Zydus Lifesciences Ltd

Zydus Lifesciences has received the Establishment Inspection Report (EIR) report from the US FDA for the inspection conducted at its API manufacturing facility located at Ankleshwar. This facility underwent an inspection from 10th to 14th March 2025, and the inspection has been classified as No Action Indicated (NAI). The USFDA has concluded that this inspection is 'closed'. Powered by Capital Market - Live

The inspection was conducted by the USFDA from March 10 to March 14, 2025. Following the review, the inspection has been classified as no action indicated (NAI). The USFDA has concluded that the inspection is now closed. Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The company's consolidated net profit shed 0.96% to Rs 1,170.9 crore on a 17.21% rise in revenue from operations to Rs 6,290.2 crore in Q4 FY25 over Q4 FY24. Shares of Zydus Lifesciences shed 0.36% to Rs 975.20 on the BSE. Powered by Capital Market - Live

The facility underwent an inspection from April 21 to April 25, 2025. The inspection has been classified as Voluntary Action Indicated (VAI), with the FDA confirming the inspection as closed. The company's consolidated net profit shed 0.96% to Rs 1,170.9 crore on 17.21% rise in revenue from operations to Rs 6290.2 crore in Q4 FY25 over Q4 FY24. Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Shares of Zydus Lifesciences rose 0.71% to Rs 980 on the BSE. Powered by Capital Market - Live

  Zydus Lifesciences has received the EIR report from the USFDA for the inspection conducted at its API manufacturing facility located at Dabhasa near Vadodara. This facility underwent an inspection from 21st to 25th April 2025 and has been classified as Voluntary Action Indicated (VAI). FDA confirmed the inspection as 'closed'.  Powered by Capital Market - Live

Zydus Lifesciences Ltd is up for a fifth straight session today. The stock is quoting at Rs 976, up 0.24% on the day as on 12:44 IST on the NSE. The benchmark NIFTY is up around 0.13% on the day, quoting at 25136.5. The Sensex is at 82493.19, up 0.06%. Zydus Lifesciences Ltd has gained around 10.3% in last one month. Meanwhile, Nifty Pharma index of which Zydus Lifesciences Ltd is a constituent, has gained around 3.79% in last one month and is currently quoting at 21826.8, up 0.35% on the day. The volume in the stock stood at 4.89 lakh shares today, compared to the daily average of 11.15 lakh shares in last one month. The benchmark June futures contract for the stock is quoting at Rs 983.3, up 0.79% on the day. Zydus Lifesciences Ltd is down 10.03% in last one year as compared to a 8.04% jump in NIFTY and a 11.24% jump in the Nifty Pharma index.The PE of the stock is 16.96 based on TTM earnings ending March 25.Powered by Capital Market - Live

Rifaximin tablets are indicated for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults. The tablets will be produced at the Group's manufacturing facility at SEZ II, Ahmedabad. According to IQVIA MAT 2025, Rifaximin tablets had annual sales of USD $2,672.9 million in the United States. The group now has 427 approvals and has filed 492 Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process in FY 2003-04. The company's consolidated net profit shed 0.96% to Rs 1,170.9 crore on 17.21% rise in revenue from operations to Rs 6290.2 crore in Q4 FY25 over Q4 FY24. Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. Shares of Zydus Lifesciences shed 0.53% to Rs 924.95 on the BSE. Powered by Capital Market - Live

Zydus Lifesciences has received tentative approval from the United States Food and Drug Administration (USFDA) for Rifaximin Tablets, 550 mg (USRLD: Xifaxan' Tablets, 550 mg). Rifaximin tablets are indicated for the treatment of irritable bowel syndrome with diarrhoea (IBS-D) in adults. Rifaximin tablets will be produced at the Group's manufacturing site at SEZ II, Ahmedabad. Rifaximin tablets had annual sales of USD $2672.9 mn in the United States (IQVIA MAT March 2025).Powered by Capital Market - Live

