USFDA successfully completes inspection at Solara Ambernath facility
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.
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.
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.”
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.
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.
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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