weight-loss prescription after exercise and diet failed to get the desired results.

"When I see the result, I feel happy,” Aditi said about losing 10 kilograms (22 pounds) on Mounjaro before her February wedding. "If I am not happy, I don't feel confident. I did not want to feel that way at the time of the wedding."

She is one of the half a dozen brides, and one groom, who spoke to Reuters about pre-wedding use of weight-loss drugs, but asked not to use their family names due to social stigmas. They cited societal pressure to look a "certain way" at their wedding and most had discontinued the injections soon after.

Novo and Lilly launched their obesity drugs in India last year. The market is forecast to reach 80 billion rupees ($851.79 million) by 2030. Mounjaro sales doubled in the months after launch, making it the highest-selling drug in the world's most populous nation.

Indian drugmakers began selling cheaper versions of Novo's medicine last month after the patent on semaglutide, its active ingredient, expired, widening access.

The drugs are intended for adults classified as obese, or for those considered overweight with a weight-related medical condition such as diabetes, hypertension or sleep apnea.

"Mounjaro has been approved by regulators for specific medical indications and is intended to be used only under the supervision of a qualified healthcare professional," Lilly said in a statement.

The lowest Mounjaro injection pen dose sells for 13,125 rupees ($139.50) per month in India, while the highest dose costs 25,781 rupees.

Novo, which this week cut prices of Ozempic and Wegovy for the second time, is selling the lowest Wegovy dose for 5,660 rupees ($60.90) and the highest for 16,400 rupees a month.

Novo said it discourages any form of self-medication of semaglutide or deviation from the indicated use on label.

CHEAPER DRUGS, MISUSE CONCERNS

India could have more than 440 million overweight or obese people by 2050, one of the world's highest totals, according to The Lancet.

Akshitha, who got married in Hyderabad last year, said the drugs helped her shed 15 kg (33 pounds), taking her weight to 76 kg before the wedding. A family doctor had suggested she try the injections when she worried about her weight, she said.

"There's so much chaos before the wedding, with all the planning and preparation. I knew I would not get time to go to the gym and be on a diet. That's when these drugs looked like a better option," she said, adding she might consider using them again after a future pregnancy.

With local drugmakers flooding the market with cheaper weight-loss medicines, India's drugs regulator has raised concerns about misuse and intensified scrutiny of unauthorized sales and promotion.

"We understand the curiosity, but this cannot be a quick fix," said Dr. Swati Pradhan, founder of obesity and metabolic wellness clinic Live Light.

Pradhan said she prescribed the injections to only a few soon-to-be brides if they were medically eligible and showed signs of other medical issues, while insisting on lifestyle changes for sustainable results.

For 27-year-old Priya, a tech worker from Bengaluru, weight-loss drugs became a way to counter body-shaming from prospective grooms' families.

"I've had men and their families reject my proposal because of my weight. I was told I was fat," Priya told Reuters.

She initially used Novo's oral semaglutide, approved in India for diabetes, as an off-label treatment and lost more than 12 kg before switching to injectable Mounjaro.

Her search for a groom continues.

($1 = 94.0850 Indian rupees)

(Reporting by Rishika Sadam in Hyderabad; Editing by Bill Berkrot)

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April 1 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• RECEIVES DEMAND ORDER FOR FY2019-20 TO FY2023-24

• GETS TAX DEMAND ORDER WORTH 14.2 MILLION RUPEES

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Adds details, background, comments

By Rishika Sadam

March 31 (Reuters) - Novo Nordisk NOVOb.CO has again cut the prices of its blockbuster diabetes and weight-loss drugs Ozempic and Wegovy by up to 36% and 48% in India, to fend off competition from cheaper generics made by local drugmakers.

India's market for diabetes and weight-loss drugs is set for a shake-up after the Danish drugmaker's patent on semaglutide, the active component in Ozempic and Wegovy, expired on March 20.

At least half a dozen Indian drugmakers, including Dr Reddy's REDY.NS, Zydus ZYDU.NS and Sun Pharma SUN.NS, launched multiple brands of the blockbuster diabetes and weight-loss drugs, up to 70% cheaper than Novo's drugs in some cases.

Ozempic's and Wegovy's lowest doses of 0.25 mg in India will now be priced at 1,415 rupees ($15.04) for a weekly shot from 2,200 rupees and 2,712 rupees earlier, respectively, Novo Nordisk India said in a statement on Tuesday.

The average price reduction across doses is 23.8% for Ozempic and 27% for Wegovy, it said.

"We've heard from patients and doctors, and we're acting on that feedback," said Vikrant Shrotriya, managing director at Novo Nordisk India, adding that the drugs also offer cardiovascular benefits.

The entry of generics will also challenge Novo and U.S. rival Eli Lilly LLY.N, which launched its blockbuster diabetes and obesity drugs in India last year, as they seek to cement their position in the country.

Lilly's Mounjaro became India's top-selling drug by value within months of its launch, according to data from Pharmarack, a research firm.

Novo's Ozempic is available in three dose strengths of 0.25 mg, 0.5 mg and 1 mg in India, while Wegovy has five dose strengths.

