Zydus Lifesciences

Zydus Lifesciences, RK Pharma sign deal for licensing, commercialisation

Zydus Lifesciences Ltd on Wednesday said it has entered into an exclusive licensing and commercialisation agreement with RK Pharma Inc of the US for a new sterile injectable oncology supportive care product for the US market. Under the terms of this agreement, RK Pharma will manufacture and supply the finished product, while Zydus will be responsible for the NDA (new drug application) submission and commercialisation of the product in the US, the company said in a regulatory filing. The product is expected to be filed in 2026 and will provide a formulation that is intended to provide reduced dosing error and enhanced compliance of healthcare professionals, it added. "This partnership reinforces our commitment to delivering high-quality, affordable medicines and improving patient care," Zydus Lifesciences Managing Director Sharvil Patel said. RK Pharma Founder and Executive Chairman Ravishanker Kovi said, "Our collaboration with Zydus, a company with robust regulatory expertise and

Zydus Lifesciences shares rise after USFDA nod, RK Pharma licensing deal

Zydus Lifesciences gained 2 per cent after securing USFDA approval for Verapamil ER tablets and signing an exclusive deal with RK Pharma

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Neuland, Lupin, Divi's lead domestic, CDMO surge amid US generics headwinds

Analysts noted that while US generics face margin headwinds, domestic formulations and CDMOs remain resilient. Biosimilars are also poised for growth through new launches and regulatory support.

Zydus Lifesciences marks China entry with approval for antidepressant drug

Indian drug cos Chinese pipelines start getting regulator nod; Glenmark got nod for nasal spray this week

Zydus Life Q2: Solid beat on bottom line, analysts mixed on growth outlook

Zydus Life Q2 results review: Foreign brokerage Nomura said Zydus Life delivered results above estimates, led by a stronger-than-expected performance in India.

Zydus PAT up 38% on strong India, US growth; board okays ₹5K cr fundraise

Zydus Lifesciences reported a 17% YoY rise in revenue to Rs 6,123 crore and a 38% jump in profit to Rs 1,258.6 crore in Q2 FY26, driven by India and US formulations performance

Zydus gets USFDA's orphan drug designation for beta-thalassemia product

Zydus Lifesciences on Thursday said the US health regulator has granted Orphan Drug Designation (ODD) to Desidustat, a novel product for the treatment of beta-thalassemia. The US Food and Drug Administration (USFDA) grants orphan status to support development of medicines for the treatment of rare diseases that affect fewer than 2 lakh people in the US. "This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop Desidustat to address beta-thalassemia," Zydus Lifesciences MD Sharvil Patel said in a regulatory filing. Beta thalassaemia patients have low levels of haemoglobin, which results in a lack of oxygen in many parts of the body, leading to weakness, fatigue and more serious complications. Treatment for people with beta thalassaemia often requires lifelong regimens of chronic blood transfusions for survival and treatment for iron overload due to the transfusions. Desidustat is a hypoxia inducible factor (HIF)-prolyl hydroxylase inhibitor (PHI) an

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IPA appoints Zydus Lifesciences MD Sharvil Patel as new President

Sharvil Patel takes over as President of IPA from Samir Mehta, with Glenn Saldanha appointed Vice President, as the industry navigates reforms and global challenges

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

ICMR licences multi-stage malaria vaccine 'AdFalciVax' to five companies

The selection of companies was made through an Expression of Interest (EoI) process launched by ICMR in July

Zydus Lifesciences' Q1 dose lifts vitals, but outlook stays fragile

April-June Qtr beat offsets some caution, yet US headwinds cap upside

Zydus Lifesciences Q1 PAT up 5.9% on strong India, int'l formulations biz

The growth was driven by strong performances in the company's domestic and international formulations segments, even as its consumer wellness and US businesses saw muted growth

Zydus Lifesciences Q1 results: Profit up 3% at ₹1466.8 cr, revenue rises 6%

Revenue from operations climbed 5.9 per cent Y-o-Y to ₹6,573.7 crore in Q1 FY26 from ₹6,207.5 crore a year earlier on the back of new drug launches in the US

Zydus gets USFDA approval for a high blood pressure to treat angina

Zydus Lifesciences on Monday said it has received approval from the US health regulator to market a drug used to treat angina and high blood pressure. The company has received final approval from the US Food and Drug Administration (USFDA) for Diltiazem Hydrochloride tablets in strengths of 30 mg, 60 mg, 90 mg, and 120 mg, the drug maker said in a statement. Diltiazem Hydrochloride Tablets are indicated for the management of chronic stable angina and angina due to coronary artery spasm. It belongs to a class of drugs called calcium-channel blockers. Diltiazem works by relaxing blood vessels, which reduces the workload on the heart and increases blood and oxygen supply to the heart muscle. The company said Diltiazem Hydrochloride Tablets will be produced at Zydus Lifesciences' Baddi plant in Himachal Pradesh. As per IQVIA MAT June 2025 data, Diltiazem Hydrochloride Tablets had annual sales of USD 13.9 million in the US.

Zydus Lifesciences up 2% after USFDA nods Diltiazem Hydrochloride tablets

Zydus Lifesciences share price rose 2 per cent, logging an intra-day high at ₹955 per share on BSE after USFDA gave its approval for Diltiazem Hydrochloride Tablets.

Dr Reddy's Labs, Lupin: Nifty Pharma slips 2% amid Trump tariff jitters

Nifty Pharma index declined 1.5 per cent in trade after US President Donald Trump warned to impose a 25 per cent tariff on Indian goods starting August 1

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.