Zydus Secures USFDA Final Approval for Indocyanine Green for Injection, Targeting 180-Day CGT Exclusivity
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. The product is a generic equivalent of the reference listed drug (RLD), IC-Green® by Diagnostic Green LLC, and the USFDA designated the application as a Competitive Generic Therapy (CGT).The approval makes Zydus’s product eligible for certain competitive generic therapy exclusivity, which is determined by the USFDA and begins from the date of first commercial marketing.
Indocyanine Green for Injection is an optical imaging agent designed for fluorescence imaging in various medical procedures. Its uses include imaging vessels, blood flow and tissue perfusion before, during, and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, as well as fluorescent imaging of extrahepatic biliary ducts and lymph nodes. The product is indicated for adults and certain indications are available for pediatric patients aged 1 month and older.
The medicine will be manufactured at Zydus’s USFDA approved injectable manufacturing plant located in Jarod, near Vadodara in Gujarat. It will be marketed in the US market by Zydus Pharmaceuticals (USA) Inc. The product is supplied as a kit, containing single-patient-use vials of Indocyanine Green for Injection (25 mg) and single-dose vials of Sterile Water for Injection (10 ml).
Dr. Sharvil Patel, Managing Director at Zydus Lifesciences Limited, commented on the significance of the approval, stating that securing approval for this complex product reflects the capabilities built by the company and its partners. He added that the achievement advances Zydus's commitment to making essential medicines and diagnostics accessible while strengthening its presence in the functional dye and imaging agent segment.
Market Context and Group Portfolio
The brand name had achieved annual sales of approximately USD 125.8 million in the United States, representing a growth of 61.0%. Volume details, according to IQVIA MAT June-2026, stood at 0.64 million units, a volume increase of 27.1%.The approval adds to the group's portfolio of complex injectable and imaging products. As of 30 June 2026, Zydus has secured 445 approvals and had filed 513 ANDAs with the USFDA.
Summary of Market Data (Reference Drug)
| Metric | Details |
|---|---|
| Annual Sales in the U.S. | USD 125.8 million |
| Growth in Sales | 61.0% |
| Volume Units | 0.64 million units |
| Growth in Volume | 27.1% |
The approval signifies the successful implementation of a development model that combines internal formulation and analytical capability with external partnership selection for specific programs, further solidifying Zydus's investment in the functional dye and imaging agent segment.
ZYDUSLIFE Stock Price Movement
At 3:18 PM, Zydus Lifesciences stock sheds 0.57%, trading down by ₹6.40 to settle at ₹1114.6 in live market action. The equity has thus far ranged between a low of ₹1113.1 and a high of ₹1128.6 as traders digest the intraday movement.Disclaimer: Due care and diligence have been taken in compiling and presenting news and market-related content. However, errors or omissions may arise despite such efforts.
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