USFDA conclude inspections at Solara’s Puducherry and Mangalore facility with Zero 483 observations

The US Food and Drug Administration (USFDA) has completed two successful inspections of Solara’s state of the art manufacturing facilities at Puducherry and Mangalore. The inspection established that the two sites are in an acceptable state of compliance with Zero Form 483 inspectional observations from USFDA. The agency with their designated auditors inspected the two facilities from February 17, 2020 to February 21, 2020.
The Puducherry API manufacturing facility is center of excellence for the manufacturing of Ibuprofen and its derivative APIs. The facility was established in the year 1986 and is one of the largest Ibuprofen manufacturing sites in the world. This site is inspected by various regulatory authorities including USFDA, MHRA, EDQM, WHO, PMDA, TGA, KFDA, and COFEPRIS. Solara’s multiproduct manufacturing site at Mangalore was established in 1997 and has best in class infrastructure and capabilities to produce niche high-value APIs and API intermediates. In addition to the USFDA, the site also maintains its regulatory status with other leading global agencies such as MHRA, EDQM, WHO, PMDA, TGA, KFDA, and COFEPRIS.
These inspection outcomes are Solara’s fourth consecutive US FDA audit with Zero 483s. In December 18, January 19, and July 19, the USFDA concluded the inspections at facilities at Solara Research Centre(SRC), Chennai and API manufacturing sites at Ambernath and Cuddalore with zero 483s.