Dr. Reddy's Labs.

Adds details paragraph 2 onwards

Sept 18 (Reuters) - Dr Reddy's Laboratories REDY.NS said on Friday it had signed an agreement with Japanese drugmaker Takeda Pharmaceutical 4502.T to promote and distribute the Qdenga dengue vaccine in India.

The deal comes months after India's drug regulator approved Qdenga for use in both children and adults, making it the first dengue vaccine cleared for the country.

Dr Reddy's said the vaccine is expected to be available in India in the first half of 2027.

Dengue, a mosquito-borne viral infection, is among the world's fastest-growing vector-borne diseases. The World Health Organization reported a record 14.4 million dengue cases and 11,201 deaths globally in 2024, including 232,425 cases and 233 deaths in India.

Qdenga is administered in two 0.5 ml doses, given three months apart, and can be used irrespective of prior dengue infection, removing the need for pre-vaccination screening.

(Reporting by Kashish Tandon in Bengaluru; Editing by Sonia Cheema)

(([email protected]; 8800437922;))

Aug 14 (Reuters) - Dr Reddy's Laboratories Ltd REDY.NS:

• DR REDDY'S - USFDA INSPECTION AT API FACILITY IN UK CLASSIFIED 'VOLUNTARY ACTION INDICATED' AND OFFICIALLY CLOSED

Source text: ID:nBSE9nR5Rf

Further company coverage: REDY.NS

(([email protected];))

Dr. Reddy’s Laboratories’ CEO for API and Services, Deepak Sapra, resigned to pursue opportunities outside the company and was due to leave on November 12, 2026. Sapra had spent more than 23 years with the pharmaceutical maker, joining in 2003 and working across roles, responsibilities and geographies. Global generics accounted for roughly 89% of Dr. Reddy’s revenue in the June 2026 quarter, with PSAI contributing 11%. The company had consolidated revenue of about ₹33,600 crore in FY26 and net cash of ₹3,060 crore.

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Updates data on Biogen manufacturing plants in paragraph 18

Aug 11 (Reuters) - Global drugmakers are expanding their U.S. footprint, pledging billions of dollars to ramp up manufacturing capacity and research in the country.

Pharmaceutical companies including Eli Lilly, Pfizer, AstraZeneca and Roche have announced roughly $500 billion in U.S. investments as they seek to strengthen infrastructure, mitigate supply-chain risks and reassure investors.

Pfizer PFE.N

Pfizer reached a deal with President Donald Trump on September 30 to invest $70 billion in research and development and domestic manufacturing, and received a three-year grace period exempting its products from the pharmaceutical-targeted tariffs.

GSK GSK.L

The London-based drugmaker plans to invest $30 billion in U.S. research and development and supply chain infrastructure over five years.

Eli Lilly LLY.N

U.S. President Donald Trump said in January that Eli Lilly plans to build six plants in the United States.

Lilly said last year that it planned to spend at least $27 billion to build four U.S. plants to expand production and bolster medical supply chains. The company has since announced details on three plants, in Alabama, Virginia and Texas.

Lilly in January said it will build a $3.5 billion pharmaceutical manufacturing facility in Pennsylvania, its fourth new site, in an effort to expand U.S. production and bolster medical supply chains.

Johnson & Johnson JNJ.N

The drugmaker plans to raise U.S. investments by 25%, totaling $55 billion, over the next four years. It plans to build four plants, including one in Wilson, North Carolina, and another at Tokyo-based Fujifilm Biotechnologies' manufacturing site in Holly Springs, North Carolina, over the next 10 years.

The company said in June it has invested about $1 billion in Jacksonville, Florida, to strengthen U.S.-based manufacturing for its eye care business. The new facility is expected to be fully operational in 2028, J&J said.

Roche ROG.S

The Swiss drugmaker said in April last year it would invest $50 billion in the U.S. over the next five years.

A month later, it announced an additional $550 million investment to expand its Indianapolis diagnostics manufacturing hub. The expansion will span Indiana, Pennsylvania, Massachusetts, and California, creating more than 12,000 jobs.

In January, Roche said it will more than double its investment in its drug manufacturing facility in Holly Springs, North Carolina, to about $2 billion, up from the over $700 million announced in May 2025.

AstraZeneca AZN.L

The Anglo-Swedish drugmaker will invest $50 billion in U.S. manufacturing by 2030. The investment will fund a new drug substance facility in Virginia, its largest single-site global investment, alongside expansions in Maryland, Massachusetts, California, Indiana and Texas.

It has already started technology transfers and is managing inventory in 2025 to minimize any tariff hit. Company executives have said the impact would be "very short-lived."

