Galaxy Surfactants extends fall after Tarapur plants receive Form 483

Galaxy Surfactants dipped 2% to Rs 1,400, extending its past three days 5% decline after the company received Form 483 for two of its facilities in Maharashtra after United States Food and Drug Administration (USFDA) audit.
“The company's two of the facilities (M3 & N46) at Tarapur (Maharashtra) have undergone USFDA inspection which was concluded on March 30, 2018. This is the first USFDA inspection and they issues Form 483 with total 13 observations. The M3 facility received 4 and N46 facility received 9 observations,” Galaxy Surfactants said in a regulatory filing.

All the observations are procedural in nature and none of them are related to any data integrity. The company is in midst to providing a comprehensive response to the observations and would be replying to the USFDA within the stipulated time, it added.

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