Solara Active Pharma - a leading Active Pharmaceutical Ingredient provider - has informed stock exchanges that the USFDA has concluded inspection at its manufacturing facility at Visakhapatnam, which is now rated to be in 'Acceptable State of Compliance' by the regulator.
"We are very happy with the successful inspection outcome of our Visakhapatnam API site with Zero 483 inspectional observation. This is the second US FDA inspection we have undergone at this site," Poorvank Purohit, MD & CEO of Solara said.
Solara has two FDA inspected manufacturing sites (Puducherry and Visakhapatnam) for Ibuprofen substance.
The company remains stay focused on maintaining highest compliance across manufacturing facilities. "We remain agile to the increasing requirements on quality and compliance, and I am confident that we will sustain our quality culture and anchor it further," Poorvank Purohit said.
Solara’s Visakhapatnam facility is a 40-acre green field project dedicated to manufacture Ibuprofen API. The facility also makes key starting material for Ibuprofen, thus achieving backward integration of supply chain.
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