Zydus Pharmaceuticals

Dr Reddy's, Zydus recall products in US over manufacturing issues: USFDA

Drug majors Dr Reddy's Laboratories and Zydus Lifesciences are recalling products in the US for manufacturing issues, according to the US health regulator. In its latest Enforcement Report, US Food and Drug Administration (USFDA) stated that an American subsidiary of the Hyderabad-based drug major is recalling 571 vials of an injection used to relax muscles. Princeton-based Dr Reddy's Laboratories, Inc is recalling the affected lot of Succinylcholine Chloride Injection due to "Out-of-Specification result during the six-month stability testing," the USFDA stated. The company initiated the nationwide (US) Class II recall on September 26 this year. The USFDA stated that US-based arm of Zydus Lifesciences is recalling over 1,500 boxes of an antiviral medication used primarily to treat chronic hepatitis B virus. Pennington, New Jersey-based Zydus Pharmaceuticals (USA) Inc is recalling 912 and 600 bottles of Entecavir tablets in strengths of 0.5 mg and 1 mg respectively due to "failed .

Glenmark, Zydus recall products in US over manufacturing issues: USFDA

Domestic drugmakers Glenmark, Granules India, Sun Pharma, Zydus and Unichem are recalling products in the US market for various manufacturing issues, according to the US Food and Drug Administration (USFDA). The drugmakers are voluntarily recalling affected lots in the American market, the US health regulator said in its latest Enforcement Report. A US-based subsidiary of the Mumbai-based Glenmark Pharmaceuticals is recalling 13,824 Azelaic Acid Gel tubes produced at the company's Goa plant due to "CGMP deviations" following market complaints received for gritty texture, USFDA said. New Jersey-based Glenmark Pharmaceuticals Inc, USA, initiated the Class II nationwide recall on September 17. As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal. Hyderabad-based Granules India is recalling over 49,000

Zydus Lifesciences growth aided by acquisitions, but execution risks loom

Zydus Lifesciences trades near 52-week highs on strong growth and acquisitions but analysts caution that rapid expansion and diversification may pose execution challenges

Zydus Lifesciences gets tentative USFDA nod for generic blood cancer drug

Zydus Lifesciences Ltd on Thursday said it has received tentative approval from the US health regulatory agency for its generic version of cancer treatment drug Ibrutinib tablets. The tentative approval granted by the US Food and Drug Administration (USFDA) is for Ibrutinib tablets of strengths 140 mg, 280 mg, and 420 mg, Zydus Lifesciences said in a statement. The Ibrutinib tablets will be produced at Zydus Lifesciences Ltd SEZ, Ahmedabad, it added. The company said Ibrutinib is indicated for the treatment of adult patients with different types of blood cancers, Chronic lymphocytic leukaemia (CLL)/Small lymphocytic lymphoma (SLL), and Waldenstrom's macroglobulinemia (WM). Citing IQVIA MAT May 2025, Zydus said Ibrutinib tablets had annual sales of USD 2148.9 million in the US.

Zydus gets USFDA approval for generic drug to treat multiple sclerosis

Zydus Lifesciences on Friday said it has received approval from the US health regulator to market a generic medication to treat multiple sclerosis. The company has received approval from the US Food and Drug Administration (USFDA) for Glatiramer Acetate Injection, 20 mg/mL and 40 mg/mL, single-dose prefilled syringes. The company's product is the generic version of Copaxone which is indicated for the treatment of relapsing forms of Multiple Sclerosis (MS). Zydus said the product, developed in collaboration with Chemi S.p.A., will be manufactured entirely in Europe. "This approval underscores Zydus' leadership in bringing complex, differentiated generics to market, reinforcing our commitment to providing a comprehensive range of therapeutic choices for patients," Zydus Lifesciences MD Sharvil Patel said. As per IQVIA MAT data, Glatiramer Acetate Injection had annual sales of USD 719 million in the US market. Shares of Zydus Lifesciences were trading 0.48 per cent up at Rs 876 apie

