Aurobindo Pharma Ltd shares dropped nearly 6% in intra-day trade on Wednesday after the US health regulator issued six observations to the company’s manufacturing facility in Telangana.
At 2:29 pm, shares of Aurobindo Pharma stock were trading at Rs 452.35 apiece, down 4%, after hitting the day’s low of Rs 444.25. The stock has lost nearly 40% in the last one year compared with a 6.4% drop in the benchmark Nifty 50 index.
The US Food and Drug Administration (FDA) had inspected Aurobindo Pharma’s Unit 12 from 10 February 2020 to 14 February 2020 and then again from 17 February 2020 to 21 February 2020.
The pharma company has now received Form 483 with six observations for the unit which is a formulations facility that manufactures antibiotics, oral solid dosages and injectables.
According to the US FDA observations, the facilities at Unit 12 are not adequate to ensure prevention of contamination. Also, procedures to prevent microbial contamination are not established, while employees lack education and require further training. They failed to thoroughly review the unexplained discrepancy; procedures describing handling of complaints were deficiently written and followed; sensitivity of test methods were also not established.
Last month, Aurobindo Pharma’s Unit 4 was under the scanner after the US FDA had reopened its investigation on the manufacturing facility days after it granted the Voluntary Action Initiated (VAI) for the same. Unit 4 is a general injectable formulation manufacturing facility at Pashamylaram in Hyderabad. VAI means objectionable conditions or practices were found, but the US FDA is not taking or recommending any administrative or regulatory action.
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