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Sun Pharma says USFDA issues at Halol over, two specialty drugs may get nod

While the plant was served warning letter by US regulator in December 2015, product approvals were frozen in September 2014

Sun Pharma. (Photo: Reuters)
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Sun Pharma. (Photo: Reuters)

Aneesh Phadnis Mumbai
Sun Pharmaceutical Industries today announced the resolution of regulatory compliance issues at Halol plant.
Halol plant was served a warning letter by US Food and Drug Administration in
December 2015. No new products manufactured at the facility have been approved since September 2014 when it received adverse observations from the US regulator.
 
In a stock exchange notification on Tuesday, the company said it has received the Establishment Inspection Report (EIR) from the USFDA for the inspection conducted at its Halol plant during  February 12-23.

Topics : Sun Pharma