Institute of Good Manufacturing Practices India®

USFDA concluded evaluation at Puducherry & Mangaluru facilities of Solara


A leading active pharmaceutical ingredient (API) provider, Solara Active Pharma Science Ltd., declared that the US Food and Drug Administration (FDA) have done two successful inspections of state of the art manufacturing facilities at Puducherry and Mangaluru of Solara.

The inspection proved that the 2 sites are in an "Acceptable State of Compliance" with Zero Form 483 inspectional observations from USFDA. The agency with their designated auditors evaluated the 2 facilities from 17th to 21st February 2020.

The company stated that the API manufacturing facility in Puducherry is their centre of excellence for the manufacturing of Ibuprofen and its derivative APIs. The facility was set up 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 MHRA, USFDA, EDQM, WHO, PMDA, TGA, COFEPRIS and KFDA.

Multiproduct manufacturing site of Solara at Mangaluru was set up 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 EDQM, MHRA, WHO, TGA, KFDA, PMDA and COFEPRIS.