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Zydus Lifesciences Ltd gained for a fifth straight session today. The stock is quoting at Rs 907, up 1.73% on the day as on 12:39 IST on the NSE. The benchmark NIFTY is down around 0.59% on the day, quoting at 23855.35. The Sensex is at 76913.19, down 0.84%. Zydus Lifesciences Ltd has slipped around 1.74% in last one month.
Meanwhile, Nifty Pharma index of which Zydus Lifesciences Ltd is a constituent, has slipped around 4.54% in last one month and is currently quoting at 21991.2, up 0.94% on the day. The volume in the stock stood at 3.71 lakh shares today, compared to the daily average of 6.62 lakh shares in last one month.
The benchmark April futures contract for the stock is quoting at Rs 908, up 1.63% on the day. Zydus Lifesciences Ltd is up 4.39% in last one year as compared to a 4.5% spurt in NIFTY and a 8.48% spurt in the Nifty Pharma index.
The PE of the stock is 19.1 based on TTM earnings ending December 25.
Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Dapagliflozin Tablets, 5 mg and 10 mg (USRLD: Farxiga® Tablets, 5 mg and 10 mg).
Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. With this approval, Zydus is eligible for 180 days of shared generic drug exclusivity for Dapagliflozin Tablets, 5 mg and 10 mg.
Dapagliflozin tablets will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad.
Dapagliflozin tablets had annual sales of USD 10.2bn in the United States (IQVIA MAT February 2026).
According to IQVIA MAT February 2026 data, Dapagliflozin tablets had annual sales of $10.2 billion in the United States. With this approval, Zydus is eligible for 180 days of shared generic drug exclusivity. The group now has 436 USFDA approvals and has filed 505 ANDAs since it began filing in FY2003-04.
Zydus Lifesciences operates as an integrated pharmaceutical company across research, development, production, marketing, and distribution of pharmaceutical products.
The company’s consolidated net profit rose 7.7% to Rs 1,102.64 crore on a 32.3% increase in revenue from operations to Rs 6,780.40 crore in Q3 FY26 over Q3 FY25.
Dapsone Tablets USP, 25 mg and 100 mg are indicated for the treatment of leprosy and dermatitis herpetiformis. The tablets will be manufactured at the group’s formulation facility at SEZ-II, Ahmedabad, and distributed by Viona Pharmaceuticals Inc. The product reported annual sales of USD 8.4 million in the United States (IQVIA MAT December 2025).
With this approval, the group now has 434 USFDA approvals and has filed 505 ANDAs since the commencement of filings in FY2003-04.
Zydus Life Sciences operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing, and distribution of pharmaceutical products.
Shares of Zydus Lifesciences fell 2.09% to Rs 903.20 on the BSE.
Zydus Lifesciences has received final approvals from the United States Food and Drug Administration (USFDA) for Ivermectin Tablets USP, 3 mg (USRLD: Stromectol® Tablets, 3 mg) and Dapsone Tablets USP, 25 mg and 100 mg (USRLD: Dapsone Tablets USP, 25 mg and 100 mg).
Ivermectin Tablets USP, 3 mg, are prescription anti-parasitic medications primarily indicated for treating parasitic worm infections in humans, specifically intestinal strongyloidiasis and onchocerciasis. Ivermectin tablets will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad and distributed by Viona Pharmaceuticals Inc. Ivermectin Tablets USP, 3 mg had annual sales of USD 14.8 mn
Dapsone Tablets USP, 25 mg and 100 mg are indicated for the treatment of leprosy (all forms, including multibacillary and paucibacillary) and dermatitis herpetiformis. It acts as an anti-infective and antibacterial agent and is used to control skin lesions in dermatitis herpetiformis and for leprosy. Dapsone tablets will be manufactured at the group's formulation manufacturing facility at SEZ-II, Ahmedabad and distributed by Viona Pharmaceuticals Inc. Dapsone Tablets USP, 25 mg and 100 mg had annual sales of USD 8.4 mn in the United States (IQVIA MAT December 2025).
Zydus Lifesciences announced that the pivotal Dahlia pharmacokinetic study (PK study) has successfully met its primary study objective. The randomized, double-blind, multi-centre clinical PK study demonstrated pharmacokinetic equivalence (bioequivalence) of FYB206 (pembrolizumab) with the oncology blockbuster drug Keytruda®. Zydus has in-licensed FYB206, a proposed biosimilar to immuno-oncology therapy Keytruda® (pembrolizumab), exclusively from Formycon AG for the U.S. and Canadian markets.
'The positive clinical data for the FYB206 marks a key milestone in our collaboration with Formycon and reflects our shared commitment to expand access to affordable, life-saving oncology treatments.' stated Dr. Sharvil P. Patel, Managing Director of Zydus Lifesciences Limited. 'FYB206 represents the absolute cornerstone of our strategic entry into the complex North American immuno-oncology market.'
At the beginning of 2025, Formycon and the US Food and Drug Administration (FDA) had agreed on a streamlined clinical strategy that aims to sufficiently demonstrate the therapeutic comparability of FYB206 with the reference drug Keytruda®, based on comprehensive analytical data and data from the Dahlia PK study. Having achieved the primary study objective, Formycon is now focusing on completing all development activities to finalize the documents for regulatory approval. The company is working closely with the regulatory authorities to make FYB206 available as soon as possible after the exclusivity of the reference drug expires.
With the clinical data package effectively complete, this achievement clears the pathway for a near-term Biologics License Application (BLA) filing with the USFDA. This positions Zydus as a potential first wave filer and a new entrant in the North American immuno-oncology biosimilar market.
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Zydus Lifesciences has announced that the US FDA has completed an inspection of the company’s Ahmedabad unit with “nil” observations.
The inspection was carried out at the company’s Unit 9 facility at Zydus Biotech Park in Changodar, Ahmedabad, from 16 February to 19 February, 2026, the drug maker said in a regulatory filing.
The company added that the inspection concluded without any observations, indicating compliance with the regulator’s standards.
Zydus Lifesciences operates as an integrated pharmaceutical company with business encompassing the entire value chain in the research, development, production, marketing and distribution of pharmaceutical products.
The company’s consolidated net profit rose 7.7% to Rs 1,102.64 crore on 32.3% increase in revenue from operations to Rs 6,780.40 crore in Q3 FY26 over Q3 FY25.
Shares of Zydus Lifesciences rose 0.08% to Rs 903 on the BSE.