By: IPP Bureau
Last updated : April 30, 2026 8:27 am
The Puducherry facility, dedicated to Ibuprofen and its derivatives, is equipped with advanced infrastructure to serve both domestic and international markets
Solara Active Pharma Sciences Limited (Solara), a leading pure-play API manufacturer, has announced the successful closure of a US FDA inspection at its Ibuprofen manufacturing facility in Puducherry.
The company has reaffirmed continued compliance with current Good Manufacturing Practices (cGMP).
The unannounced inspection was conducted from February 2 to 6, 2026.
Solara underscored its ongoing commitment to maintaining stringent quality standards across all manufacturing operations.
Commenting on the outcome, Sandeep Rao, Managing Director & CEO, said: “We have successfully completed the FDA inspection at our Puducherry facility between 2nd to 6th Feb 2026. At the end of the inspection, four Form FDA 483 inspectional observations were issued by the investigator.
"The observations were procedural in nature. We had submitted our formal response to FDA well within the timeline set by the Agency and the Agency has issued an EIR and concluded that the inspection is closed.
"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.”
The company said the outcome reinforces its commitment to “Quality excellence consistently at all our manufacturing sites” and its broader strategy centered on regulatory compliance and global quality standards.
The Puducherry facility, dedicated to Ibuprofen and its derivatives, is equipped with advanced infrastructure to serve both domestic and international markets.