USFDA concludes inspection at Solara Active Pharma Sciences Vizag facility with Zero 483 inspectional observations

Bengaluru: Solara Active Pharma Sciences Ltd has announced that its new state-of-the-art multipurpose API manufacturing facility at Visakhapatnam (Vizag), Andhra Pradesh has completed successfully the inspection carried out by the US Food and Drug Administration (US FDA or Agency).

The Agency, with its designated investigator, inspected the facility from 23rd to 26th January 2023. The inspection established that the site is in an “Acceptable State of Compliance” with Zero Form 483 inspectional observations from the agency.

Jitesh Devendra, Managing Director, commented, “We are happy with the successful inspection outcome of our new greenfield API site at Vizag with Zero 483 inspectional observations. This is the first regulatory inspection we have undergone at the site since its commissioning. This outcome demonstrates our relentless focus on world-class quality and compliance, which remains a key pillar of our strategy and validates the quality systems the Company has institutionalized across its manufacturing network. The Vizag facility is differentiated in design and supports the manufacturing of APIs to ensure supply security and cost leadership.”

The Vizag facility of the Company is a green field project spread over 40 acres and has dedicated facilities for manufacturing Ibuprofen API and multipurpose facility in phase 1. The facility has also started validating other APIs to register in various regulated markets across the globe. The site offers a unique capability to the Company for manufacturing various APIs with scale and operational flexibility to achieve a competitive advantage. Earlier, in November 2022, Solara’s Vizag facility had received a Certificate of Suitability (CEP) approval for the manufacture of Ibuprofen API from the European Directorate for the Quality of Medicines (EDQM), the first international regulatory approval for this new facility.

Read also: Solara Active Pharma Sciences Vizag facility gets European approval (CEP) to manufacture Ibuprofen API