Now Reading: USFDA closes inspection of Strides’ Bengaluru plant with clean report
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USFDA closes inspection of Strides’ Bengaluru plant with clean report
USFDA closes inspection of Strides’ Bengaluru plant with clean report
Strides Pharma Science said on Thursday that the US Food and Drug Administration has issued a clean Establishment Inspection Report for its flagship manufacturing facility in Bengaluru, closing the regulatory inspection without…
Strides Pharma Science said on Thursday that the US Food and Drug Administration has issued a clean Establishment Inspection Report for its flagship manufacturing facility in Bengaluru, closing the regulatory inspection without further action. The USFDA inspected the plant between May 12 and May 20, 2026, under current Good Manufacturing Practices and initially issued a Form 483 with five observations.
Strides submitted a comprehensive response within the timeline and implemented corrective and preventive actions. The USFDA classified the outcome as Voluntary Action Indicated and issued the EIR, concluding the process. The facility makes tablets, capsules and oral liquids for regulated and other international markets, supporting both existing commercial products and future growth.
Indian Opinion Analysis
A VAI classification means the USFDA found deficiencies but does not consider them serious enough to warrant further regulatory or legal action. For Strides, this closure removes a cloud over its flagship Bengaluru plant, which supplies tablets, capsules and oral liquids to regulated markets including the US and Europe. The company had reported a net loss of Rs 47 crore in the June quarter, a clean chit from the USFDA is crucial to restore buyer confidence and protect its export revenue, which stood at Rs 412 crore last fiscal. Investors will now watch whether the stock, which fell 12% this year, recovers on this news.
Source: thehindu.com
This story was synthesised by AI from the source linked above.
