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Indoco Remedies gets two minor observations from USFDA for Goa plants

"The inspection concluded with the company receiving two minor observations, none of which are repeat in nature," Indoco Remedies said in a regulatory filing.

November 22, 2018 / 03:59 PM IST
 
 
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Drug firm Indoco Remedies on Thursday said it has received two minor observations from the US health regulator for its Goa-based two plants. The US Food and Drug Administration (USFDA) inspected the manufacturing facilities between November 14-21.

"The inspection concluded with the company receiving two minor observations, none of which are repeat in nature," Indoco Remedies said in a regulatory filing.

Indoco said it is in the process of responding to the observations within the stipulated time of 15 days, it added.

The facility had earlier received a warning letter from the USFDA in March 2017.

"This positive development will now pave the way for approval of our pending ANDAs with consequent boost to revenues from the US market," Indoco Remedies Managing Director Aditi Kare Panandikar said.

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Headquartered in Mumbai, Indoco Remedies has nine manufacturing facilities and has presence across 55 countries.

Shares of the company Thursday ended 20 percent up at Rs 206.40 on the BSE.
PTI
first published: Nov 22, 2018 03:53 pm

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