Novartis NOVN.S

The Swiss drugmaker plans to spend $23 billion to build and expand 10 facilities in the U.S. over the next five years. This includes building six new manufacturing plants and expanding its San Diego research and development site, which is expected to create more than 1,000 jobs.

Sanofi SASY.PA

The French drugmaker plans to invest at least $20 billion in the U.S. through 2030 to boost manufacturing and research. Sanofi plans to expand its U.S. manufacturing capacity through direct investments in the company's sites and partnerships with other domestic manufacturers.

Chief Financial Officer François Roger said in July the potential tariffs are expected to have a limited impact in 2025, as the company already has inventory in place in the U.S.

Biogen BIIB.O

The U.S. drugmaker will invest $2 billion more in its existing manufacturing plants in North Carolina, adding capacity for gene-targeting therapies and automation. The company has eight factories in the state.

Merck MRK.N

The U.S. drugmaker has begun building a $3 billion pharmaceutical manufacturing plant in Virginia as part of its over $70 billion investment to expand domestic manufacturing and research and development.

It will also invest $1 billion in a new Delaware plant to make biologics and cancer drug Keytruda, to boost U.S. production and potentially create over 4,500 jobs. It also opened a $1 billion facility at its North Carolina site in March.

Merck's animal health unit will invest $895 million to expand its Kansas manufacturing and R&D site, part of a broader $9 billion U.S. investment through 2028.

CEO Robert Davis in July flagged minimal impact from potential tariffs in 2025, and that the company remained well-positioned due to inventory management and moving of manufacturing to the U.S.

Amgen AMGN.O

The U.S.-based biopharma firm plans to invest $900 million to expand its Ohio manufacturing facility, bringing total investment in the state to $1.4 billion and adding 750 jobs. In December, the company committed $1 billion to build a second facility in Holly Springs, North Carolina.

Amgen said in September it is investing more than $600 million to build a new research and development center at its headquarters in Thousand Oaks, California.

The drugmaker announced it will invest $650 million to expand drug manufacturing at its facility in Juncos, Puerto Rico, a move expected to create nearly 750 jobs.

Amgen said it would invest an additional $300 million in its U.S. manufacturing network, expanding its biologics facility in Puerto Rico and supporting hundreds of construction jobs.

Novo Nordisk NOVOb.CO

The Danish pharmaceutical company said in August its strong U.S. manufacturing footprint positions it well for tariff challenges, describing itself as "very U.S.-centric and U.S.-focused".

AbbVie ABBV.N

The U.S. drugmaker said in January it has committed $100 billion over the next decade to U.S.-based research and development as part of its three-year deal with the Trump administration to reduce drug prices.

It has 11 manufacturing sites in the U.S. and has said it is "fairly insulated" from any tariff impact this year, given inventory management actions.

The company said in February that it plans to invest $380 million to build two manufacturing facilities at its current North Chicago, Illinois, campus, to support the production of its neuroscience and obesity medications.

Gilead Sciences GILD.O

Earlier this year, the drugmaker announced $11 billion in new planned investment in the U.S. to add to its domestic manufacturing and research heft, taking its total pledged investment to $32 billion.

Gilead said in September that it started work on a pharmaceutical development and manufacturing hub at its headquarters in Foster City, California, in addition to which, it is currently developing two other sites.

Bristol Myers Squibb BMY.N

The drugmaker said it would invest about $2.3 billion to build a new drug manufacturing facility in Houston, Texas, creating nearly 500 skilled jobs and about 2,000 construction-related jobs, as part of its broader $40 billion U.S. investment commitment.

Cipla CIPL.NS

The Indian drugmaker is expanding its U.S. manufacturing footprint by investing in capacity expansion for complex respiratory products at its advanced facilities in Fall River, Massachusetts, and Central Islip, New York.

CSL CSL.AX

Australia's CSL said in November it would invest $1.5 billion in the U.S. to manufacture plasma-derived therapies, expanding its footprint in the country over the next five years.

In March, the company announced the expansion of its plasma therapy manufacturing facility in Kankakee, Illinois, which is expected to be operational by 2031.

(Reporting by Siddhi Mahatole, Kamal Choudhury, Puyaan Singh, Sneha S K, Sahil Pandey and Mariam Sunny in Bengaluru; Editing by Tasim Zahid, Sahal Muhammed, Shinjini Ganguli and Maju Samuel)

(([email protected];))

Changes dateline, adds Bristol Myers investment plan

Aug 10 (Reuters) - Global drugmakers are expanding their U.S. footprint, pledging billions of dollars to ramp up manufacturing capacity and research in the country.

Pharmaceutical companies including Eli Lilly, Pfizer, AstraZeneca and Roche have announced roughly $500 billion in U.S. investments as they seek to strengthen infrastructure, mitigate supply-chain risks and reassure investors.

