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Dr. Reddy’s gets inspection report from USFDA for Srikakulam-based API plant

Posted on September 6, 2024 By admin


Dr. Reddy’s Laboratories on Friday (September 6, 2024) said it has received the establishment inspection report (EIR) from the U.S. health regulator for its active pharmaceutical ingredient manufacturing facility (CTO-6) in Srikakulam, Andhra Pradesh.

The U.S. Food and Drug Administration (USFDA) has classified the inspection as Voluntary Action Indicated (VAI) and concluded that the inspection is close, the Hyderabad-based drug maker said in a statement.

As per USFDA, VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

On June 7 this year, Dr. Reddy’s had stated that the U.S. health regulator has issued Form 483 with four observations after inspecting its Srikakulam-based facility.

Shares of the company on Friday ended 0.42% down at ₹6,669.75 apiece on the BSE.

Published – September 06, 2024 11:03 pm IST



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