Page 7 - Zydus Lifesciences

Zydus Lifesciences, Hero Motocorp, NHPC, Bosch in line for largecap upgrade

The Association of Mutual Funds in India (Amfi) announced a revised list of largecap, midcap and smallcap stocks biannually (January and July)

Zydus Lifesciences gets 4 observations from USFDA for Gujarat plant

Zydus Lifesciences on Wednesday said the US health regulator has issued a Form-483 with four observations following the inspection of its Ahmedabad-based SEZ Onco Injectable manufacturing plant. The US Food and Drug Administration (USFDA) conducted the cGMP (Current Good Manufacturing Practice) inspection at the facility from March 18-27, 2024, the company said in a regulatory filing. The inspection closed with four observations, it added. There were no data integrity-related observations, the drug firm said. Zydus will closely work with the USFDA to address the observations, it added. Shares of the company ended 1.82 per cent lower at Rs 999.60 apiece on BSE.

Zydus Life hits new peak; m-cap hits Rs 1 trn as stock up 60% in 3 months

The stock was quoting higher for a fifth straight trading day and has rallied 10 per cent during the period

Zydus Lifesciences announces share buyback of Rs 600 cr; to open on Feb 29

The buyback will open on February 29 and the share repurchase programme will close on March 6, 2024

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.

Zydus Lifesciences gets WHO nod for API used in kala-azar treatment

More than 1 billion people live in areas endemic for leishmaniasis or Kala Azar and are at risk of infection

Domestic business, US launches to drive gains for Zydus Lifesciences

Q3 results better than estimates on the back of higher gross margins

Zydus Lifesciences gets USFDA nod for generic drug to prevent chest pain

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 Lifesciences Q3FY24 results: Profit up 27% at Rs 790 crore

Zydus Lifesciences on Friday said its consolidated net profit increased by 27 per cent to Rs 790 crore in the third quarter ended December 31, 2023. The drugmaker had reported a net profit of Rs 623 crore in the October-December period a year ago. Revenue increased to Rs 4,505 crore in the third quarter from Rs 4,257 crore in the year-ago period, Zydus Lifesciences said in a statement. The company said its board has approved a proposal to buy back shares of up to Rs 600 crore. "We are pleased with our Q3 FY24 performance, particularly with a strong recovery in the domestic formulations business and a resilient US base business," Zydus Lifesciences Managing Director Sharvil Patel said. He further said: "We are optimistic about our growth prospects driven by a differentiated portfolio in the US, continued performance of key brands, well supported by a robust execution engine." The company remains on track to end the fiscal year 2024 with a healthy double-digit revenue growth, Patel

Zydus Lifesciences Q3 result: Net profits rise by 27%, beat estimates

Indian generic drugmaker Zydus Lifesciences reported a bigger-than-expected rise in third-quarter profit on Friday, driven by strong sales in its domestic and overseas markets

Zydus Life, ICICI Bank: Stocks to buy in current market set-up

On the broader market outlook, Vinay Rajani technical & derivative analyst of HDFC Securities says the Nifty has confirmed a bearish trend reversal, and could see further downside in coming days.

Zydus Lifesciences arm gets Rs 284.58 cr income tax demand notice

Zydus Lifesciences on Tuesday said its arm Zydus Healthcare Ltd has been served an income tax notice demand of Rs 284.58 crore for for the assessment year 2023-2024. Zydus Healthcare Ltd (ZHL), a wholly-owned subsidiary, has received an intimation under section 143(1) of the Income Tax Act, 1961 (IT Act), determining demand of Rs 284.58 crore, Zydus Lifesciences said in a regulatory filing. The intimation is for the assessment year 2023-2024 from the CPC, Income Tax Department, it added. The demand is determined due to "apparent mistakes while processing its return of income", it said. "The company strongly believes that once the rectification will be made, the entire demand will be deleted," Zydus Lifesciences said. ZHL has already disagreed with demand on the e-filing portal of the Income Tax Department. It is also going to file Rectification Application under section 154 of the IT Act, before the CPC as well as before the Jurisdictional Assessing Officer against the said ...

Zydus Lifesciences gets six observations from USFDA for API plant

Zydus Lifesciences on Friday said the US health regulator has issued six observations after inspecting its active pharmaceutical ingredient (API) site in Ahmedabad, Gujarat. The US Food and Drug Administration (USFDA) conducted the inspection from December 14 to December 22, 2023. The inspection closed with six observations, Zydus Lifesciences said in a regulatory filing. There were no data integrity related observations, it added. Besides, there are no repeat observations from the previous inspection, it noted. There are four drug master files (DMFs) from the site under approval with the USFDA, the drugmaker said. The company will closely work with the USFDA to address the observations, it added.

Zydus Noveltech dissolved for not generating 'meaningful revenue'

It had nil operating revenue and a net worth of Rs 10 crore as of March 31, 2023

Zydus Noveltech Inc dissolved after 'not generating meaningful revenue'

Dissolution of Zydus Noveltech Inc will not affect the business operations of the company, said Zydus Lifesciences

Zydus Lifesciences gets USFDA nod to sell generic anti-epileptic medication

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.

Zydus gets USFDA's approval for antiviral drug used in HIV treatment

Zydus Lifesciences on Friday said it has received approval from the US health regulator to market a generic antiviral medication used in the treatment of HIV-1 infection. The company has received final approval from the US Food and Drug Administration (USFDA) for Darunavir Tablets, the company said in a statement. Darunavir is a protease inhibitor antiviral medicine that prevents Human Immunodeficiency Virus (HIV-1) from multiplying in the body. It is indicated for the treatment of HIV-1 infection in adult patients. It is also indicated for the treatment of HIV-1 infection in pediatric patients three years of age and older. It must be co-administered with Ritonavir and with other antiretroviral agents. Zydus said the product will be manufactured at the group's formulation manufacturing facility in SEZ, Ahmedabad, Gujarat. As per IQVIA MAT data, Darunavir tablets (75 mg, 150 mg, 600 mg, and 800 mg) had annual sales of USD 275 million in the US. Shares of the company were trading

Zydus Lifesciences gets final FDA nod for Darunavir for HIV-1 treatment

According to market research firm IQVIA, Darunavir Tablets, 75 mg, 150 mg, 600 mg, and 800 mg had annual sales of $275 million in the US

Zydus, Daewoong collaborate to co-develop, market Leuprolide Acetate

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

Zydus Lifesciences receives USFDA approval for Ivabradine tablets

On Friday, shares of Zydus Lifesciences were up/down by 0.34 per cent, ending the day's trade at Rs 640 apiece on the BSE