Sun Pharma has received the Establishment Inspection Report (EIR), for its Halol plant in Gujarat from the US Food and Drug Administration.
In a statement to the exchanges the company stated, “The agency concluded that the inspection is now closed and the issues contained in the Warning Letter issued in December 2015 have been addressed.” The Halol facility was inspected between February 12 and 23, by USFDA.
This EIR will now allow Sun Pharma to restart supplies from the Halol facility, to the US. Before the warning letter, Halol plant was contributing about USD 400 million in sales, approx 15% of the company’s total sales. The facility’s contribution later decreased to approx USD 250 million. Moreover, in FY18 US alone has contributed around 40% of Sun Pharma’s overall sales.
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