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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.
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.
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.
Securities in F&O Ban:
Sammaan Capital and Steel Authority of India shares are banned from F&O trading on 20 February 2026.
Stocks to Watch:
ABB India reported an 18.19% decline in consolidated net profit to 432.27 crore in Q4 CY25 compared to Rs 528.41 crore posted in same quarter last year. However, revenue from operations rose 5.7% YoY to Rs 3,557.01 crore reported in the quarter ended 31 December 2025.
CIE Automotive India reported a 10.44% rise in consolidated net profit to 204.30 crore in Q4 CY25 compared to Rs 184.98 crore posted in same quarter last year. However, revenue from operations rose 13.41% YoY to Rs 2,392.99 crore reported in the quarter ended 31 December 2025.
RailTel Corporation of India has announced that it has secured a Rs 36 crore railway signalling project from the Deputy Chief Signal and Telecommunication Engineer.
Texmaco Rail & Engineering has announced that it has executed a Strategic Joint Venture Shareholders’ Agreement with RVNL to build a rolling stock powerhouse and expand its rail EPC footprint.
GHV Infra Projects has announced that it has secured a Rs 123 crore work order from Enmas EPC Power Projects for the supply of rooftop solar plants.
IIFL Finance has announced that its board will meet on February 24 to consider raising up to Rs 10,000 crore through non-convertible debentures (NCDs).
5paisa Capital has announced that its board will meet on February 24 to consider a fund-raising proposal.
Avenue Supermarts has announced that it has opened a new store in Rangareddy, Telangana, bringing its total store count to 449.
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.
Sammaan Capital and Steel Authority of India shares are banned from F&O trading on 19 February 2026.
B. L. Kashyap and Sons announced that it has secured a Rs 300 crore order from CRC Greens for the construction of civil works.
Pace Digitek announced that its material subsidiary, Lineage Power, has secured a $1.35 million order from Yaqin Chem for the supply of mobile battery systems.
DCX Systems announced that it and its wholly owned subsidiary, Raneal Advanced Systems, has secured combined orders worth Rs 45.4 crore for the supply of cable assemblies and printed circuit assemblies.
Bharat Electronics (BEL) announced that its board will meet on February 27 to consider the declaration of an interim dividend for the financial year 2025–26.
Nucleus Software Exports announced that it has expanded its global footprint by incorporating a new arm in Vietnam.
Zydus Lifesciences announced that it has received USFDA approval for Bosentan tablets, used in the treatment of pulmonary arterial hypertension.
Zydus Lifesciences announced the launch of Anyra™, India's first indigenously developed biosimilar of Aflibercept 2 mg. Zydus has also signed an agreement with Regeneron Pharmaceuticals, Inc. and Bayer.
Anyra™ is indicated for the treatment of neovascular (wet) Age-related Macular Degeneration (AMD), visual impairment due to macular edema secondary to Retinal Vein Occlusion (Branch RVO or Central RVO), visual impairment due to Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and visual impairment due to Myopic Choroidal Neovascularization (mCNV).
With this launch, Zydus reinforces its commitment to advancing ophthalmic care and expanding access to high-quality, affordable biologics for patients across India.
Speaking on the launch, Dr. Sharvil P. Patel, Managing Director, Zydus Lifesciences, said, “At Zydus, we are committed to making advanced biologics accessible to patients who need them most. ANYRA™ is a transformative step for affordable retinal care in India. By delivering a high-quality, indigenously developed Aflibercept 2 mg, we are expanding patient access to critical therapies with advanced biologics. Our focus remains on enabling patient-centric outcomes by leveraging science, health and innovation.”
Anyra is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to macular edema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME), diabetic retinopathy (DR), and visual impairment due to myopic choroidal neovascularisation (mCNV). With this launch, Zydus reinforces its commitment to advancing ophthalmic care and expanding access to high-quality, affordable biologics for patients across India.
