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Lupin shares at 52-week low over USFDA's warning letter on Goa, Indore plants

he imapct of USFDA warning will be a likely delay in new product approvals from Goa and Pithampur facilities.

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As soon as the company announced about the warning letter,the stock plunged to a 52-week low of Rs 851.20 in intraday trade.
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The stocks of Lupin Ltd nosedived to reach 52-week low on Tuesday. The 17% fall came after th firm has received a warning letter on Monday issued by the USFDA (United States Food and Drug Administration) pertaining to its two manufacturing facilities located in Goa and Indore (Pithampur Unit II).

As soon as the company announced about the warning letter,the stock plunged to a 52-week low of Rs 851.20 in intraday trade.

"The company has received a warning letter issued by the United States Food and Drug Administration (USFDA) on November 6, 2017 for our formulation manufacturing facilities at Goa and Indore (Pithampur Unit II)", Lupin said in a filing to BSE.

The imapct of USFDA warning will be a likely delay in new product approvals from Goa and Pithampur facilities.

"We are deeply disappointed to have received these outcome. While there will be no disruption of existing product supplies from either of these locations, there will be likely to be delay on new product approvals from these two facilities", Lupin said in a release.

The company upholds quality and compliance issues with utmost seriousness and remains fully committed to be compliant with cGMP quality standards across all the facilities, it added.

The company had earlier received three form 483 observations for the Goa facility on April 7, 2017 and six form 483 observations for Pithampur (Unit II) on May 19, 2017, Lupin said, adding that it had responded to all the observations.

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