Solara US FDA Puducherry Inspection Closed VAI

Solara Active Pharma Sciences received a closed EIR from US FDA with a VAI classification for its unannounced Ibuprofen facility inspection in February 2026.
The inspection resulted in four procedural Form FDA 483 observations, to which the company submitted a timely response leading to the closure.
The Puducherry facility, which manufactures Ibuprofen for global markets, is approved by multiple international regulators including US FDA, EDQM, and MHRA.
Management emphasized that quality and regulatory compliance remain a key pillar of the company's growth strategy following the successful inspection outcome.