Stories
Zydus Lifesciences Aces USFDA Inspection with Nil Observations at New Jersey Office
C
CNBC TV18•26-09-2026, 13:22
Zydus Lifesciences Aces USFDA Inspection with Nil Observations at New Jersey Office
- •Zydus Lifesciences announced that a USFDA inspection of its pharmacovigilance and post-marketing surveillance system at its New Jersey, US office concluded with nil observations.
- •The inspection was conducted from September 22 to September 25, 2026, covering the company's pharmacovigilance and post-marketing surveillance system onsite.
- •This development was disclosed under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015.
- •Earlier in August, Zydus Lifesciences received final USFDA approval for its generic Ascorbic Acid Injection, with annual US sales of approximately $11.6 million.
- •The approved Ascorbic Acid Injection USP is for short-term scurvy treatment and will be manufactured at Zydus' USFDA-approved injectable facility in Jarod, Gujarat, for the US market.
Key Questions Answered
The USFDA inspection of Zydus Lifesciences' pharmacovigilance and post-marketing surveillance system at its New Jersey office concluded with nil observations.
The USFDA inspection at the company's New Jersey, US office was conducted onsite from September 22 to September 25, 2026.
The inspection specifically covered the company's pharmacovigilance and post-marketing surveillance system located at its US office in New Jersey.
