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Zydus Lifesciences announced the receipt of final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ascorbic Acid Injection USP, 25,000 mg/50 mL (500 mg/mL), 5,000 mg/10 mL (500 mg/mL).
The product is primarily used for the short-term treatment of scurvy in adult and paediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated.
Zydus' Ascorbic Acid Injection is the generic equivalent of the reference listed drug (RLD), Ascor® Injection, 25,000 mg/50 mL (500 mg/mL). The USFDA has designated the ANDA for the product as a Competitive Generic Therapy (CGT). Eligibility for the 180-day exclusivity available to certain competitive generic therapies is determined by the USFDA and, where applicable, the period runs from the date of first day of commercial marketing of the product.
The product will be manufactured at the group's USFDA-approved injectable manufacturing plant at Jarod, near Vadodara in Gujarat, and will be marketed in the US market by Zydus Pharmaceuticals (USA) Inc.
The brand product had annual sales of approximately USD 11.6 mn in the United States. (IQVIA MAT June-2026).
Zydus Lifesciences Ltd is down for a fifth straight session today. The stock is quoting at Rs 1106.5, down 0.82% on the day as on 13:19 IST on the NSE. The benchmark NIFTY is down around 0.46% on the day, quoting at 24043.1. The Sensex is at 76859.21, down 0.49%.Zydus Lifesciences Ltd has lost around 3.7% in last one month.Meanwhile, Nifty Pharma index of which Zydus Lifesciences Ltd is a constituent, has increased around 0.84% in last one month and is currently quoting at 26361.9, down 0.53% on the day. The volume in the stock stood at 9.53 lakh shares today, compared to the daily average of 14.79 lakh shares in last one month.
The benchmark August futures contract for the stock is quoting at Rs 1110.1, down 0.87% on the day. Zydus Lifesciences Ltd jumped 12.53% in last one year as compared to a 4.02% slide in NIFTY and a 19.36% spurt in the Nifty Pharma index.
The PE of the stock is 30.57 based on TTM earnings ending June 26.
CIE Automotive India Ltd, Zydus Lifesciences Ltd, Chennai Petroleum Corporation Ltd, Amara Raja Energy & Mobility Ltd are among the other stocks to see a surge in volumes on NSE today, 11 August 2026.
Gland Pharma Ltd clocked volume of 76.21 lakh shares by 14:14 IST on NSE, a 13.82 times surge over two-week average daily volume of 5.52 lakh shares. The stock gained 8.01% to Rs.2,881.00. Volumes stood at 7.21 lakh shares in the last session.
CIE Automotive India Ltd registered volume of 30.04 lakh shares by 14:14 IST on NSE, a 9.29 fold spurt over two-week average daily volume of 3.23 lakh shares. The stock rose 0.02% to Rs.409.60. Volumes stood at 2.36 lakh shares in the last session.
Zydus Lifesciences Ltd recorded volume of 57.93 lakh shares by 14:14 IST on NSE, a 6.23 times surge over two-week average daily volume of 9.30 lakh shares. The stock gained 4.59% to Rs.1,170.40. Volumes stood at 9.32 lakh shares in the last session.
Chennai Petroleum Corporation Ltd saw volume of 108.89 lakh shares by 14:14 IST on NSE, a 6.18 fold spurt over two-week average daily volume of 17.61 lakh shares. The stock increased 14.22% to Rs.1,416.50. Volumes stood at 7.83 lakh shares in the last session.
Amara Raja Energy & Mobility Ltd witnessed volume of 70.1 lakh shares by 14:14 IST on NSE, a 6.17 times surge over two-week average daily volume of 11.36 lakh shares. The stock increased 7.98% to Rs.969.35. Volumes stood at 15.67 lakh shares in the last session.
Zydus Lifesciences Ltd gained for a third straight session today. The stock is quoting at Rs 1159, up 3.57% on the day as on 12:49 IST on the NSE. The benchmark NIFTY is down around 0.51% on the day, quoting at 24458.4. The Sensex is at 78163.16, down 0.48%. Zydus Lifesciences Ltd has gained around 2.45% in last one month.
Meanwhile, Nifty Pharma index of which Zydus Lifesciences Ltd is a constituent, has gained around 3.63% in last one month and is currently quoting at 26479.55, up 0.36% on the day. The volume in the stock stood at 17.56 lakh shares today, compared to the daily average of 10.25 lakh shares in last one month.
The benchmark August futures contract for the stock is quoting at Rs 1160, up 3.69% on the day. Zydus Lifesciences Ltd is up 21.28% in last one year as compared to a 0.12% slide in NIFTY and a 22.17% slide in the Nifty Pharma index.
The PE of the stock is 30.29 based on TTM earnings ending March 26.
Zydus Lifesciences has launched REVAHALE™ (Revefenacin), India's first once-daily nebulised Long-Acting Muscarinic Antagonist (LAMA) indicated for the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD).
REVAHALE is the first and only LAMA available in India that combines once-daily dosing with nebulized administration, offering a new treatment option for COPD patients who require nebulised therapy. Designed to provide sustained 24-hour bronchodilation with a single daily dose, REVAHALE addresses important challenges associated with inhaler-dependent therapies, particularly among elderly patients and those with severe respiratory impairment.
