Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) to market Valsartan Tablets USP, 40 mg, 80 mg, 160 mg and 320 mg (USRLD: Diovan' tablets). Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and paediatric patients one year of age and older. It is also used in adults to treat heart failure (a condition in which the heart is unable to pump enough blood to the rest of the body) and to improve survival after a heart attack. The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India.Powered by Capital Market - Live

The key domestic indices traded with limited losses in the mid-afternoon trade after the Budget for 2024-25 was laid down in the Parliament by the Finance Minister. The Nifty traded below the 24,500 mark after hitting the day's high of 24,582.55 in early trade. PSU bank shares declined after advancing in the past trading session. At 14:30 IST, the barometer index, the S Rs 3 lakh to Rs 7 lakh will be taxed at 5%; Rs 7 lakh to Rs 10 lakh will be taxed at 10%; Rs 10 lakh to Rs 12 lakh will be taxed at 15%; Rs 12 lakh to Rs 15 lakh will be taxed at 20%; and income above Rs 15 lakh will be taxed at 30%. The Securities Transaction Tax (STT) on futures and options (F&Os) is proposed to be increased to 0.02% and 0.01%, respectively. Additionally, the Finance Minister states that long-term capital gains on all financial and non-financial assets will be taxed at a rate of 12.5%. The limit of exemption for capital gains will be set at Rs 1.25 lakh per year. Listed financial assets held for more than a year will be classified as long term. The FM states that the union government will target a fiscal deficit of 4.9% of the gross domestic product (GDP) for FY25, compared to the 5.1% target set in the interim budget. Gross borrowing is targeted at Rs 14.01 lakh crore, with market borrowing at Rs 11.06 lakh crore. The fiscal deficit target for FY26 is set at 4.5% of GDP. Sitharaman notes that the government will maintain strong fiscal support for infrastructure, allocating Rs 11.11 lakh crore for capital expenditure, amounting to 3.4% of India's GDP. The government also allocates Rs 1.52 lakh crore for agriculture and allied sectors. The Finance Minister emphasizes expanding the space economy by five times over the next 10 years, supported by a venture capital fund of Rs 1,000 crore. GST has significantly reduced tax incidents for the common man and eased compliance for industry. To enhance the benefits of GST, the government will strive to rationalize the tax structure. The Finance Minister adds that rules and recognition for Foreign Direct Investments (FDIs) will be simplified to facilitate their inflow, aiming to promote the use of the Rupee for overseas investments. Sitharaman also proposes supporting the development of corridors at Vishnupad Temple and Mahabodhi Temple, following the model of the Kashi Vishwanath Temple, and backing the development of Nalanda in Bihar as a tourist center. An economic policy framework will be introduced to usher in next-generation reforms aimed at boosting economic growth. Additionally, the government will provide assistance to Odisha for the development of tourism. Buzzing Index: The Nifty PSU Bank index fell 1.63% to 7,202.35. The index rose 0.26% in the past trading sessions. Punjab & Sind Bank (down 4.06%), UCO Bank (down 2.69%), Indian Bank (down 2.48%), Indian Overseas Bank (down 2.01%), Bank of India (down 1.69%), Bank of Maharashtra (down 1.53%), Central Bank of India (down 1.41%), Canara Bank (down 1.39%), State Bank of India (down 1.35%) and Union Bank of India (down 1.34%) slipped. Numbers to Track: The yield on India's 10-year benchmark federal rose 0.07% to 6.972 as compared with previous close 7.094. In the foreign exchange market, the rupee lower against the dollar. The partially convertible rupee was hovering at 83.6950, compared with its close of 83.6675 during the previous trading session. MCX Gold futures for 5 August 2024 settlement shed 0.12% to Rs 72,900. The US Dollar index (DXY), which tracks the greenback's value against a basket of currencies, was down 0.03% to 104.28. The United States 10-year bond yield fell 0.47% to 4.241. In the commodities market, Brent crude for September 2024 settlement added 32 cents or 0.39% to $82.72 a barrel. Stock in Spotlight: Zydus Lifesciences shed 0.37%. The pharma major announced that it has received final approval from the United States Food and Drug Administration (USFDA) to market Valsartan tablets. Powered by Capital Market - Live

The approved tablet is reference listed drug of Diovan tablets. Valsartan tablets are indicated for the treatment of hypertension, to lower blood pressure in adults and paediatric patients one year of age and older. It is also used in adults to treat heart failure (a condition in which the heart is unable to pump enough blood to the rest of the body) and to improve survival after a heart attack. The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad, India. According to IQVIA MAT May 2024, Valsartan tablets had annual sales of $149.5 million in the United States. The group now has 400 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04. Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The scrip fell 0.26% to currently trade at Rs 1,151.45 on the BSE. Powered by Capital Market - Live