Pfizer PFE.N

Pfizer reached a deal with President Donald Trump on September 30 to invest $70 billion in research and development and domestic manufacturing, and received a three-year grace period exempting its products from the pharmaceutical-targeted tariffs.

GSK GSK.L

The London-based drugmaker plans to invest $30 billion in U.S. research and development and supply chain infrastructure over five years.

Eli Lilly LLY.N

U.S. President Donald Trump said in January that Eli Lilly plans to build six plants in the United States.

Lilly said last year that it planned to spend at least $27 billion to build four U.S. plants to expand production and bolster medical supply chains. The company has since announced details on three plants, in Alabama, Virginia and Texas.

Lilly in January said it will build a $3.5 billion pharmaceutical manufacturing facility in Pennsylvania, its fourth new site, in an effort to expand U.S. production and bolster medical supply chains.

Johnson & Johnson JNJ.N

The drugmaker plans to raise U.S. investments by 25%, totaling $55 billion, over the next four years. It plans to build four plants, including one in Wilson, North Carolina, and another at Tokyo-based Fujifilm Biotechnologies' manufacturing site in Holly Springs, North Carolina, over the next 10 years.

The company said in June it has invested about $1 billion in Jacksonville, Florida, to strengthen U.S.-based manufacturing for its eye care business. The new facility is expected to be fully operational in 2028, J&J said.

Roche ROG.S

The Swiss drugmaker said in April last year it would invest $50 billion in the U.S. over the next five years.

A month later, it announced an additional $550 million investment to expand its Indianapolis diagnostics manufacturing hub. The expansion will span Indiana, Pennsylvania, Massachusetts, and California, creating more than 12,000 jobs.

In January, Roche said it will more than double its investment in its drug manufacturing facility in Holly Springs, North Carolina, to about $2 billion, up from the over $700 million announced in May 2025.

AstraZeneca AZN.L

The Anglo-Swedish drugmaker will invest $50 billion in U.S. manufacturing by 2030. The investment will fund a new drug substance facility in Virginia, its largest single-site global investment, alongside expansions in Maryland, Massachusetts, California, Indiana and Texas.

It has already started technology transfers and is managing inventory in 2025 to minimize any tariff hit. Company executives have said the impact would be "very short-lived."

Novartis NOVN.S

The Swiss drugmaker plans to spend $23 billion to build and expand 10 facilities in the U.S. over the next five years. This includes building six new manufacturing plants and expanding its San Diego research and development site, which is expected to create more than 1,000 jobs.

Sanofi SASY.PA

The French drugmaker plans to invest at least $20 billion in the U.S. through 2030 to boost manufacturing and research. Sanofi plans to expand its U.S. manufacturing capacity through direct investments in the company's sites and partnerships with other domestic manufacturers.

Chief Financial Officer François Roger said in July the potential tariffs are expected to have a limited impact in 2025, as the company already has inventory in place in the U.S.

Biogen BIIB.O

The U.S. drugmaker will invest $2 billion more in its existing manufacturing plants in North Carolina, adding capacity for gene-targeting therapies and automation. The company has seven factories in the state, with an eighth set to begin operations in late 2025.

Merck MRK.N

The U.S. drugmaker has begun building a $3 billion pharmaceutical manufacturing plant in Virginia as part of its over $70 billion investment to expand domestic manufacturing and research and development.

It will also invest $1 billion in a new Delaware plant to make biologics and cancer drug Keytruda, to boost U.S. production and potentially create over 4,500 jobs. It also opened a $1 billion facility at its North Carolina site in March.

Merck's animal health unit will invest $895 million to expand its Kansas manufacturing and R&D site, part of a broader $9 billion U.S. investment through 2028.

CEO Robert Davis in July flagged minimal impact from potential tariffs in 2025, and that the company remained well-positioned due to inventory management and moving of manufacturing to the U.S.

Amgen AMGN.O

The U.S.-based biopharma firm plans to invest $900 million to expand its Ohio manufacturing facility, bringing total investment in the state to $1.4 billion and adding 750 jobs. In December, the company committed $1 billion to build a second facility in Holly Springs, North Carolina.

Amgen said in September it is investing more than $600 million to build a new research and development center at its headquarters in Thousand Oaks, California.

The drugmaker announced it will invest $650 million to expand drug manufacturing at its facility in Juncos, Puerto Rico, a move expected to create nearly 750 jobs.

Amgen said it would invest an additional $300 million in its U.S. manufacturing network, expanding its biologics facility in Puerto Rico and supporting hundreds of construction jobs.

Novo Nordisk NOVOb.CO

The Danish pharmaceutical company said in August its strong U.S. manufacturing footprint positions it well for tariff challenges, describing itself as "very U.S.-centric and U.S.-focused".

