Zydus Lifesciences said the US Food and Drug Administration (USFDA) has completed an on-site inspection of its pharmacovigilance and post-marketing surveillance systems at the company’s New Jersey office, with nil observations.
The inspection was conducted from September 22 to 25, 2026. The company disclosed the outcome under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
The development comes as Zydus continues to expand its portfolio of generic medicines in the US market.
In August, the company received final USFDA approval for its Abbreviated New Drug Application (ANDA) for Ascorbic Acid Injection USP, available in strengths of 25,000 mg/50 mL (500 mg/mL) and 5,000 mg/10 mL (500 mg/mL).
The injection is indicated for the short-term treatment of scurvy in adult and paediatric patients aged 5 months and older for whom oral administration is not possible, insufficient or contraindicated.
Zydus’ product is the generic equivalent of Ascor Injection, the reference listed drug (RLD). The USFDA has designated the ANDA as a Competitive Generic Therapy (CGT). For certain competitive generic therapies, the USFDA may grant 180-day exclusivity. Where applicable, the exclusivity period begins on the date of first commercial marketing of the product.
The company said that the injection will be manufactured at its USFDA-approved injectable manufacturing facility in Jarod, near Vadodara, Gujarat, and marketed in the US by Zydus Pharmaceuticals (USA) Inc.
Earlier, Zydus received USFDA approval for Indocyanine Green for Injection, USP, 25 mg/vial, a sterile lyophilised powder for reconstitution. The product was also granted 180-day CGT exclusivity.
The injection is the generic equivalent of IC-Green, the reference listed drug marketed by Diagnostic Green LLC.
Indocyanine Green for Injection is an optical imaging agent used for fluorescence imaging of vessels, blood flow and tissue perfusion before, during and after vascular, gastrointestinal, organ transplant, plastic, micro- and reconstructive surgeries, including general minimally invasive surgical procedures.
The product is also indicated for fluorescence imaging of extrahepatic biliary ducts and for imaging lymph nodes and lymphatic vessels during lymphatic mapping in adults with cervical and uterine cancer, and for ophthalmic angiography.
The product is indicated for adults and, for certain indications, paediatric patients aged 1 month and older.
The product will also be manufactured at Zydus’ USFDA-approved injectable manufacturing facility in Jarod, Gujarat, and marketed in the US by Zydus Pharmaceuticals (USA) Inc.
