Zero USFDA Observations
Zydus Lifesciences Reports USFDA Inspection Concludes With Zero Observations in New Jersey
Anonymous
Zydus Lifesciences said a USFDA inspection of its pharmacovigilance and post-marketing surveillance systems at its New Jersey office concluded with no observations. The onsite inspection ran from September 22 to 25, 2026, and the company disclosed the outcome under Indian listing rules.
Key Points
1
In August, Zydus received final USFDA approval for a generic version of Ascorbic Acid Injection, a product with reported annual U.S. sales of about $11.6 million.
2
The approval covers two strengths of the injection—25,000 mg/50 mL and 5,000 mg/10 mL—and the USFDA designated the application as a Competitive Generic Therapy, which could make it eligible for 180-day exclusivity.
3
Zydus said the injection will be manufactured at its USFDA-approved facility in Jarod, near Vadodara, Gujarat, and marketed in the United States through Zydus Pharmaceuticals (USA) Inc.
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