AbbVie ABBV.N

The U.S. drugmaker said in January it has committed $100 billion over the next decade to U.S.-based research and development as part of its three-year deal with the Trump administration to reduce drug prices.

It has 11 manufacturing sites in the U.S. and has said it is "fairly insulated" from any tariff impact this year, given inventory management actions.

The company said in February that it plans to invest $380 million to build two manufacturing facilities at its current North Chicago, Illinois, campus, to support the production of its neuroscience and obesity medications.

Gilead Sciences GILD.O

Earlier this year, the drugmaker announced $11 billion in new planned investment in the U.S. to add to its domestic manufacturing and research heft, taking its total pledged investment to $32 billion.

Gilead said in September that it started work on a pharmaceutical development and manufacturing hub at its headquarters in Foster City, California, in addition to which, it is currently developing two other sites.

Bristol Myers Squibb BMY.N

The drugmaker said it would invest about $2.3 billion to build a new drug manufacturing facility in Houston, Texas, creating nearly 500 skilled jobs and about 2,000 construction-related jobs, as part of its broader $40 billion U.S. investment commitment.

Cipla CIPL.NS

The Indian drugmaker is expanding its U.S. manufacturing footprint by investing in capacity expansion for complex respiratory products at its advanced facilities in Fall River, Massachusetts, and Central Islip, New York.

CSL CSL.AX

Australia's CSL said in November it would invest $1.5 billion in the U.S. to manufacture plasma-derived therapies, expanding its footprint in the country over the next five years.

In March, the company announced the expansion of its plasma therapy manufacturing facility in Kankakee, Illinois, which is expected to be operational by 2031.

(Reporting by Siddhi Mahatole, Kamal Choudhury, Puyaan Singh, Sneha S K, Sahil Pandey and Mariam Sunny in Bengaluru; Editing by Tasim Zahid, Sahal Muhammed, Shinjini Ganguli and Maju Samuel)

(([email protected];))

Aug 7 (Reuters) - Novartis India Ltd NOIN.BO:

• NOVARTIS INDIA - APPROVES TERMINATION OF DISTRIBUTION AGREEMENT WITH DR. REDDY’S LABORATORIES

• NOVARTIS INDIA - TERMINATION AGREEMENT WITH DR. REDDY’S EFFECTIVE SEPTEMBER 30, 2026

• NOVARTIS INDIA - TO RE-BUY EXCLUSIVITY AND MARKET ACCESS FOR PRODUCTS AFTER DRL AGREEMENT TERMINATION

Source text: ID:nBSE9P3wlf

Further company coverage: NOIN.BO

(([email protected];;))

Dr. Reddy's Laboratories received US FDA approval for its rituximab biosimilar, a biosimilar to Rituxan, for the American market. Fresenius Kabi holds exclusive rights to commercialise the product in the United States under a partnership agreement. The approval followed a recent pre-license inspection at the company's biologics manufacturing facility in Bachupally, Hyderabad, and landed on the FDA's goal date. The product was already commercialised in India, the European Union, the United Kingdom and more than 25 emerging markets, and had received marketing approval in Switzerland and Canada. Dr. Reddy's launched the rituximab biosimilar in Europe in 2025 as part of its expanding global biosimilars portfolio, which also includes bevacizumab and pegfilgrastim.

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Aug 1 (Reuters) - Dr Reddy's Laboratories Ltd REDY.NS:

• DR REDDY'S - RECEIVES U.S. FDA APPROVAL FOR RITUXIMAB BIOSIMILAR

Source text: ID:nBSE6lpY3R

Further company coverage: REDY.NS

(([email protected];))

July 27 (Reuters) - Dr Reddy's Laboratories Ltd REDY.NS:

• DR REDDY'S SAYS THAI FDA APPROVES NUZOLVENCE (ZOLIFLODACIN) - STATEMENT

Further company coverage: REDY.NS

(([email protected];))

Dr. Reddy's Laboratories reported consolidated revenue of ₹80.7 billion for the quarter ended June 2026, a decline of 6% year-on-year, impacted by a sharp drop in lenalidomide sales and a ₹2.4 billion provision for out-of-specification semaglutide batches. Gross margin contracted to 46.5% from 56.9% a year earlier. In a separate development, the company disclosed that the US FDA conducted a pre-license inspection of its biologics manufacturing site in Bachupally, Hyderabad, in June, and issued a Form 483 with seven observations. The company stated it had responded within the stipulated timeline. It also named Dr. Sridevi Khambhampaty as Global Head of Biologics and appointed Deloitte Haskins & Sells as its independent registered public accounting firm for US filings.

