 "Aurobindo Pharma dips on USFDA procedural observations on Hyderabad unit")
Aurobindo Pharma dipped 4.7% to Rs 633 on BSE in late noon deal after the company said the US drug regulator issued six large procedural observations for its Unit III, a formulation manufacturing facility located at Bachupally, Hyderabad.
The United States Food and Drug Administration (USFDA) had conducted an inspection at the company’s Unit III a formulation manufacturing facility located at Bachupally, Hyderabad from 10th April, 2017 to 18th April, 2017.
“At the end of the inspection, we have been issued a Form 483 with 6 observations. The observations are all on procedural improvements. None of the observations are related to data integrity. The company will be responding as per the prescribed time lines,” Aurobindo Pharma said in BSE filing.
The company made clarification on news item appeared on CNBC TV18 dated 19th April, 2017 captioned ‘US FDA Issues 5-6 'largely procedural' observations to Aurobindo Pharma's Unit-III'.
At 03:14 pm; the stock was down 3.6% at Rs 639 on BSE, as compared to a marginal 0.01% decline in the S&P BSE Sensex. A combined 2.73 million shares changed hands on the counter on BSE and NSE so far. The stock hit a 52-week low of Rs 622 on BSE on December 26, 2016 in intra-day trade.
The United States Food and Drug Administration (USFDA) had conducted an inspection at the company’s Unit III a formulation manufacturing facility located at Bachupally, Hyderabad from 10th April, 2017 to 18th April, 2017.
“At the end of the inspection, we have been issued a Form 483 with 6 observations. The observations are all on procedural improvements. None of the observations are related to data integrity. The company will be responding as per the prescribed time lines,” Aurobindo Pharma said in BSE filing.
The company made clarification on news item appeared on CNBC TV18 dated 19th April, 2017 captioned ‘US FDA Issues 5-6 'largely procedural' observations to Aurobindo Pharma's Unit-III'.
At 03:14 pm; the stock was down 3.6% at Rs 639 on BSE, as compared to a marginal 0.01% decline in the S&P BSE Sensex. A combined 2.73 million shares changed hands on the counter on BSE and NSE so far. The stock hit a 52-week low of Rs 622 on BSE on December 26, 2016 in intra-day trade.
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