Solara Active Pharma Sciences Ltd. (Solara) announced that its new state-of-the-art multipurpose API manufacturing facility at Visakhapatnam (Vizag), Andhra Pradesh 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.

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. The site positions Solara as the only Global Company offering Ibuprofen from two USFDA-approved manufacturing sites (Puducherry and Vizag), enhancing supplies for its global partners.

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.