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Dr. Reddy's Laboratories reported its Q1 FY27 results on July 22, posting a 71% year-on-year decline in profit before tax to ₹5.5 billion, weighed down by a ₹2.4 billion provision related to out-of-specification semaglutide batches. The board also approved the appointment of Dr. Sridevi Khambhampaty as Global Head of Biologics. Separately, the earnings release disclosed that the company's biologics facility in Bachupally, Hyderabad, received a Form 483 with seven observations from the US FDA following a pre-license inspection in June. The company stated that responses were provided within the stipulated timeline. Deloitte Haskins & Sells was also appointed as the independent registered public accounting firm for US SEC filings.

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Rewrites, adds exec comments from call, analyst comment

By Rishika Sadam

HYDERABAD, July 22 (Reuters) - Indian drugmaker Dr Reddy's Laboratories REDY.NS missed quarterly profit estimates and warned that semaglutide supply disruptions could weigh on availability in global markets as it pursues regulatory approvals in Brazil, Turkey and Mexico.

The company, which sees semaglutide as a key growth driver in India and select overseas markets, said earlier in July its generic version would remain unavailable in India and disrupted in Canada until at least late October.

An impurity issue in the active ingredient forced it to halt production of new batches in the only two countries where it has secured approval so far.

The setback prompted Dr Reddy's to cut its fiscal-year semaglutide sales target to 6 million to 7 million pens from 12 million pens estimated earlier. The active ingredient in Danish drugmaker Novo Nordisk's NOVOb.CO blockbuster weight-loss drug Wegovy is off patent in India, opening the market to generic drugmakers.

CEO Erez Israeli said the disruption would not affect planned regulatory filings in overseas markets but would delay production scale-up by three to four months despite strong demand.

"When we come back, we will need to allocate the output that we can," he said in a post-earnings call. "It may affect other markets in that respect."

Dr Reddy's booked a one-time provision of 2.39 billion rupees ($24.75 million) for inventory and other costs linked to the disruption during the first quarter.

"The bigger near-term earnings impact is likely to come from lost semaglutide sales and fixed commercial costs during the supply interruption," Nirmal Bang analyst Niharika Agarwal said. The company sold only 180,000 pens before halting supplies, she added.

Revenue from operations fell 5.5% to 81 billion rupees, missing analysts' estimate of 81.6 billion rupees, as North America sales slumped 35.3% amid pricing pressure and intensifying competition.

U.S. TARIFF UNCERTAINTY

Adding to concerns over its largest market, U.S. President Donald Trump on Tuesday outlined a phased tariff plan for imported generic medicines, giving drugmakers a two-year window before duties take effect.

"It is not practical to move operations like that to the United States. And obviously, if tariffs are imposed, we'll have to raise prices," Israeli said, adding that the company would monitor developments.

Dr Reddy's would consider investing in the United States, but not in response to tariff pressure, the CEO added.

Consolidated net profit fell 68.7% to 4.44 billion rupees ($45.98 million) in the quarter ended June 30, missing analysts' estimate of 7.22 billion rupees, according to LSEG data.

Revenue from India rose 16.8% to 17.2 billion rupees. The company expects domestic semaglutide sales to expand broadly in line with the market's double-digit growth trajectory.

($1 = 96.5650 Indian rupees)

(Reporting by Rishika Sadam and Kashish Tandon; Editing by Eileen Soreng, Dhanya Skariachan and Joyjeet Das)

(([email protected];))

Adds details, context and background from paragraphs 2 onwards

By Nqobile Dludla

JOHANNESBURG, July 20 (Reuters) - South Africa's Aspen Pharmacare APNJ.J said on Monday that its Canadian subsidiary had received regulatory approval from Health Canada for Aspen-Semaglutide, a generic version of Novo Nordisk's NOVOb.CO blockbuster diabetes drug Ozempic.

Africa's biggest pharmaceutical company said in a statement that its generic semaglutide is authorized for the management of type 2 diabetes.

The expiry of Novo's patent for semaglutide, the active ingredient in the Danish drugmaker's blockbuster GLP-1 drugs Ozempic for diabetes and Wegovy for weight loss, has opened the door for several drugmakers looking to enter the Canadian market with generic versions, which are essentially copies of branded drugs.

The timing of Aspen's commercial launch in Canada remains dependent on the availability of semaglutide active pharmaceutical ingredient (API) supply from India's Dr. Reddy's Laboratories REDY.NS, the company said.

An API is the key compound in a drug that produces its therapeutic effect.

Earlier this month, Dr Reddy's said that supplies of its generic semaglutide would remain unavailable in India and face disruptions in Canada until at least late October after an impurity issue in the drug's active ingredient halted production of new batches.

In March, Aspen's CEO Stephen Saad said Aspen's generics will be manufactured at its South African and French facilities, with the bigger volumes via multi-dose pens set to be produced at the South African facility.

The French facility will produce single-dose autoinjector medicine.