The fast track designation is designed to facilitate the development and expedite the review of drugs that treat serious conditions and address unmet medical needs. Drugs granted this designation are eligible for benefits such as accelerated approval, priority review, and more frequent interactions with the USFDA during the drug development process. The company stated that people living with ALS have an average survival of approximately two to five years from diagnosis, with most ALS patients dying from respiratory failure. ALS patients experience neuroinflammation and rapid neurodegeneration. Axonal neurodegeneration leads to the formation of neurofilaments, which first accumulate in the cerebrospinal fluid (CSF) of ALS patients and then slowly enter the bloodstream. Due to rapid neurodegeneration, steady loss of the ability to move, speak, eat, and eventually breathe, paralysis and death are common outcomes in ALS patients. ALS affects approximately 32,000 people in the U.S., with an average of 5,000 new patients diagnosed every year, according to statistics from the Centers for Disease Control and Prevention (CDC). More than 30,000 people are estimated to be living with ALS in Europe (European Union and United Kingdom), while India has an estimated 75,000 people living with ALS. Usnoflast, a novel chemical entity (NCE), had earlier received Orphan Drug Designation (ODD) from the USFDA, which offers development incentives including tax credits for clinical testing, waiver of certain FDA fees, and a potential seven-year marketing exclusivity upon USFDA approval. Usnoflast (ZYIL1) is a novel oral small molecule NLRP3 inhibitor studied in preclinical models of neuroinflammation, Parkinson's disease, inflammatory bowel disease (IBD), and multiple sclerosis (MS). Zydus has completed a Phase 2(a) randomized, double-blind, placebo-controlled trial in 24 ALS patients across seven sites in India and recently received USFDA approval to initiate a Phase 2(b) randomized, double-blind, placebo-controlled trial in ALS patients. Chairman of Zydus Lifesciences Limited, Pankaj Patel, said, 'This 'Fast Track Designation' in addition to the previous 'Orphan Drug Designation' granted by the USFDA, underlines the urgent need to develop treatments to address Amyotrophic Lateral Sclerosis (ALS), which is a fatal neurodegenerative disease. Zydus is committed to unlocking new frontiers in neuroscience and develop Usnoflast for patients with ALS.' Zydus Lifesciences is a discovery-driven, global life sciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The company reported a 29.62% jump in consolidated net profit of Rs 1,023.5 crore in Q3 FY25 compared with Rs 789.6 crore in Q3 FY24. Revenue from operations increased 16.96% YoY to Rs 5,269.1 crore during the quarter. Powered by Capital Market - Live

The approved drug is the generic equivalent of the reference listed drug Absorica capsules, available in 10 mg, 20 mg, 25 mg, 30 mg, 35 mg, and 40 mg strengths. Isotretinoin capsules are indicated to treat severe, disfiguring nodular acne. The product will be manufactured at the Group's facility in Moraiya, Ahmedabad. According to IQVIA MAT 2025, Isotretinoin capsules had annual sales of $115.4 million in the United States. As of 31st March 2025, the group now has received a total of 427 approvals and has so far filed 492 ANDAs since the commencement of the filing process in FY 2003-04. Zydus Lifesciences is a global life sciences company engaged in the discovery, development, manufacturing, and marketing of a wide range of healthcare therapies. The company's consolidated net profit fell 1% to Rs 1,170.90 crore despite of 17.2% increase in net sales to Rs 6290.20 crore in Q4 FY25 over Q4 FY24. The counter rose 0.45% to settle at Rs 908 on Friday, 23 May 2025.Powered by Capital Market - Live

Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) Isotretinoin capsules USP, 10 mg 20 mg, 25 mg, 30 mg, 35 mg and 40 mg (USRLD: Absorica' Capsules, 10 mg, 20 mg, 25 mg, 30 mg, 35 mg and 40 mg). Powered by Capital Market - Live