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
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.”
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The Ambernath multi-product API manufacturing facility was established in the year 2004 and is equipped with appropriate infrastructure to include several independent production blocks and related packaging sections. This site is inspected by various Regulatory Authorities including US FDA, EDQM, WHO, PMDA, and KFDA.
Solara Active Pharma Sciences Ltd is a global API manufacturer supported by state-of-the-art R&D and manufacturing facilities. With 6 manufacturing facilities and an R&D Centre, Solara offers a basket of diversified Commercial APIs and Contract manufacturing services. Its API facilities are approved by various international regulatory agencies including the USFDA, EDQM, MFDS, WHO, PMDA etc.
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