(Reporting by Nqobile Dludla;
Editing by Alison Williams and Susan Fenton)

(([email protected]; +27103461066;))

July 17 (Reuters) - Danish drugmaker Novo Nordisk NOVOb.CO said on Friday that India's drug regulator has approved its obesity drug Wegovy for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), a serious form of fatty liver disease.

Here are a few details:

• The Central Drugs Standard Control Organisation approved Wegovy's 2.4 mg semaglutide injection for the treatment of MASH, Novo Nordisk said.

• MASH is caused by a buildup of fat in the liver that can lead to inflammation and liver damage. The condition is part of a broader spectrum of fatty liver disease and can progress to more severe liver complications if left untreated.

• Novo Nordisk said about two in three people in India have fatty liver disease, highlighting the country's large potential patient population.

• It is a silent disease, and people often do not have symptoms until the disease has progressed to an advanced stage, the company added.

• Wegovy, Novo Nordisk's blockbuster obesity medicine, contains the active ingredient semaglutide and is already approved in multiple markets, including India, for chronic weight management.

• Novo has been vying for a share of India's fast-growing obesity-drug market against Eli Lilly's LLY.N Mounjaro and lower-cost generic semaglutide products launched by local drugmakers such as Dr Reddy's REDY.NS and Sun Pharma SUN.NS.

• The company sold about 76,000 units of Wegovy in India in the first six months of 2026, according to data from market researcher Pharmarack.

(Reporting by Rishika Sadam in Hyderabad; Editing by Sherry Jacob-Phillips)

(([email protected];))

July 10 (Reuters) - Shares of Dr Reddy's Laboratories REDY.NS slipped 3% on Friday, extending losses from the previous session, after a disruption in the supply of its generic semaglutide fuelled fears of delayed commercialisation and prompted analysts to flag earnings risks and a potential loss of first-mover advantage.

The stock was trading at 1,230 rupees, and was the top loser on the pharma index .NIPHARM which was down 0.6%.

(Reporting by Kashish Tandon in Bengaluru)

(([email protected]; 8800437922;))

Corrects headline and text to say Dr Reddy's will delay semaglutide supply, not production

July 9 (Reuters) - Indian drugmaker Dr Reddy's Laboratories REDY.NS said on Thursday that commercial supplies of semaglutide have been delayed due to an active ingredient-related issue in certain batches.

(Reporting by Kashish Tandon in Bengaluru; Editing by Sherry Jacob-Phillips)

(([email protected]; 8800437922;))

Dr. Reddy's Laboratories said the USFDA completed a pre-license inspection of its biologics manufacturing facility in Bachupally, Hyderabad, on June 25, 2026. The inspection, which ran from June 16 to June 25, resulted in a Form 483 with seven observations. The company stated it will address the observations within the required timeline. The filing noted that the facility had previously undergone inspections disclosed in October 2023 and September 2025.

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By Mrinalika Roy and Sriparna Roy

June 17 (Reuters) - U.S. supplies of progesterone are coming under strain, with patients, clinicians, and pharmacists reporting recent intermittent shortages of oral versions of the hormone used in many fertility and menopause treatments.

The supply concerns come as women going through menopause across the country are already facing difficulties filling prescriptions for estrogen patches, another commonly used hormone therapy.

Demand for hormone replacement therapy, or HRT, has climbed sharply since the U.S. Food and Drug Administration removed a longstanding safety warning from many such therapies in late 2025. Doctors have also become more comfortable prescribing HRT, while women's health and menopause experts on social media platforms have encouraged its use.

That has combined to produce tight supplies of progesterone, often prescribed to reduce the risk of uterine cancer, alongside estrogen for relief of menopause symptoms such as hot flashes, mood changes and osteoporosis.

Robin Wilson, 64, director of operations for the Iowa State wrestling program, said progesterone capsules became more difficult to get about a year ago after nearly nine years without supply issues.

Her local pharmacy in Ames, Iowa, recently could not fill her usual 90-day prescription, offering instead a smaller supply while awaiting a shipment. "This is the first time this has happened," Wilson said.

SUPPLIES TIGHTEN WITH DEMAND SURGE

Progesterone-containing HRT prescriptions for women aged 45 and older have more than tripled since January 2021, to about 12 women per 1,000 in May of 2026, according to health analytics company Truveta, whose electronic health record database covers more than 130 million patients in all 50 states.

Prescribing rates have increased more than 19% since the FDA's label change, the data showed.

"While estrogen patches are incurring the biggest supply challenges, progesterone supplies are beginning to be stretched too," said Dr. Kathleen Jordan, chief medical officer of telehealth provider Midi Health.

The American Society of Health-System Pharmacists lists certain oral progesterone capsule products from Amneal Pharmaceuticals AMRX.O and Hikma Pharmaceuticals HIK.L in its shortages database.

