Zydus Lifesciences gains on USFDA nod for generic Indocyanine Green injection

Zydus Lifesciences announced that it has received final nod from the United States Food and Drug Administration for its abbreviated new drug application for Indocyanine Green for Injection, a sterile lyophilised powder for reconstitution.

The approved product is the generic equivalent of IC-Green, marketed by Diagnostic Green LLC. The USFDA has designated the application as a Competitive Generic Therapy (CGT). Eligibility for the 180-day marketing exclusivity available under the CGT pathway will be determined by the USFDA and, where applicable, will commence from the date of first commercial launch.

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.

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 0.20% to Rs 1,118.50 on the BSE.

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