Page 6 - Zydus Lifesciences

Zydus Life gets USFDA approval to market heart failure treatment drug

Zydus Lifesciences Ltd on Wednesday said it has received final approval from the US health regulator to market its generic Sacubitril and Valsartan tablets combination used to treat chronic heart failure in adults. The approval by the US Food and Drug Administration (USFDA) is to market Sacubitril and Valsartan tablets of strengths 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg, Zydus Lifesciences said in a regulatory filing. Sacubitril and Valsartan combination is used to treat chronic heart failure in adults to help reduce the risk of death and hospitalisation. The drug will be manufactured at the group's formulation manufacturing facility in Moraiya, Ahmedabad, the company added.

Healthcare at new high; Lupin, Glenmark among 5 stocks for up to 15% upside

5 breakout pharma stocks: Glenmark, Lupin, Laurus Labs, Dr Lal PathLabs and Zydus Life can potentially rally up to 15 per cent, suggest charts.

Buzzing stocks today, July 1: Auto, Tata Consumer, HDFC Life, NTPC, Pharma

Stocks to Watch, Monday, July 1, 2024: Shares of Bajaj Auto, Maruti Suzuki India, Tata Motors, M&M, among other automobile stocks will be in focus amid the announcement of June auto sales data

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.

Pricing challenge in US biz, rich valuations may weigh on pharma stocks

Among individual players, Aurobindo Pharma, Dr Reddys Labs, and Zydus Lifesciences sourced 48 per cent, 47 per cent, and 46 per cent of their total revenues from the US generics segment, respectively

Concor, Dixon: Trading strategies for stocks with high long buildup in F&O

F&O stock update for May expiry: Page Industries, Concor, Dixon, Metropolis, Crompton Greaves and Zydus Life have seen notable long buildup in recent days. Here's a short-term outlook on the stocks.

Zydus Lifesciences stock rallies 5%; hits record high on robust Q4 results

EBITDA margin for the quarter stood at 29.5 per cent, an improvement of 440 bps on a YoY basis.

Stocks to Watch, May 18: Vodafone Idea, ZEE, Delhivery, Sobha, Zydus Life

Stocks to Watch on Saturday, May 18, 2024: Vodafone Idea is directing capital expenditure towards enhancing its 4G service coverage, aiming to expand its subscriber base

Zydus Lifesciences Q4 results: Profit rises four-fold to Rs 1,179 crore

On a sequential basis, the company exhibited a 22.83 per cent increase in revenue, the PAT also rose by 53.57 per cent

Zydus Lifesciences Q4 results: Net profit sees 4-fold jump at Rs 1,182 cr

Indian generic drugmakers, which draw a significant share of revenue from the crucial U.S. market, are recovering from the effects of eroding prices in the largest drug market in the world

Zydus, MSN partner to license, supply affordable cancer tablets in the US

MSN Lab will manufacture and supply Cabozantinib; Zydus will handle marketing, distribution and sales

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

Zydus Wellness Q4: Net profit up 3.44% to Rs 150 cr, revenue at 782 cr

Zydus Wellness Ltd on Tuesday reported a 3.44 per cent rise in consolidated net profit at Rs 150.3 crore in the fourth quarter ended March 31, 2024. The company had posted a consolidated net profit of Rs 145.3 crore in the same quarter of the previous fiscal, Zydus Wellness said in a regulatory filing. Consolidated total revenue from operations in the quarter under review stood at Rs 782.6 crore, as against Rs 713 crore in the corresponding period a year ago, it said. Total expenses were higher at Rs 632.2 crore in the fourth quarter of financial year 2023-24, as compared to Rs 580.2 crore in the year-ago period. For the fiscal ended March 31, 2024 consolidated net profit was at Rs 266.9 crore, as against Rs 310.4 crore in the previous fiscal, the company said. In FY24, consolidated total revenue from operations stood at Rs 2,327.8 crore, as compared to Rs 2,254.8 crore in FY23. The board of directors at their meeting held on May 14, 2024 recommended a final dividend Rs 5 per equ

Stocks to watch on May 13: TaMo, ICICI Bank, BEML, JK Cement

BEML's Q4 earnings showcased strong growth, with net profit soaring 62.8 per cent year-on-year (YoY) to Rs 256.8 crore.

Stocks to watch on May 6: Tata Power, Sun Pharma, Zydus Life, Nerolac

Stocks to watch, Monday, May 6: Jammu and Kashmir Bank on Saturday reported its highest-ever annual profit at Rs 1,767 crore for 2023-24

Zydus Life stock: When to book profit? Advice from HDFC Sec's Nandish Shah

Price rise is accompanied by the rise in the volume, suggesting strength in the uptrend. Stock price has broken out on the daily chart with higher volumes to close at highest level since 10 April 2024

Zydus Lifesciences unit gets 10 observations from USFDA after inspection

Zydus Lifesciences on Wednesday said the US health regulator has issued ten observations after inspecting its injectable manufacturing plant near Vadodara in Gujarat. The US Food and Drug Administration (USFDA) inspected the facility at Jarod near Vadodara from April 15 to April 23, the drug maker said in a regulatory filing. The inspection closed with ten observations, it added. The company will closely work with the USFDA to address and respond to the observations in an expeditious manner, Zydus Lifesciences said. Shares of the company were trading 2.79 per cent down at Rs 932.80 apiece on the BSE.

Zydus Life stock sheds 5% as USFDA issues 10 observations for Vadodara unit

Zydus Lifesciences share price update: The USFDA conducted an inspection at the Injectable Manufacturing site situated at Jarod, near Vadodara, between April 15 and April 23, 2024

Zydus Lifesciences gets China nod for drug to treat CKD-linked anaemia

It is estimated that more than 120 million people are living with chronic kidney disease in China

Zydus Lifesciences launches generic drug for overactive bladder in US mkt

Zydus Lifesciences on Monday said it has launched a generic medication to treat overactive bladder in the US market. The company has launched Mirabegron extended-release tablets in strength of 25 mg in the US market after having received final approval from the US Food and Drug Administration (USFDA), Zydus Lifesciences said in a regulatory filing. Zydus is among the first suppliers to launch the generic version of Mirabegron extended-release tablets (USP 25 mg) in the US market. The company is also preparing to launch the 50 mg tablets in the market, it added. Mirabegron is indicated for the treatment of Overactive Bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. The drug will be manufactured at the Zydus group's formulation manufacturing facility in Ahmedabad SEZ, India, the drug maker said. Zydus CEO Americas, Punit Patel said the launch of generic Mirabegron will improve access and availability of the generic product for patients in the