The Agency with their designated investigator inspected the facility from 5th to 9th May 2025.
The inspection established that the site is in an “Acceptable State of Compliance” with Zero Form 483 inspectional observations from US FDA.
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.”
Solara Active Pharma Sciences is a pure play global API manufacturer supported by state-of-the-art R&D and manufacturing facilities. With 6 manufacturing facilities and an R&D Centre, the company offers a basket of diversified, high-value commercial APIs and contract manufacturing services.
The company reported consolidated net profit of Rs 8.09 crore in Q3 FY25 as compared with net loss of Rs 275.34 crore in Q3 FY24. Net sales increased 41.7% YoY to Rs 300.31 crore in Q3 FY25.
The scrip rose 0.54% to end at Rs 502.80 on the BSE.