"We have seen increased demand for progesterone capsules in recent months," said Amneal, adding that it is increasing manufacturing capacity at its New York facility and continues to meet contracted supply commitments.

Hikma did not respond to requests for comment.

A spokesperson for CVS Health CVS.N, one of the nation's largest pharmacy chains, said manufacturers have been unable to provide sufficient HRT supplies for several months.

According to an FDA database, nine companies manufacture oral progesterone, including Teva TEVA.TA and Dr. Reddy's REDY.NS. Teva did not respond to a request for comment, while Dr. Reddy's said the product has not been part of its U.S. portfolio since 2022 and the company does not manufacture or market it.

The FDA does not list progesterone as being in shortage.

A spokesperson for the U.S. Department of Health and Human Services, which oversees the FDA, said one manufacturer is experiencing delays but others have product available. The agency is working with manufacturers to help ensure supplies meet demand, the spokesperson said.

COMPOUNDING CAUTION

Clinicians say progesterone shortages have been milder than those affecting estrogen patches, though some patients still face delays getting prescriptions filled.

This is partly because women who have had a hysterectomy do not need progesterone with HRT, and because alternatives like combination patches, progestin-releasing IUDs, and oral progestins reduce reliance on any single formulation.

Manufacturers have not disclosed a specific cause for shortages, said Michael Ganio, senior director of pharmacy practice and quality at ASHP, the pharmacists' trade group.

"Without a reason, it can be difficult to know whether there is disruption due to manufacturing or other delays, or an increase in demand that the available market supply cannot meet," Ganio said.

Some have turned to compounding pharmacies for progesterone and estrogen, said Valerie Richards, director of clinical services at Strive Compounding Pharmacy.

"Providers are not waiting for the commercial supply chain to sort itself out," she said.

Compounding pharmacies do their own preparation of pharmaceutical ingredients, which is allowed when the FDA has declared a drug in shortage or for personalized doses not otherwise available.

Dr. Gillian Goddard, adjunct assistant professor of medicine at the NYU Grossman School of Medicine, said compounded products not subject to the strict regulatory process of FDA-approved drugs "could contain too much or too little progesterone," leading to health issues and potentially costly ultrasounds and biopsies.

"I always caution against using compounded products," she said.

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

(([email protected];))

Recasts paragraph 1, 2; updates headline

June 15 (Reuters) - Global drugmakers are expanding their U.S. footprint, pledging billions of dollars to ramp up manufacturing capacity and research in the country.

Pharmaceutical companies including Eli Lilly, Pfizer, AstraZeneca and Roche have announced roughly $500 billion in U.S. investments as they seek to strengthen infrastructure, mitigate supply-chain risks and reassure investors.

Pfizer PFE.N

Pfizer reached a deal with President Donald Trump on September 30 to invest $70 billion in research and development and domestic manufacturing, and received a three-year grace period exempting its products from the pharmaceutical-targeted tariffs.

GSK GSK.L

The London-based drugmaker plans to invest $30 billion in U.S. research and development and supply chain infrastructure over five years.

Eli Lilly LLY.N

U.S. President Donald Trump said in January that Eli Lilly plans to build six plants in the United States.

Lilly said last year that it planned to spend at least $27 billion to build four U.S. plants to expand production and bolster medical supply chains. The company has since announced details on three plants, in Alabama, Virginia and Texas.

Lilly in January said it will build a $3.5 billion pharmaceutical manufacturing facility in Pennsylvania, its fourth new site, in an effort to expand U.S. production and bolster medical supply chains.

Johnson & Johnson JNJ.N

The drugmaker plans to raise U.S. investments by 25%, totaling $55 billion, over the next four years. It plans to build four plants, including one at Wilson, North Carolina, and another at Tokyo-based Fujifilm Biotechnologies' manufacturing site in Holly Springs, North Carolina, over the next 10 years.

The company said in June it has invested about $1 billion in Jacksonville, Florida, to strengthen U.S.-based manufacturing for its eye care business. The new facility is expected to be fully operational in 2028, J&J said.

Roche ROG.S

The Swiss drugmaker said in April last year it would invest $50 billion in the U.S. over the next five years.

A month later, it announced an additional $550 million investment to expand its Indianapolis diagnostics manufacturing hub. The expansion will span Indiana, Pennsylvania, Massachusetts, and California, creating more than 12,000 jobs.

In January, Roche said it will more than double its investment in its drug manufacturing facility in Holly Springs, North Carolina, to about $2 billion, up from the over $700 million announced in May 2025.

