USFDA successfully completes inspection at Solara Ambernath facility
Written By : Ruchika Sharma
Medically Reviewed By : Dr. Kamal Kant Kohli
Published On 2025-05-12 06:00 GMT | Update On 2025-05-12 06:00 GMT
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Chennai: Solara Active Pharma Sciences Limited, an Active Pharmaceutical Ingredient provider, has announced that its multi-product manufacturing facility at Ambernath, Maharashtra has successfully completed the inspection carried out by the US Food and Drug Administration (US FDA).
The inspection established that the site is in an “Acceptable State of Compliance” with Zero Form 483 inspectional observations from US FDA.
The Agency with their designated investigator inspected the facility from 5 th to 9 th May 2025.
Commenting on the Inspection Outcome, Sandeep Rao, MD & CEO said, “We are very happy with the successful inspection outcome of our Ambernath API site with Zero 483 inspectional observations. This is the third (3rd) consecutive successful inspection outcome, with Zero 483 inspectional observations, across the Solara network of manufacturing facilities. The inspection outcome demonstrates our commitment to regulatory excellence at our global manufacturing sites and relentless focus on world-class quality and compliance, which remains a key pillar of our growth strategy. We stay committed to exhibit the highest level of compliance and constant focus on world-class quality with the validated quality systems established across Solara’s manufacturing network.”
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