Presently, more than 100 million people in India are living with diabetes, making it one of the largest diabetic populations globally. Diabetic Retinopathy (DR) affects an estimated 7–8 million individuals, with many progressing to vision-threatening stages such as DME. Wet AMD impacts approximately 1.5– 2 million elderly patients, while retinal vein occlusions affect over 2 million individuals. Collectively, these conditions represent a large patient pool requiring timely anti-VEGF therapy to prevent irreversible vision loss. As chronic retinal diseases require repeated intravitreal injections over extended periods, affordability and continuity of treatment are of concern. Enhanced access to such therapies improves treatment adherence, reduces preventable blindness, and lowers long-term disease burden.
Dr. Sharvil P. Patel, Managing Director, Zydus Lifesciences, said, “At Zydus, we are committed to making advanced biologics accessible to patients who need them most. ANYRA™ is a transformative step for affordable retinal care in India. By delivering a high-quality, indigenously developed Aflibercept 2 mg, we are expanding patient access to critical therapies with advanced biologics. Our focus remains on enabling patient-centric outcomes by leveraging science, health and innovation.”
Separately, the company received final approval from the United States Food and Drug Administration (USFDA) for Bosentan tablets for oral suspension, 32 mg (USRLD: Tracleer Tablets for Oral Suspension, 32 mg). The drug is indicated for the treatment of pulmonary arterial hypertension (PAH), specifically to improve exercise ability and reduce clinical worsening in children (aged 3 years and older) with idiopathic or congenital PAH. It is a dual endothelin receptor antagonist that lowers high blood pressure in the lungs, typically administered based on body weight.
The product will be manufactured at the group’s formulation facility at SEZ, Ahmedabad. According to IQVIA MAT December 2025 data, Bosentan 32 mg tablets recorded annual sales of $9.3 million in the United States. The group now holds 432 approvals and has filed 505 ANDAs since the commencement of its filing process in FY2003–04.
Shares of Zydus Lifesciences rose 0.48% to Rs 914.45 on the BSE.
Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for Bosentan tablets, oral suspension, 32 mg (USRLD: Tracleer® Tablets for Oral Suspension, 32 mg).
Bosentan 32 mg tablets for oral suspension are indicated for the treatment of Pulmonary Arterial Hypertension (PAH), specifically to improve exercise ability and reduce clinical worsening in children (aged 3 years and older) with idiopathic or congenital PAH. It is a dual endothelin receptor antagonist that lowers high blood pressure in the lungs, typically administered based on body weight.
Bosentan 32 mg tablets will be manufactured at the group's formulation manufacturing facility at SEZ, Ahmedabad.
Bosentan 32 mg tablets had annual sales of USD 9.3 mn in the United States (IQVIA MAT December 2025).
Zydus Lifesciences launched PEPAIR™, India's first affordable Oscillating Positive Expiratory Pressure (OPEP) device featuring a 3-resistance system designed to help clear congestion and support effective mucous clearance and improve breathing in patients with COPD, Asthma, and Bronchiectasis.
PEPAIR™ is an innovative, drug-free, handheld device with patented design. More than 90 lakh patients suffer from these chronic respiratory conditions in India. Chronic mucous hypersecretion is a common problem amongst these patients that requires an airway clearance solution for everyday care. PEPAIR™ is being launched in agreement with AeroDel Technology Innovations, an Indian medical device company focused on simplifying inhalation through drug-delivery, pulmonary rehabilitation. In a patient-centric approach, Zydus offers PEPAIR™ at an affordable cost of Rs. 990 per unit.
Speaking on the launch, Dr. Sharvil Patel, Managing Director, Zydus Lifesciences, said, “At Zydus, patient-centric innovation is about advancing healthcare in ways that make everyday care more accessible for patients. With PEPAIR™, India's first affordable OPEP device, we are introducing a drug free, handheld solution designed to support better breathing for patients with COPD, asthma and bronchiectasis. We look forward to expanding our efforts in advancing respiratory health through this launch”