Sun Pharma erases losses post clarification on USFDA observations

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Shares of Sun Pharmaceutical Industries recovered 4.7%, erasing more than half of their early morning losses on the National Stock Exchange (NSE) after the company said it will be submitting its response on the observations of Halol facility to the US drug regulator within 15 business days.

The stock has slipped 5.5% to Rs 640 on reports of the company getting six observations by the United States Food and Drug Administration (USFDA) for Halol unit.

At 03:20 pm; Sun Pharma was trading 2% lower at Rs 663, after hitting high of Rs 670 post announcements. The trading volumes on the counter more than doubled with a combined 22.73 million equity shares changed hands on the NSE and BSE so far.

“The US FDA conducted a Pre-Approval Inspection (PAI) of the company’s Halol facility (Gujarat, India) from August 27, 2018, to August 31, 2018. At the conclusion of the inspection, the agency issued a Form 483, with six observations,” Sun Pharma said on clarification on news report.

The Company will be submitting its response on the observations to the US FDA within 15 business days. Sun Pharma is committed to addressing these observations promptly, it added.


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