Medicines are just one part of the solution: Zydus' Sharvil Patel

Zydus MD Sharvil Patel says the company is going beyond pharma into med-tech, diagnostics, and rare diseases, aiming for a global footprint while retaining India as the manufacturing hub

Glenmark, Sun Pharma, Zydus recall products in US over manufacturing issues

Drug makers Glenmark, Sun Pharma and Zydus are recalling products in the US for manufacturing issues, the US Food and Drug Administration (USFDA) said in its latest Enforcement Report. As per the US health regulator, Mumbai-based Glenmark is recalling over 25 products in the US market due to Current Good Manufacturing Practice (CGMP) deviations. New Jersey-based Glenmark Pharmaceuticals Inc is recalling affected lots of medications like Propafenone Hydrochloride extended-release capsules and Solifenacin Succinate Tablets in America, the USFDA said. It is also recalling products like Voriconazole Tablets, Lacosamide Tablets, Frovatriptan Succinate Tablets and Rufinamide Tablets. The company initiated the Class II recall on March 13 this year. As per the USFDA, a Class-II recall is initiated when the use of, or exposure to, a violative product may lead to temporary or medically reversible health consequences, or when the likelihood of serious adverse health outcomes is minimal. A .

Sun Pharma, Zydus recall medicines in US over quality concerns: USFDA

Sun Pharma and Zydus Pharmaceuticals are recalling products in the US market due to manufacturing issues, according to the US Food and Drug Administration (USFDA). The New Jersey-based Sun Pharmaceutical Industries, Inc is recalling 9,840 bottles of Morphine Sulfate extended-release tablets for "Failed Dissolution Specifications", the US health regulator stated in its latest Enforcement Report. The company initiated the Class II nationwide (US) recall on February 6, 2025. USFDA stated that Zydus Pharmaceuticals (USA) Inc is recalling a lot of Nelarabine Injection, used in the treatment of certain cancers, in the US. The company is recalling 36,978 vials of Nelarabine Injection in strength of 250mg/50mL, (5mg/mL) for "Failed Impurities/ Degradation Specifications," USFDA stated. The company initiated the Class II recall in February. Zydus is also recalling 1,893 vials of the drug in strength of 250mg/50mL, (5mg/mL). The company initiated the Class II nationwide recall on February

Zydus Lifesciences to develop world's first dual vaccine for typhoid

Typhoid and shigellosis remain serious public health threats, particularly in low-resource settings

Zydus launches vaccine for protection against new strain of influenza virus

Zydus Lifesciences on Wednesday said it is introducing a vaccine for protection against new strain of influenza virus. The company is introducing country's first flu protection quadrivalent influenza virus vaccine as per WHO recommended composition, the Ahmedabad-based drug major said in a statement. Zydus's Quadrivalent Inactivated Influenza vaccine VaxiFlu-4 will offer seasonal protection against four new virus strains, it added. A quadrivalent vaccine, by covering strains of both influenza A and influenza B, provides a broader protection and significantly reduces the risk of vaccine mismatch, it said. The vaccine has been cleared by the Central Drug Laboratory (CDL), the drug maker said. "Preventives are the key to public health in both the developing and the developed world and vaccines have the potential to improve the quality of life," Zydus Lifesciences Managing Director Sharvil Patel said. In India, there is a pressing need for access to affordable, high-quality vaccines

Pharma sector can deliver 100 new drugs by 2047: Zydus chairman

Indian pharma industry is capable of delivering 100 new drugs by 2047 for global markets backed by enhanced research and development efforts, Zydus Lifesciences Chairman Pankaj R Patel said on Friday. Speaking at an event here, he stressed the need for innovation, capability building, and a focus on societal benefit. "I believe India can deliver 100 new chemical entities or new drugs to the world by 2047 and off course, it will require effort," Patel said while speaking at the SOUL leadership conclave 2025. He termed it a myth that drug discovery requires a billion dollars while emphasising that it is possible with the right approach. Patel also asserted that the people working in an organisation are the most valuable resource and pitched for an environment where people love to work. He also emphasised the evolving nature of leadership, highlighting the importance of humility, vision, and a global perspective. Patel also shared experiences, including the Prime Minister's proactiv

