Stories
Zydus Life's Ahmedabad Plant Receives One USFDA Observation; New Jersey Office Cleared
C
CNBC TV18•28-09-2026, 19:00
Zydus Life's Ahmedabad Plant Receives One USFDA Observation; New Jersey Office Cleared
- •Zydus Lifesciences' manufacturing facility at SEZ II, Ahmedabad, concluded a USFDA inspection with one observation, with no data integrity issues reported.
- •The cGMP inspection at the Ahmedabad plant was conducted from September 21 to September 28, 2026.
- •A separate USFDA inspection of Zydus's pharmacovigilance system at its New Jersey office concluded with nil observations.
- •Zydus received final USFDA approval in August for its generic Ascorbic Acid Injection, a Competitive Generic Therapy with potential 180-day exclusivity.
- •In Q1, Zydus reported a 35.9% year-on-year profit decline to ’939.8 crore, while revenue increased 22% to ’8,017 crore.
Key Questions Answered
The USFDA inspection at Zydus Lifesciences' manufacturing facility at SEZ II in Ahmedabad concluded with one observation, with no data integrity-related observations noted.
The USFDA inspection of the pharmacovigilance and post-marketing surveillance system at the New Jersey office concluded with nil observations.
In its June-quarter results, Zydus Lifesciences reported a 35.9% year-on-year decline in profit to ₹939.8 crore, while revenue rose 22% to ₹8,017 crore.
