Sun Pharma receives EIR for its crucial Halol plant in Gujarat, US health regulator clears drug major
Sun Pharmaceutical Industries said it has received establishment inspection report (EIR) from US health regulator for its Halol facility in Gujarat
New Delhi: Drug major Sun Pharmaceutical Industries on Tuesday said it has received establishment inspection report (EIR) from the US health regulator for its Halol facility in Gujarat.
The company has received EIR from the United States Food and Drug Administration (USFDA) for the inspection conducted at the Halol facility during the period 12-23 February, 2018, Sun Pharma said in a filing to BSE.
"The agency concluded that the inspection is now closed and the issues contained in the warning letter issued in December 2015 have been addressed," it added.
Commenting on the development, Sun Pharma MD Dilip Shanghvi 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."
In February, the USFDA had issued three observations after inspecting the facility. The company had said it was preparing the response to the observations.
Sun Pharma had received a warning letter from the USFDA over violation of manufacturing norms in its facility at Halol in Gujarat in end of 2015.
This followed inspection of the facility in September 2014 by FDA inspectors.
Shares of Sun Pharmaceutical Industries on Tuesday closed at Rs 540.50 per scrip on BSE, up 1.03 percent from its previous close.
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The BJP veteran served as chief minister of Gujarat in 1995 and then from 1998 to 2001. He was succeeded by Narendra Modi, who held the post till he became prime minister in 2014