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Dr. Reddy’s Srikakulam facility gets 3 U.S. FDA observations

Dr. Reddy’s Srikakulam facility gets 3 U.S. FDA observations

Posted on July 30, 2026 By admin


A view of Dr. Reddy’s Lab facility near Hyderabad.
| Photo Credit: The Hindu

Dr. Reddy’s Laboratories has been issued three observations by the U.S. Food and Drug Administration (U.S. FDA) after an inspection of its facility in Srikakulam, Andhra Pradesh.

The U.S. FDA has completed a Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection at the FTO-SEZ Process Unit-02 in Srikakulam. The inspection was conducted between July 20 and July 29, the Hyderabad-based generic drugmaker said in a filing on Wednesday (July 29, 2026).

“We have been issued a Form 483 with three observations, which we will address within the stipulated timeline,” Dr. Reddy’s said. The company’s shares closed flat on Thursday (July 30, 2026) at ₹1,144.35 a piece on the Bombay Stock Exchange.

Published – July 30, 2026 07:17 pm IST



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