Zydus Life Q3 results: Net profit jumps 30% to Rs 1,024 cr on strong demand

The United States is the company's biggest market accounting for 47 per cent of total revenue, followed by India

Innovation from India to empower lives: Zydus' Patel on Padma honour

Innovation from India will bring critical access to affordable healthcare and empower people to lead healthier and more fulfilled lives, said Zydus Lifesciences Chairman Pankaj R Patel who has been selected for the prestigious Padma Bhushan award. The government announced the Padma Awards on Saturday on the eve of the 76th Republic Day. President Droupadi Murmu approved conferment of 139 Padma Awards for the year 2025. The list comprises 7 Padma Vibhushan, 19 Padma Bhushan and 113 Padma Shri Awards. The awards are conferred by the President at a ceremonial function at Rashtrapati Bhawan, usually around March-April every year. Thanking the Union government for being chosen for the award, Patel noted that his journey began over seven decades ago when his father started out as an entrepreneur to contribute to nation building and making India self- reliant in lifesciences. Patel stated that he is fortunate to have 27,000 people at Zydus as a part of this journey working on putting Ind

Zydus Wellness arm gets Rs 56.33 cr GST demand over Heinz IP rights deal

Zydus Wellness Ltd on Saturday said its wholly-owned arm has received a GST demand of Rs 56.33 crore, along with applicable interest and penalty from the tax authority. Zydus Wellness Products Ltd (ZWPL), a wholly-owned subsidiary company, has received an intimation from the Directorate General of Goods and Services Tax Intelligence, Surat Zonal Unit, alleging GST demand of Rs 56.33 crore, along with applicable interest and penalty, Zydus Wellness Ltd said in a regulatory filing. The intimation alleges that the GST was payable in relation to the acquisition of intellectual property rights from Heinz Italia S.P.A. by Heinz India Pvt Ltd, now merged with ZWPL, it added. "ZWPL believes that there is a strong merit in the case, and ZWPL is evaluating the next steps based on a detailed review of the intimation," the filing said. The period covered by the order relates to the pre-acquisition period prior to January 30, 2019, the filing said. Due to this order, there is no impact on ...

Aurobindo Pharma, Glenmark, and Zydus recall products in US over mfg issues

Drug makers Aurobindo Pharma, Glenmark and Zydus are recalling products in the US market due to manufacturing issues, according to the US health regulator. As per the latest Enforcement Report of US Food and Drug Administration (USFDA), Aurobindo Pharma USA Inc, a subsidiary of Hyderabad-based drug maker, is recalling over 1 lakh bottles of Cinacalcet tablets in multiple strengths. The New Jersey-based firm is recalling the product due to "GMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit," the US health regulator said. The company initiated the Class II recall on November 7 this year. Cinacalcet tablets are used to treat hyperparathyroidism. Similarly, a US-based subsidiary of Glenmark Pharmaceuticals is recalling around 90,000 bottles of Diltiazem Hydrochloride extended-release capsules (multiple strengths) in the US market. New Jersey-based Glenmark Pharmaceuticals Inc, USA is recalling the affected lot of Diltiazem Hydrochloride ...

