Dr Reddy's Laboratories Receives EIR from USFDA for Andhra Pradesh Facility

Dr Reddy's Laboratories announced the receipt of an establishment inspection report (EIR) from the USFDA for its API manufacturing unit in Srikakulam. The US health regulator classified the inspection as Voluntary Action Indicated, concluding the inspection. The company's shares saw a minor drop post-announcement.


Devdiscourse News Desk | New Delhi | Updated: 06-09-2024 16:41 IST | Created: 06-09-2024 16:41 IST
Dr Reddy's Laboratories Receives EIR from USFDA for Andhra Pradesh Facility
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Dr Reddy's Laboratories announced on Friday that it has received the establishment inspection report (EIR) from the US Food and Drug Administration (USFDA) for its active pharmaceutical ingredient manufacturing facility in Srikakulam, Andhra Pradesh.

The USFDA has classified the inspection as Voluntary Action Indicated (VAI), signaling that while some objectionable conditions were found, the agency is not prepared to take or recommend any administrative or regulatory action. The Hyderabad-based pharmaceutical company confirmed this development in a recent statement.

Earlier, on June 7, Dr Reddy's informed that the USFDA had issued a Form 483 with four observations following the inspection of its Srikakulam facility. In market reactions, shares of Dr Reddy's Laboratories saw a 0.42 percent dip, closing at Rs 6,669.75 apiece on the BSE on Friday.

(With inputs from agencies.)

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