Solara Active Pharma Sciences Ltd. (Solara), a pure play active pharmaceutical ingredient provider, has announced that its multi-product manufacturing facility at Ambernath, Maharashtra has completed successfully 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 May 5-9, 2025.

Solara continues to stay focused on maintaining the highest level of compliance across its manufacturing facilities, asserted the company in a statement.

Commenting on the inspection outcome, Sandeep Rao, MD and 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 consecutive successful inspection outcome, with Zero 483 inspectional observations, across the Solara network of manufacturing facilities.”

He further added, “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.”

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.