Dr Reddy’s gets US FDA inspection report for Srikakulam-based API plant | Company News

Dr. Reddy’s Laboratories

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 plant (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 drugmaker said in a statement.

According to the 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 said that the US health regulator had issued Form 483 with four observations after inspecting its facility in Srikakulam.

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

(Only the headline and image of this report may have been reworked by Business Standard staff; the rest of the content is auto-generated from a syndicated feed.)

First published: September 6, 2024 | 17:23 IS

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