Solara Active Pharma Sciences’ Tamil Nadu unit has been found to be in “acceptable state of compliance” by the United States Food and Drug Administration (US FDA), the company told stock exchanges on August 7.
“We would like to update you that Solara has successfully completed the inspection carried out by the US FDA at its Cuddalore facility (Tamil Nadu),” the statement said.
Investigators of the US drug regulator inspected the unit between July 31 and August 4 and established that it was in “acceptable state of compliance” with Zero Form 483 inspectional observations from the agency.
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“With this successful inspection outcome, the current inspection classification of the Cuddalore site shall be reinstated to NAI (No Action Indicated),” the company added.
Solara’s Cuddalore API site is a multi-product facility, making a wide range of active pharmaceutical ingredients for various markets across the globe, including the US, Europe and Japan.
At 10:,43 am, the stock was trading at Rs 398.55 on NSE, up 1.36 percent from the previous close.
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