Solara Active Pharma's Ambernath Plant Clears USFDA Check

Solara Active Pharma Sciences reported that its Ambernath facility in Maharashtra, having multiple products manufacturing, passed inspection by the United States Food and Drug Administration (USFDA) with zero observations. The agency's appointed investigator from 5th to 9th May 2025 carried out the inspection, which reaffirmed the site to be in an acceptable state of compliance and yielded no Form 483 observations.

Sandeep Rao, CEO and Managing Director at Solara, was pleased with the result, saying, "We are extremely pleased with the successful inspection result of our Ambernath API facility with Zero 483 inspectional observations. This is the third consecutive successful inspection with zero observations from our manufacturing network. It reinforces our dedication to regulatory excellence and our emphasis on having world-class quality and compliance standards, which form the core of our growth strategy."

Solara Active Pharma Sciences is a pure-play, global API manufacturer with six production facilities and a specialized R&D facility. The firm focuses on high-value commercial APIs and contract manufacturing services, backed by sophisticated research and production capabilities.

On the financial front, Solara posted a consolidated net profit of ?8.09 crore in Q3 FY25 from a net loss of ?275.34 crore in the same period last year. Net sales also posted a robust 41.7% year-on-year growth to ?300.31 crore in Q3 FY25.

The stock of the company jumped 0.54% to settle at ?502.80 on the BSE following the announcement.