Zydus Pharmaceuticals

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

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

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

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 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 ...

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 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 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 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

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 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.

Zydus Lifesciences Ltd on Friday said it has received final approval from the US health regulator to manufacture and market its generic Isosorbide Mononitrate extended-release tablets used to prevent chest pain in patients with a certain heart condition. The approval by the US Food and Drug Administration (USFDA) is to manufacture and market Isosorbide Mononitrate Extended-Release, of strengths 30 mg, 60 mg, and 120 mg, Zydus Lifesciences said in a regulatory filing. Isosorbide mononitrate is used to prevent chest pain (angina) in patients with a certain heart condition, coronary artery disease, it added. The product will be manufactured at the group's formulation manufacturing facility at Ahmedabad SEZ, the company said. Isosorbide Mononitrate extended-release tablets 30 mg, 60 mg, and 120 mg had annual sales of USD 47 million in the US, Zydus said citing IQVIA December 2023 data. PTI RKL.

Zydus Group on Friday announced plans to invest Rs 5,000 crore in Gujarat in various sectors, including new generation biotechnology products and hospitals, its Chairman Pankaj Patel said. Speaking at the 10th Vibrant Gujarat Global Summit here, Patel said his group has signed Memoranda of Understanding (MoUs) with the state for the investments. "We have signed MoUs of over Rs 5,000 crore. We'll be investing into next generation biotechnology products, new medical device initiatives and hospitals for the healthcare sector," he said. Patel said he has been attending the biennial summit since its inception and thanked Prime Minister Narendra Modi and Union Home Minister Amit Shah for helping businesses when it needs it the most. He said business needs leadership with a vision and the one that pushes it to think bigger, which is offered in Gujarat. Earlier, Nayara Energy's head of refinery Prasad Panicker said the company will be expanding its refinery at Vadinar and also upping its

Zydus Lifesciences on Saturday said it has received approval from the US health regulator to market a generic anti-epileptic medication. The company has received approval from the US Food and Drug Administration (USFDA) to manufacture and market Lacosamide Tablets in multiple strengths, the drug firm said in a statement. Lacosamide is indicated to treat partial-onset seizures. It is also used with other medicines to treat primary generalized tonic-clonic seizures. The company said it will manufacture the product at the group's formulation manufacturing facility in Moraiya, Ahmedabad. As per IQVIA data, Lacosamide Tablets had annual sales of USD 249 million in the US.

Daewoong will leverage its proprietary technology to produce Leuprolide Acetate for Depot Suspension in its manufacturing facilities located in Osong, South Korea

The company said that Zituvimet has undergone quality testing for Nitrosamines and potential genotoxic impurities according to current FDA standards

The company has received the approval from Therapeutic Goods Administration (TGA)

The industry and the government are on the same page on trade margin rationalisation, however, the industry wants it to be implemented in a phased manner

Zydus Lifesciences on Friday said it has launched generic epilepsy treatment medication in the US market. Zydus Pharmaceuticals (USA) Inc, a unit of the company, has launched Topiramate extended-release capsules in the American market. The company had earlier received final approval from the US Food and Drug Administration (USFDA) to market the product in strengths of USP 25 mg, 50 mg, and 100 mg, Zydus Lifesciences said in a statement. Zydus is the first company to receive final approval and launch the medication in the above mentioned strengths, it added. Topiramate extended-release capsules are indicated for epilepsy: initial monotherapy in patients who are six years of age and older with partial onset or primary generalized tonic-clonic seizures. It is also indicated for prophylaxis of migraine in patients 12 years of age and older. As per IQVIA data, Topiramate extended-release capsule had annual sales of USD 488 million in the US.

Zydus Lifesciences on Monday said it has received an approval from the DCGI for Oxemia (Desidustat), a first-of-its-kind oral treatment for anaemia associated with chronic kidney disease