Ahmedabad, India / Pennington, New Jersey, August 4, 2026
Zydus Lifesciences Limited has received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Indocyanine Green for Injection, USP, 25 mg/vial. The product is the generic equivalent of IC-Green® and has been designated by the FDA as a Competitive Generic Therapy (CGT), making it eligible for 180 days of CGT exclusivity beginning from the date of first commercial marketing. The approval represents another milestone in Zydus’ strategy to expand its complex injectable portfolio in the United States while strengthening its position in the specialized functional dye and medical imaging segment. The company plans to launch the product shortly, allowing it to capitalize on the exclusivity period in a market where the reference product generated approximately US$125.8 million in annual sales for the twelve months ending June 2026.
Imaging Agent Supports Multiple Surgical and Diagnostic Applications
Indocyanine Green for Injection is an optical imaging agent used to provide real-time fluorescence imaging during a wide range of surgical and diagnostic procedures. It enables visualization of blood vessels, tissue perfusion, blood flow, lymphatic vessels, lymph nodes, extrahepatic biliary ducts, and supports ophthalmic angiography. The product is indicated for use before, during, and after vascular, gastrointestinal, organ transplant, plastic, microvascular, reconstructive, and minimally invasive surgeries, as well as lymphatic mapping in adults with cervical and uterine cancers. It is approved for adults and selected pediatric patients aged one month and older for certain indications. Zydus will manufacture the product at its USFDA-approved injectable manufacturing facility in Jarod, Gujarat, with commercialization in the United States handled by Zydus Pharmaceuticals (USA) Inc. The product will be supplied as a kit containing a single-use vial of sterile lyophilized Indocyanine Green powder along with a single-dose vial of Sterile Water for Injection for reconstitution.
Approval Highlights Zydus’ Expertise in Complex Injectable Development
According to Dr. Sharvil Patel, Managing Director of Zydus Lifesciences, the development of Indocyanine Green required advanced expertise in chromophore purity, photostability, and lyophilization technology, reflecting the company’s growing capabilities in developing technically challenging pharmaceutical products. He noted that the approval aligns with Zydus’ broader mission of improving access to essential medicines and diagnostic products while expanding its footprint in the functional dye and imaging agent market. The company emphasized that the product was developed through a model combining in-house formulation and analytical expertise with external collaboration tailored for specialized programs. The approval also expands Zydus’ portfolio of complex injectables, reinforcing investments in innovative pharmaceutical technologies designed for highly regulated markets.
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U.S. Approval Reinforces Global Growth Strategy
The latest approval further strengthens Zydus Lifesciences’ growing U.S. regulatory portfolio, bringing the company’s cumulative total to 445 USFDA approvals and 513 ANDA filings as of June 30, 2026. With the planned commercial launch expected to activate the 180-day Competitive Generic Therapy exclusivity, Zydus is positioned to gain an early advantage in the U.S. market while enhancing availability of an important imaging agent used across numerous medical specialties. The approval underscores the company’s continued investment in complex generic medicines, sterile injectables, and advanced imaging products, supporting its long-term strategy of delivering high-quality, affordable healthcare solutions while expanding its presence in specialized pharmaceutical segments worldwide.
Source: Zydus, Zydus Lifesciences press release
