The company has received the EIR (establishment inspection report) from the USFDA for the inspection conducted at its Halol facility (Gujarat, India) during the period February 12-23, 2018.
The company has received the EIR (establishment inspection report) from the USFDA for the inspection conducted at its Halol facility (Gujarat, India) during the period February 12-23, 2018.
The agency concluded that the inspection is now closed and the issues contained in the warning letter issued in December 2015 have been addressed, company said in release.
Dilip Shanghvi, Managing Director of Sun Pharma said, “This is an important development for Sun Pharma. We remain committed to following the highest levels of quality and 24x7 cGMP compliance at all our manufacturing facilities globally."
The EIR will allow Sun Pharma to restart supplies from the Halol facility to the US.
Prior to the warning letter, Halol was contributing about USD 400 million in sales, which was nearly 15 percent of the company's total sales. The facility’s contribution later declined to about USD 250 million. US alone has contributed around 40 percent of Sun Pharma overall sales in FY18.
At 09:18 hrs Sun Pharmaceutical Industries was quoting at Rs 556.75, up Rs 16.25, or 3.01 percent on the BSE.
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