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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 14th to 17th May 2024.
Solara’s Visakhapatnam (Vizag) facility is a green field project spread-over an area of 40 acres and has dedicated facilities for the manufacture of Ibuprofen API. The facility also manufactures its key starting material for Ibuprofen and thus achieved backward integration of its critical supply chain and ensures business continuity to its customers. The company’s (Vizag) facility has also started validation of other API’s to register in various regulated markets across the globe.
Solara has two FDA inspected manufacturing sites (Puducherry and Visakhapatnam) for Ibuprofen drug substance.
Poorvank Purohit, MD & CEO, Solara Active Pharma Sciences, said, “We are very happy with the successful inspection outcome of our Visakhapatnam API site with Zero 483 inspectional observation. This is the second US FDA inspection we have undergone at this site. This continues to demonstrate our relentless focus on world-class quality and compliance, which remains a key pillar of our growth strategy. We remain agile to the increasing requirements on quality and compliance, and I am confident that we will sustain our quality culture and anchor it further.”
Solara Active Pharma Sciences engaged in the business of manufacturing, production, processing, formulating, sale, import, export, merchandising, distributing, trading of and dealing in active pharmaceutical ingredients.
The counter fell 0.24% to end at Rs 484.25 on Saturday, 28 May 2024.
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