The agency, with its designated investigator, inspected the facility from 23rd to 26th January 2023.
Solara Active Pharma Sciences Ltd (Solara) announced that its new multipurpose API manufacturing facility at Visakhapatnam (Vizag), Andhra Pradesh completed successfully the inspection carried out by the US Food and Drug Administration (USFDA or Agency) 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 and has dedicated facilities for manufacturing Ibuprofen API and multipurpose facility in phase 1. The site manufactured 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.
Jitesh Devendra, managing director, commented, 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.
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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 company reported a consolidated net profit of Rs 0.45 crore in Q3 FY23 as against net loss of Rs 139.87 crore in Q3 FY22. Net sales surged to Rs 394.75 crore in Q3 FY23 as compared to Rs 100.34 crore in Q3 FY22.
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