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Galaxy Surfactants hits 52-week low on 13 observations for Tarapur unit from USFDA

All the observations are procedural in nature and none of them are related to any data integrity, company said in release.

April 03, 2018 / 01:32 PM IST
 
 
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Shares of Galaxy Surfactants touched a 52-week low of Rs 1,430, slipping 4.5 percent intraday Tuesday as company received Form 483 for two of its facilities.

The company's two of the facilities (M3 & N46) at Tarapur (Maharashtra) have undergone United States Food and Drug Administration (USFDA) inspection which was concluded on March 30, 2018

This is the first USFDA inspection and they issues Form 483 with observations. The M3 facility received 4 and N46 facility received 9 observations.

All the observations are procedural in nature and none of them are related to any data integrity, company said in release.

The company is in midst to providing a comprehensive response to the observations and would be replying to the USFDA within the stipulated time.

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These facilities manufacture two products, Octyl Methoxy Cinnamate and Octocrylene, which have USP monograph.

The revenue from the US market for these products is less than 1% of the consolidated revenues and company not expect any financial impact of the same.

At 13:24 hrs Galaxy Surfactants Ltd. was quoting at Rs 1,467, down Rs 30.95, or 2.07 percent on the BSE.

Posted by Rakesh Patil
Moneycontrol News
first published: Apr 3, 2018 01:32 pm

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