Ozempic's and Wegovy's 1 mg weekly shot is now priced at 2,275 rupees ($24.18) after price cuts of 18.5% and 34.2%, respectively. The company slashed Wegovy's 0.5 mg dose price by 41.5% to 2,025 rupees.

"..this price reduction reflects how innovation can become more accessible when market dynamics evolve," Venu Gopal Pareek, a bariatric surgeon said, adding that patients might choose Novo's drugs over generics given that it is an original molecule, and if the price difference is not beyond 15%.

Last year, Novo slashed Wegovy's price for the first time by up to 37% from its launch price, anticipating stiff competition from local drugmakers.

($1 = 93.9890 Indian rupees)

(Reporting by Rishika Sadam and Yagnoseni Das in Bengaluru; Editing by Devika Syamnath and Janane Venkatraman)

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March 25 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• RECEIVES TAX DEMAND PENALTY OF 32.8 MILLION RUPEES

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Adds background, details from statement

March 24 (Reuters) - India's drug regulator has tightened surveillance against the unauthorised sale and promotion of weight-loss drugs, the health ministry said on Tuesday, after local drugmakers launched cheaper generic versions of Ozempic and Wegovy over the weekend.

At least half a dozen Indian drugmakers, including Dr Reddy's REDY.NS, Zydus ZYDU.NS and Sun Pharma SUN.NS, launched multiple brands of the blockbuster diabetes and weight-loss drugs, up to 70% cheaper than Novo Nordisk's drugs in some cases, after the patent for semaglutide expired last week.

Semaglutide is the active component in Ozempic and Wegovy.

The patent expiry had triggered concerns about misuse and confusion among prescribers as costs fall sharply.

The Central Drugs Standard Control Organization (CDSCO) conducted inspections at 49 entities across the country, including drug wholesalers, retailers, and slimming clinics, the statement said.

It focused on identifying violations related to unauthorised sale, improper prescription practices, and misleading marketing, the statement said, adding that notices were sent to defaulting entities.

"These drugs, when used without proper medical supervision, may lead to serious adverse effects and related health risks," the statement said, adding that there have been concerns regarding their on-demand availability across various platforms.

Earlier this month, the CDSCO also warned pharmaceutical companies against direct or indirect advertising of weight-loss medicines, including obesity awareness campaigns that could act as surrogate promotions.

Analysts had expected more than 40 Indian drugmakers to launch over 50 brands after patent expiry, as they race to grab a share of the market that could grow to 80 billion rupees ($852.62 million) by 2030 from about 15 billion rupees today, according to research firm Pharmarack.

($1 = 93.8280 Indian rupees)

(Reporting by Rishika Sadam in Hyderabad and Urvi Dugar in Bengaluru; Editing by Rashmi Aich and Janane Venkatraman)

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March 20 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - LAUNCHES SEMAGLUTIDE INJECTION IN REUSABLE MULTI-DOSE PEN DEVICE IN INDIA

• ZYDUS LIFESCIENCES - HAS EXCLUSIVE RIGHTS TO REUSABLE PEN DEVICE FOR SEMAGLUTIDE

• ZYDUS LIFESCIENCES - SEMAGLUTIDE INJECTION PRICED AT 2,200 RUPEES PER MONTH

• ZYDUS LIFESCIENCES - ZYDUS' SEMAGLUTIDE INJECTION WILL BE AVAILABLE IN 15MG/3ML CARTRIDGE

• ZYDUS LIFESCIENCES - SEMAGLUTIDE LAUNCHED UNDER SEMAGLYN, MASHEMA, AND ALTERME BRANDS

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March 19 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LAUNCHES AEROLIFE MINI, TO SIMPLIFY INHALER USE FOR ASTHMA AND COPD PATIENT

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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 16 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - SENTYNL THERAPEUTICS ENTERS INTO AGREEMENT WITH PRG S&T

• ZYDUS LIFESCIENCES - AGREEMENT TO LICENSE MOLECULE FOR HUTCHINSONGILFORD PROGERIA SYNDROME

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March 13 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• RECEIVES FINAL APPROVAL FROM USFDA FOR CEVIMELINE HYDROCHLORIDE CAPSULES 30MG

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Feb 27 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - SUCCESSFUL CLINICAL DEVELOPMENT OF PEMBROLIZUMAB BIOSIMILAR FYB206

• ZYDUS LIFESCIENCES - ACHIEVEMENT CLEARS PATHWAY FOR NEAR-TERM BLA FILING WITH USFDA

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Feb 25 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS PLANS TO LAUNCH INNOVATIVE SEMAGLUTIDE INJECTION IN INDIA ON DAY 1 OF PATENT EXPIRY

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Feb 19 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• LAUNCHES BIOSIMILAR AFLIBERCEPT 2 MG ANYRA

• SIGNS AGREEMENT WITH REGENERON AND BAYER

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Feb 18 (Reuters) - Zydus Lifesciences Ltd ZYDU.NS:

• ZYDUS LIFESCIENCES - RECEIVES USFDA APPROVAL FOR BOSENTAN TABLETS, 32 MG

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