Zydus Lifesciences Limited has received 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.

The approved product is the generic equivalent of IC-Green by Diagnostic Green LLC. The USFDA has also designated the application as a Competitive Generic Therapy (CGT).

Eligibility for the 180-day exclusivity granted to certain CGT products is determined by the USFDA and, where applicable, begins 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 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 for 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 Zydus' USFDA-approved injectable manufacturing facility at Jarod near Vadodara, Gujarat, and marketed in the United States through Zydus Pharmaceuticals (USA) Inc.

Speaking on the approval, Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Limited, 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.”

According to IQVIA MAT June 2026 data, the reference product recorded annual sales of approximately USD 125.8 million in the United States, representing 61% year-on-year growth, with sales volumes of 0.64 million units, up 27.1%.

With this approval, the Zydus Group now has 445 USFDA approvals and has filed 513 ANDAs as of June 30, 2026.