Aurobindo Pharma drops 4% after USFDA observations to Hyderabad unit

Aurobindo Pharma shares today closed with losses of nearly 4 per cent, eroding Rs 1,365 crore from its market capitalisation, after one of its units received nine USFDA observations.
The drug firm today said the US health regulator has issued nine observations after inspection of its unit-4 formulation facility in Hyderabad.
During the day the stock opened on a weak note at Rs 605.40, then fell to an intra-day low of Rs 590, down 5.46 per cent over its previous closing price.
At close, the stock was quoted at Rs 600.80, down 3.74 per cent.
Following the decline in the counter, the market capitalisation of the company declined by Rs 1,365.18 crore to Rs 35,199.82 crore.

A similar movement was seen on NSE, where the stock opened at Rs 603.10, then fell to an intra-day low of Rs 590, down 5.46 per cent over its last close. The stock finally settled at Rs 599.70, down 3.91 per cent.

The United States Food and Drug Administration (USFDA) conducted an inspection at the companys unit 4, a formulation manufacturing facility in Hyderabad from February 12-20, 2018, Aurobindo Pharma said in a BSE filing.
"... at the end of the inspection, we were issued a Form 483 with nine observations, " it added.
None of the observations is related to data integrity or is repetitive in nature, Aurobindo Pharma said. It, however, did not provide any detail regarding the observations.

"We are in the midst of providing a comprehensive response to the observations and would be replying to the FDA within 15 working days from the date of closure (February 20, 2018) of audit," it added.
As per the USFDA, a form 483 notifies a companys management of objectionable conditions at its facility.