Page 5 - Zydus Lifesciences

USFDA cites manufacturing lapses at Zydus Lifesciences' Gujarat plant

The US health regulator has pulled up Zydus Lifesciences for manufacturing lapses at its Gujarat-based plant. In a warning letter to company's Managing Director Sharvil Patel, the US Food and Drug Administration (USFDA) noted that the drug maker failed to investigate contamination identified in drug products at its Jarod-based plant in Vadodara district. The USFDA said it inspected the manufacturing facility from April 15 to 23, 2024. "This warning letter summarises significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals," it added. It further said: "Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated." A warning letter is issued when the US health regulator finds that a manufacturer has significantly violated its regulations. Elaborating on the manufacturing issues at the facility, USFDA noted: "Your firm failed to thorough

Zydus Lifesciences gets USFDA nod to mkt Scopolamine transdermal system

Zydus Lifesciences Ltd on Friday said it has received the final approval from the US Health regulator to market its Scopolamine transdermal system indicated to prevent nausea and vomiting under different circumstances. The approval granted by the US Food and Drug Administration (USFDA) is to market the Scopolamine transdermal system of dosage 1 mg/3 days, Zydus Lifesciences said in a regulatory filing. The Scopolamine transdermal system will be produced at the group's transdermal manufacturing site at SEZ, Matoda, Ahmedabad, it added. Scopolamine transdermal System is indicated to prevent nausea and vomiting after anaesthesia, narcotic pain medicines, and surgery. It is also used to prevent nausea and vomiting caused by motion sickness. "This is the fifth abbreviated new drug application (ANDA) approval for Zydus in the transdermal portfolio, leveraging the group's strengths in the manufacturing of complex drug device dosage forms," the company said. Scopolamine Transdermal System

Zydus Lifesciences share price zooms 4% on USFDA nod for Parkinson's drug

Zydus Lifesciences share price soared up to 3.8 per cent at Rs 1156.45 per share on the BSE in Wednesday's intraday deals

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At 6:52 AM, GIFT Nifty Futures fell 10 points, trading at 25,008, indicating a flat to negative start for Indian markets.

Zydus Life shares sink as analysts wary of 'premium' Sterling Biotech buy

Despite the acquisition effort, analysts await details on the joint venture's renewed strategy and planned investments to revitalise SBL's prospects

Zydus Lifesciences to acquire 50% stake in Sterling Biotech

Firm will focus on animal-free protein production

Zydus Lifesciences to have 50% stake in Sterling Biotech from Perfect Day

Zydus Lifesciences on Saturday said it has inked a pact with Perfect Day Inc to acquire 50 per cent stake in Sterling Biotech. As part of the deal, Perfect Day Inc, a Temasek portfolio company, will sell its 50 per cent shareholding in Sterling Biotech for an undisclosed amount. Post the transaction, Sterling Biotech will become a 50:50 joint venture with equal representation on the Board, Zydus Lifesciences said in a statement. Financial details of the deal were not shared. The JV will establish a manufacturing facility to manufacture fermented animal-free protein to cater to the global markets, it added. The acquisition also marks Zydus' foray into specialised biotech products for health and nutrition, specifically catering to consumers who prefer animal-free protein or suffer from lactose intolerance, the Gujarat-based firm said. Perfect Day's precision-fermented protein is found in ice creams, cream cheese, sports nutrition products, and baked goods with high functionality ..

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Analysts wary of Zydus Life's US sales post FY25, valuations; stock down 5%

Shares of Zydus lifesciences slipped 5.3 per cent to Rs 1232.40 per share on the BSE in Monday's early morning trade

Zydus Lifesciences Q1 FY25 results: PAT up 31%, revenue rises 21%

The API business contributed 2 per cent to consolidated revenues, growing 2 per cent Y-o-Y to Rs 141.5 crore

Zydus Lifesciences Q1FY25 results: Net profit rises 31% to Rs 1,420 cr

Zydus Lifesciences on Friday said its consolidated net profit increased 31 per cent year on year to Rs 1,420 crore in the first quarter ended June 2024 on the back of robust sales. The drug maker had reported a net profit of Rs 1,087 crore in the April-June quarter of last fiscal. Revenue from operations rose to Rs 6,207 crore in the period under review as compared to Rs 5,140 crore in the June quarter of FY24, Zydus Lifesciences said in a statement. "Sustained growth momentum across our businesses along with enhanced profitability drove our strong Q1 performance," Zydus Lifesciences Managing Director Sharvil Patel said. Execution success of company's differentiated pipeline in the US and outperformance of India geography business were particularly noteworthy, he added. "We are on course to achieve our growth aspirations for FY25 and are committed to investing in sustainable growth initiatives and innovative solutions for the future," Patel said. The company said its India sales

Zydus Lifesciences hits all time high on USFDA nod for drug worth $2 Bn

Zydus Lifesciences stock surged as much as 2.61 per cent, hitting its all time high at Rs 1,313.05 per share on the BSE in Friday's intraday deals

Zydus Life gains over 2% on securing nod from COFERRIS to market Mamitra

The uptick in the stock price came after the pharmaceutical company announced that it has secured an approval from COFEPRIS of Mexico to market Mamitra to treat various cancers.

Zydus Life stock price jumps 6% on USFDA nod for Valsartan tablets

The shares surged after the pharmaceutical major announced that it has secured final nod from United States Food and Drug Administration (USFDA) for Valsartan tablets.

Gland Pharma, Zydus Lifesciences secure USFDA approvals for key medications

Gland Pharma, a Hyderabad-based generic injectable-focused company, received tentative approval for Latanoprostene Bunod Ophthalmic Solution, 0.024 per cent

Zydus Life Vadodara facility gets OAI report from USFDA, stock falls 3%

The fall in the stock came after the company announced that it has secured an Official Action Indicated (OAI) report from the United States Food and Drug Administration (USFDA).

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At 6:36 AM, GIFT Nifty futures were up 19 points, trading at 24,828.50 levels, indicating a higher start for the day.

USFDA classifies inspection of Zydus unit as 'official action indicated'

Zydus Lifesciences on Thursday said the US health regulator has cautioned that its Gujarat-based injectables plant may be subject to regulatory actions. The company said it has received a report from the US Food and Drug Administration (USFDA) for the inspection conducted at its injectables manufacturing facility located at Jarod, near Vadodara, Gujarat between April 15-23, 2024. The USFDA has determined that the inspection classification of this facility is Official Action Indicated (OAI), it added. According to FDA, OAI means "objectionable conditions were found and regulatory administrative sanctions by FDA are indicated" during the inspection. "The company will work closely with the agency to resolve the regulatory status of this facility expeditiously," the drug maker said. Shares of Zydus Lifesciences settled marginally up at Rs 1,185.30 apiece on the BSE.

Zydus announces licensing deal with Takeda for new GERD drug Vault

Vault works by inhibiting the production of stomach acid and is approved by the Drugs Controller General of India (DCGI) for the treatment of reflux esophagitis and other acid peptic disorders (APDs)

Zydus Lifesciences hits all time high on USFDA nod for multiple drugs

Shares of Zydus Lifesciences zoomed up to 1.93 per cent, hitting its all time high at Rs 1203.20 per share on the BSE in Thursday's intraday trade