“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.
Galaxy Surfactants have five manufacturing facilities India, one located at Taloja (Maharashtra), three located at Tarapur (Maharashtra) and one located at Jhagadia (Gujarat).
The stock was trading at its lowest level since listing on February 8, 2018, fallen 17% as compared to 2% decline in the S&P BSE Sensex during the period.
Galaxy Surfactants raised Rs 9,370 million through initial public c offer (IPO) was subscribed 19.96 times. A manufacturer of specialty chemicals had made a decent debut, as the scrip got listed at Rs 1,698 on BSE, a premium of 15% over its issue price of Rs 1,480.