Solara Pharma’s manufacturing site garners positive FDA review

Solara Active Pharma Sciences Ltd’s (Solara Pharma) manufacturing facility in Cuddalore has garnered approval from the US Food and Drug Administration (US FDA). Following an inspection from July 31 to August 4, 2023, the facility received a green signal, indicating its “Acceptable State of Compliance” without any Form 483 observations from the US FDA.

Enhanced Compliance Status for Solara’s Facility

With the satisfactory outcome of the inspection, the Cuddalore site’s classification will now be upgraded to NAI (No Action Indicated). This further fortifies the facility’s standing, which had previously cleared regulatory inspections by the World Health Organization (WHO) in January 2023, and an EU-GMP Inspection conducted jointly by health authorities from the Czech Republic and Portugal in February 2023.

CEO’s Comments on the Achievement

Poorvank Purohit, MD and CEO of Solara Pharma, expressed his contentment, stating, “We are happy with the outcome of the FDA inspection with Zero 483 inspectional observations. This is the third consecutive successful regulatory inspections outcome at our Cuddalore site. The result showcases our commitment to global regulatory standards and consistent quality.”

A Brief Overview of the Cuddalore Facility

Established in 1991, the Cuddalore multi-product API manufacturing hub boasts state-of-the-art infrastructure, including multiple production blocks and packaging sections. Apart from the recent inspections, the site has been previously assessed by various other Regulatory Authorities, further establishing its reputation in the pharmaceutical manufacturing sector.