Zydus Lifesciences has received final approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application for Indocyanine Green for Injection, a sterile lyophilised powder for reconstitution. According to company reports, the approved product is the generic equivalent of IC-Green, marketed by Diagnostic Green LLC. The USFDA has designated the application a Competitive Generic Therapy (CGT), making the company eligible for 180-day marketing exclusivity where applicable, with eligibility determined by the USFDA and commencing from the date of first commercial launch. 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. As per Business Standard, the company plans to launch the product in the US market shortly, triggering the 180-day CGT exclusivity period.
The company has secured two projects worth nearly ₹900 crore in July, marking significant business expansion. Additionally, the company's subsidiary, Sunset Spaces, has entered into a Joint Development Agreement (JDA) for a cluster redevelopment project in Sewri, Mumbai. The project involves the development of a high-rise residential tower with high-street retail spaces and has an estimated gross development value (GDV) of approximately ₹450 crore for the company. This development represents a strategic expansion into the Mumbai real estate market.
In the latest trading session, Zydus Lifesciences shares ended marginally higher by 0.80% at ₹1,130.00 on the NSE on Tuesday, August 4, following the USFDA approval announcement. The stock has demonstrated strong performance, with the company's consolidated net profit jumping 8.68% to ₹1,272.5 crore on a 16.22% increase in revenue from operations to ₹7,587 crore in Q4 FY26 over Q4 FY25. As of June 30, 2026, the group had received 445 USFDA approvals and filed 513 ANDAs, positioning the company well for continued growth in the US market. The company's market capitalisation stands at ₹113,352.26 crore.
Indocyanine Green for Injection is an optical imaging agent used for fluorescence imaging of blood vessels, blood flow and tissue perfusion during various surgical procedures including vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries. 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. The approved 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 for reconstitution. The drug is approved for use in adults and, for certain indications, in paediatric patients aged one month and older. Dr Sharvil Patel, Managing Director of Zydus Lifesciences, noted that the approval advances the company's goal of making essential medicines and diagnostics more accessible while strengthening presence in the functional dye and imaging agent segment.