Zydus Lifesciences gets Mexican authority nod for cancer remedy biosimilar

Zydus Lifesciences Ltd on Monday said it has received marketing approval from the Mexican regulatory authority for its biosimilar product -- Bhava, used in the treatment of certain types of cancers. Mexican regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk), has granted marketing approval for Bhava, a Bevacizumab biosimilar and it will be marketed in different strengths of 100 mg/4 ml and 400 mg/16 ml, Zydus Lifesciences said in a regulatory filing. Bhava is used in the treatment of metastatic colorectal cancer (mCRC), non-squamous non-small cell lung cancer, metastatic breast cancer, glioblastoma, advanced and/or metastatic renal cell carcinoma and ovarian cancer patients, it added. Zydus Managing Director, Sharvil Patel said the approval granted by COFEPRIS is the company's first biosimilars for patients in Latin America. "To bring in greater access and affordability to patients battling critical ailments, we have been developing a pipelin

Zydus gets tentative nod from USFDA for blood pressure lowering drug

Zydus Lifesciences Ltd on Friday said it has received tentative approval from the US health regulator to market Azilsartan Medoxomil and Chlorthalidone tablets, which are indicated for the treatment of high blood pressure. The tentative approval by the US Food and Drug Administration (USFDA) is for Azilsartan Medoxomil and Chlorthalidone tablets of strengths 40 mg/12.5 mg and 40 mg/25 mg, Zydus Lifesciences said in a regulatory filing. Azilsartan and Chlorthalidone are diuretic combination products indicated for the treatment of high blood pressure to lower blood pressure, it added. The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ- II, India, the company said. Azilsartan Medoxomil and Chlorthalidone tablets had annual sales of USD 77.9 million in the US, Zydus Lifesciences said citing IQVIA MAT March 2024 data.

Zydus Lifesciences inks supply pact with MSN for generic cancer drug in US

Zydus Lifesciences Ltd on Friday announced an exclusive licensing and supply agreement with MSN Laboratories for generic cancer treatment drug Cabozantinib tablets, for the US market. The company's wholly-owned subsidiary, Zydus Lifesciences Global FZE, has entered into an exclusive licensing and supply agreement with MSN Laboratories for Cabozantinib tablets for the US market, Zydus Lifesciences Ltd said in a regulatory filing. Cabozantinib tablet is the generic version of CABOMETYX of Exelixis. Under the agreement, MSN Laboratories will be in charge of manufacturing and supplying the generic version of CABOMETYX, following the receipt of regulatory approval, the company said. Zydus will exclusively market, distribute, and sell the product in the US market, it added. "MSN was a first sole ANDA (abbreviated new drug application) applicant for Cabozantinib tablets, to submit a substantially complete ANDA with a paragraph IV certification and therefore may be eligible for 180 days o

Lupin appoints Jeffrey Kindler, Alfonso 'Chito' Zulueta as independent dirs

Pharma major Lupin Ltd on Thursday announced appointments of ex-Pfizer Chairman and CEO, Jeffrey Kindler and Alfonso 'Chito' Zulueta as independent directors on its board. Kindler is currently the CEO of Centrexion Therapeutics, a privately-held biotechnology company, Senior Advisor to Blackstone, Operating Partner at ARTIS Ventures and Global Chair of GLG Institute, Lupin said in a regulatory filing. He brings over four decades of business experience holding leadership positions at some of the world's most recognised companies, including Pfizer, where he served as Chairman & Chief Executive Officer, as well as McDonald's Corporation and General Electric Company, the company added. Before that, he was a partner at law firm Williams & Connolly. Zulueta currently serves as Non-Executive Chairman of the board of directors of Interpharma Investments Ltd, the holding company of Zuellig Pharma, one of the largest healthcare services groups in Asia, Lupin said. He is also President ..

Zydus Lifesciences' Rs 600 crore buyback offer to open on Feb 29

Zydus Lifesciences on Tuesday said its offer to buy back 59.7 lakh shares at Rs 1,005 apiece, aggregating to Rs 600 crore, will open on February 29. The share repurchase programme will close on March 6, 2024, the drug firm said in a regulatory filing. The company proposed to buy back up to 59,70,149 shares at Rs 1,005 apiece for an aggregate consideration not exceeding Rs 600 crore, it stated. Shares of the company were trading 0.38 per cent up at Rs 946.15 apiece on the BSE.