COPD remains a significant public health challenge in India and is a leading cause of morbidity and mortality. While inhaled bronchodilator therapies have transformed disease management, many patients continue to experience difficulties using handheld inhalers, cognitive limitations, severe breathlessness, or an inability to generate sufficient inspiratory effort for effective drug delivery.
REVAHALE has been developed to address these unmet needs through a convenient nebulised delivery platform that reduces dependence on inhalation technique and inspiratory flow. The therapy is compatible with standard jet nebulisers, providing flexibility and ease of use for patients and caregivers.
The company said the therapy is designed to provide sustained 24-hour bronchodilation through a single daily dose. It is intended to address challenges associated with inhaler-based therapies, particularly among elderly patients and those with severe respiratory impairment.
COPD is a major public health challenge in India and a leading cause of morbidity and mortality. According to the company, some patients face difficulties using handheld inhalers due to cognitive limitations, severe breathlessness or an inability to generate sufficient inspiratory effort for effective drug delivery.
REVAHALE uses a nebulised delivery platform that reduces dependence on inhalation technique and inspiratory flow. The therapy is compatible with standard jet nebulisers, providing flexibility and ease of use for patients and caregivers.
Zydus said clinical studies of revefenacin have demonstrated significant and sustained improvements in lung function among patients with moderate to very severe COPD, while maintaining a favourable safety profile. The drug is designed to provide sustained bronchodilation over 24 hours through once-daily administration.
Zydus Lifesciences is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.
The company’s consolidated net profit jumped 8.68% to Rs 1,272.5 crore on 16.22% increase in revenue from operations to Rs 7,587 crore in Q4 FY26 over Q4 FY25.
The counter rose 0.49% to Rs 1,120.70 on the BSE.
Indocyanine Green for Injection is an optical imaging agent used for fluorescence imaging of blood vessels, blood flow and tissue perfusion during vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including minimally invasive procedures. It is also indicated for fluorescence imaging of extrahepatic biliary ducts, lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer, as well as ophthalmic angiography. The product is approved for use in adults and, for certain indications, in paediatric patients aged one month and older.
The product will be manufactured at the group's USFDA-approved injectable manufacturing facility at Jarod, near Vadodara, Gujarat, and marketed in the United States through Zydus Pharmaceuticals (USA) Inc.
Speaking on the development, Dr Sharvil Patel, Managing Director, Zydus Lifesciences, said, “Indocyanine green sits at the intersection of medicine and imaging science, requiring precise control of chromophore purity, photostability and lyophilisation. Developing and securing approval for such a complex product with our partner reflects the capabilities we have built and our shared commitment to high standards. It also advances our goal of making essential medicines and diagnostics more accessible, while strengthening our presence in the functional dye and imaging agent segment, where we continue to invest.”
The approval further expands Zydus' portfolio of complex injectable and imaging products. The company said the product will be supplied as a kit containing single-patient-use vials of Indocyanine Green for Injection, 25 mg, along with single-dose vials of Sterile Water for Injection, 10 ml.
According to IQVIA MAT June 2026 data, the reference product recorded annual sales of approximately $125.8 million in the United States, with volumes of 0.64 million units.
As of 30 June 2026, the group had received 445 USFDA approvals and filed 513 ANDAs.
The counter rose 0.20% to Rs 1,118.50 on the BSE.
Zydus Lifesciences (Zydus) announces the receipt of final approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Indocyanine Green for Injection, USP, 25 mg/vial, a sterile lyophilised powder for reconstitution.
Zydus' Indocyanine Green for Injection is the generic equivalent of the reference listed drug (RLD), IC-Green® by Diagnostic Green LLC. The USFDA has designated the application a Competitive Generic Therapy (CGT). Eligibility for the 180-day exclusivity available to certain competitive generic therapies is determined by the USFDA and, where it applies, the period runs from the date of first commercial marketing.
Indocyanine Green for Injection is an optical imaging agent indicated for fluorescence imaging of vessels, blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures; fluorescence imaging of extrahepatic biliary ducts; fluorescence imaging of lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer; and ophthalmic angiography. The product is indicated in adults and, for certain indications, in paediatric patients aged 1 month and older.
Zydus Lifesciences Ltd dropped for a fifth straight session today. The stock is quoting at Rs 1106.7, down 0.18% on the day as on 13:19 IST on the NSE. The benchmark NIFTY is up around 0.86% on the day, quoting at 23972.3. The Sensex is at 76761.63, up 0.92%.Zydus Lifesciences Ltd has lost around 1.3% in last one month.Meanwhile, Nifty Pharma index of which Zydus Lifesciences Ltd is a constituent, has increased around 2.83% in last one month and is currently quoting at 25548.15, up 1.54% on the day. The volume in the stock stood at 3.8 lakh shares today, compared to the daily average of 13.4 lakh shares in last one month.
The benchmark July futures contract for the stock is quoting at Rs 1108.1, down 0.12% on the day. Zydus Lifesciences Ltd jumped 12.92% in last one year as compared to a 2.87% slide in NIFTY and a 13.98% spurt in the Nifty Pharma index.
The PE of the stock is 29.97 based on TTM earnings ending March 26.