Bhava (Bevacizumab) 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. As per a WHO report of 2020, out of the total cancer cases reported in Mexico, breast, prostate, colorectal and thyroid were amongst the common cancer cases registered. Zydus had developed and launched the Bevacizumab biosimilar developed in-house by the research team at the Zydus Research Centre (ZRC) in 2015 in India under the brand name Bryxta.  Since then, an estimated 50,000 patients have been treated with the therapy. With twelve lifesaving biosimilars already launched in the market, Zydus has been bridging the unmet need for affordable therapies in the fight against cancer in India. Dr. Sharvil Patel, managing director, Zydus, said, 'We welcome the approval granted to the first of our biosimilars for patients in Latin America. To bring in greater access and affordability to patients battling critical ailments, we have been developing a pipeline of biosimilars, specifically in oncology. Precision diagnostics and access to affordable therapies are empowering millions of patients in their fight against cancer in India. With Bhava, we begin a new journey of supporting patients with need-based therapies in Latin America.'  Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The pharma major reported consolidated net profit of Rs 1,182.3 crore in Q4 FY24 steeply higher than Rs 296.6 crore recorded in Q4 FY23. Revenue from operations jumped 10.44% to Rs 5,533.8 crore during the quarter as compared with Rs 5,010.6 crore posted in corresponding quarter last year. Powered by Capital Market - Live

Zydus Lifesciences'announced that the Mexican regulatory authority COFEPRIS (Federal Commission for the Protection Against Sanitary Risk), has granted marketing approval for Bhava™, a Bevacizumab biosimilar. Bhava™ (Bevacizumab), will be marketed in different strengths of 100 mg/4 ml and 400 mg/16 ml and 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. As per a WHO report of 2020, out of the total cancer cases reported in Mexico, breast, prostate, colorectal and thyroid were amongst the common cancer cases registered. Powered by Capital Market - Live

Zydus Lifesciences announced that the USFDA conducted an inspection at the group's transdermal manufacturing site located at SEZ in Ahmedabad. The inspection was conducted from 15 July to 19 July 2024. The inspection closed with 2 observations. The Company is confident of addressing the issues raised by the USFDA within the stipulated timeline, and is committed to resolving the same at the earliest.Powered by Capital Market - Live

Zydus Lifesciences has received final approval for its New Drug Application (NDA) from the United States Food and Drug Administration (USFDA) to market Zituvimet XR (sitagliptin and metformin hydrochloride) extended-release tablets. With this, Zydus has all three NDAs of Sitagliptin (base) and combination franchise approved through the 505(b)(2) route. Notably, all the three NDAs achieved First-Cycle Approval (FCA). Zituvimet XR (sitagliptin and metformin hydrochloride) extended-release tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The product will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ, India.Powered by Capital Market - Live

With this, Zydus has all three NDAs of sitagliptin (base) and combination franchise approved through the 505(b)(2) route. Notably, all the three NDAs achieved first-cycle approval (FCA), it added Zituvimet XR tablets (sitagliptin and metformin hydrochloride) are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. The drug will be manufactured at the group's formulation manufacturing facility in Ahmedabad SEZ - II, India. According to IQVIA MAT May 2024, U.S. market for DPP-IV inhibitors and its combinations is $9.5 billion. Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The pharma major reported consolidated net profit of Rs 1,182.3 crore in Q4 FY24 steeply higher than Rs 296.6 crore recorded in Q4 FY23. Revenue from operations jumped 10.44% to Rs 5,533.8 crore during the quarter as compared with Rs 5,010.6 crore posted in corresponding quarter last year. Shares of Zydus Lifesciences declined 2.33% to currently trade at Rs 1,157.70 on the BSE.Powered by Capital Market - Live

Zydus Lifesciences informed that it has received a report from the United States Food and Drug Administration (USFDA) for the inspection conducted at its injectables manufacturing facility located at Jarod, near Vadodara, Gujarat. Post inspection, the US FDA classified the facility as 'Official Action Indicated' (OAI). The company said that it will work closely with the agency to resolve the regulatory status of this facility expeditiously. Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The pharma major reported consolidated net profit of Rs 1,182.3 crore in Q4 FY24 steeply higher than Rs 296.6 crore recorded in Q4 FY23. Revenue from operations jumped 10.44% to Rs 5,533.8 crore during the quarter as compared with Rs 5,010.6 crore posted in corresponding quarter last year. The scrip fell 2.35% to currently trade at Rs 1,157.40 on the BSE. Powered by Capital Market - Live

Zydus Lifesciences will hold a meeting of the Board of Directors of the Company on 9 August 2024.Powered by Capital Market - Live