Aurobindo Pharma shares down over 8% on US FDA observations

BL Internet Desk | Updated on November 14, 2019

File Photo   -  BusinessLine

Aurobindo Pharma declined sharply on the stock exchanges today after the US drug regulator issued a 'Form 483' with 14 observations to the company's facility in Hyderabad.

Aurobindo shares slumped 8.86% to Rs 394.40 on the BSE today. Volumes jumped nearly two-fold to 4.52 lakh shares as compared to average volume of 2.61 lakh shares for the last two-week period.

The company in its filing to the BSE stated: "Pursuant to Regulation 30 of the SEBI (Listing Obligations & Disclosure Requirements) Regulations, 2015, this is to inform you that the United States Food and Drug Administration (US FDA) inspected Company's Unit IV, a general injectable formulation manufacturing facility situated at Pashamylaram, Hyderabad, from 4th to 13th November 2019."

It further added: "At the end of the inspection, we have been issued a 'Form 483' with 14 observations. We believe that none of these observations are related to data integrity issues. The Company will respond to the US FDA within the stipulated timeline."



Published on November 14, 2019

Follow us on Telegram, Facebook, Twitter, Instagram, YouTube and Linkedin. You can also download our Android App or IOS App.

This article is closed for comments.
Please Email the Editor

You May Also Like