Dr Reddy’s gets inspection report from USFDA for Srikakulam-based API plant, ET HealthWorld

by Pelican Press
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Dr Reddy’s gets inspection report from USFDA for Srikakulam-based API plant, ET HealthWorld

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

The US 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 US health regulator has issued Form 483 with four observations after inspecting its Srikakulam-based facility.

Shares of the company on Friday ended 0.42 per cent down at Rs 6,669.75 apiece on the BSE.

  • Published On Sep 6, 2024 at 05:51 PM IST

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