Shares of Aurobindo Pharma tumbled over 9 percent on Thursday after the United States Food and Drug Administration (USFDA) issued a 'Form 483' to its Hyderabad facility with 14 observations.
The stock shed as much as 9.4 percent to Rs 392.60 per share on BSE. At 10:05 am, the stock was trading 8.2 percent lower at Rs 397.45 as compared to a 0.1 percent or 37 points fall in BSE Sensex at 40,079.
Aurobindo Pharma informed USFDA inspected Company's Unit IV, a general injectable formulation manufacturing facility situated at Pashamylaram, Hyderabad, from 4th to 13th November 2019. At the end of the inspection, they were issued a 'Form 483' with 14 observations, it said in a regulatory filing.
The pharma company also added that they believe that none of these observations are related to data integrity issues and the company will respond to the USFDA within the stipulated timeline.
Earlier this week, Aurobindo Pharma also reported its September-quarter numbers. The drugmaker net profit rose 4.6 percent year-on-year (YoY) to Rs 639.5 crore in Q2 on higher expenses. It posted a net profit of Rs. 611.4 crore in the corresponding quarter of the previous year. Revenue rose 17.9 percent YoY to Rs. 5,600.5 crore, while the expenses rose 20 percent YoY to Rs 4744.5 crore.