USFDA inspects Solara Active Pharma Sciences’ Visakhapatnam Facility

20 May 2024 Evaluate

The US Food and Drug Administration (USFDA) has completed successfully the inspection at Solara Active Pharma Sciences’ new state-of-the-art multipurpose API manufacturing facility at Visakhapatnam, Andhra Pradesh. The inspection established that the site is in an ‘Acceptable State of Compliance’ with Zero Form 483 inspectional observations from USFDA. The Agency with their designated investigator inspected the facility from May 14 to 17, 2024.

Solara’s Visakhapatnam (Vizag) facility is a green field project spread-over an area of 40 acres and has dedicated facilities for the manufacture of Ibuprofen API. The facility also manufactures its key starting material for Ibuprofen and thus achieved backward integration of its critical supply chain and ensures business continuity to its customers. Solara’s (Vizag) facility has also started validation of other API’s to register in various regulated markets across the globe.

Solara has two FDA inspected manufacturing sites (Puducherry and Visakhapatnam) for Ibuprofen drug substance. Solara continues to stay focused on maintaining the highest level of compliance across its manufacturing facilities.

Solara Active Pharma Sciences is a young, dynamic, entrepreneurial and customer oriented API manufacturer.


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