AstraZeneca AZN.L

The Anglo-Swedish drugmaker will invest $50 billion on U.S. manufacturing by 2030. The investment will fund a new drug substance facility in Virginia, its largest single-site global investment, alongside expansions in Maryland, Massachusetts, California, Indiana and Texas.

It has already started technology transfers and is managing inventory in 2025 to minimize any tariff hit. Company executives have said the impact would be "very short-lived."

Novartis NOVN.S

The Swiss drugmaker plans to spend $23 billion to build and expand 10 facilities in the U.S. over the next five years. This includes building six new manufacturing plants and expanding its San Diego research and development site, which is expected to create more than 1,000 jobs.

Sanofi SASY.PA

The French drugmaker plans to invest at least $20 billion in the U.S. through 2030 to boost manufacturing and research. Sanofi plans to expand its U.S. manufacturing capacity through direct investments in the company's sites and partnerships with other domestic manufacturers.

Chief Financial Officer François Roger said in July the potential tariffs are expected to have a limited impact in 2025, as the company already has inventory in place in the U.S.

Biogen BIIB.O

The U.S. drugmaker will invest $2 billion more in its existing manufacturing plants in North Carolina, adding capacity for gene-targeting therapies and automation. The company has seven factories in the state, with an eighth set to begin operations in late 2025.

Merck MRK.N

The U.S. drugmaker has begun building a $3 billion pharmaceutical manufacturing plant in Virginia as part of its over $70 billion investment to expand domestic manufacturing and research and development.

It will also invest $1 billion in a new Delaware plant to make biologics and cancer drug Keytruda, to boost U.S. production and potentially create over 4,500 jobs. It also opened a $1 billion facility at its North Carolina site in March.

Merck's animal health unit will invest $895 million to expand its Kansas manufacturing and R&D site, part of a broader $9 billion U.S. investment through 2028.

CEO Robert Davis in July flagged minimal impact from potential tariffs in 2025, and that the company remained well-positioned due to inventory management and moving of manufacturing to the U.S.

Amgen AMGN.O

The U.S.-based biopharma firm plans to invest $900 million to expand its Ohio manufacturing facility, bringing total investment in the state to $1.4 billion and adding 750 jobs. In December, the company committed $1 billion to build a second facility in Holly Springs, North Carolina.

Amgen said in September it is investing more than $600 million to build a new research and development center at its headquarters in Thousand Oaks, California.

The drugmaker announced it will invest $650 million to expand drug manufacturing at its facility in Juncos, Puerto Rico, a move expected to create nearly 750 jobs.

Amgen said it would invest an additional $300 million in its U.S. manufacturing network, expanding its biologics facility in Puerto Rico and support hundreds of construction jobs.

Novo Nordisk NOVOb.CO

The Danish pharmaceutical company said in August its strong U.S. manufacturing footprint positions it well for tariff challenges, describing itself as "very U.S.-centric and U.S.-focused".

AbbVie ABBV.N

U.S. drugmaker AbbVie ABBV.N said in January it has committed $100 billion over the next decade to U.S.-based research and development as part of its three-year deal with the Trump administration to reduce drug prices.

It has 11 manufacturing sites in the U.S. and has said it is "fairly insulated" from any tariff impact this year, given inventory management actions.

The company said in February that it plans to invest $380 million to build two manufacturing facilities at its current North Chicago, Illinois, campus, to support the production of its neuroscience and obesity medications.

Gilead Sciences GILD.O

Earlier this year, the drugmaker announced $11 billion in new planned investment in the U.S. to add to its domestic manufacturing and research heft, taking its total pledged investment to $32 billion.

Gilead said in September that it started work on a pharmaceutical development and manufacturing hub at its headquarters in Foster City, California, in addition to which, it is currently developing two other sites.

Cipla CIPL.NS

The Indian drugmaker is expanding its U.S. manufacturing footprint by investing in capacity expansion for complex respiratory products at its advanced facilities in Fall River, Massachusetts, and Central Islip, New York.

CSL CSL.AX

Australia's CSL said in November it would invest $1.5 billion in the U.S. to manufacture plasma-derived therapies, expanding its footprint in the country over the next five years.

In March, the company announced the expansion of its plasma therapy manufacturing facility in Kankakee, Illinois, which is expected to be operational by 2031.

(Reporting by Siddhi Mahatole, Kamal Choudhury, Puyaan Singh, Sneha S K, Sahil Pandey and Mariam Sunny in Bengaluru; Editing by Tasim Zahid, Sahal Muhammed, Shinjini Ganguli and Maju Samuel)

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June 13 (Reuters) - Dr Reddy's Laboratories Ltd REDY.NS:

• DR REDDY'S - ANNOUNCES THE FIRST-TO-MARKET LAUNCH OF BOSUTINIB TABLETS 400MG IN THE UNITED STATES

Source text: ID:nPLXQ94HLR

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