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Strides Arcolab falls 7% on warning letter from USFDA

Sterile manufacturing facility 2 at Bangalore of Agila Specialties Private Limited, a wholly owned subsidiary of the company, has received a warning letter from the United States Food and Drug Administration (US FDA). The stock fell as much as 6.8 percent intraday Monday.

September 16, 2013 / 04:23 PM IST
 
 
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Moneycontrol Bureau


Investors started selling shares of Strides Arcolab after the company announced that its sterile manufacturing facility 2 (SFF) at Bangalore of Agila Specialties Private Limited, a wholly owned subsidiary of the company, has received a warning letter from the United States Food and Drug Administration (US FDA). The stock fell as much as 6.8 percent intraday Monday.


"The US FDA inspected SFF in the month of June 2013 and the inspection resulted in issuance of Form FDA 483 with observations. The company responded to the 483 observations by implementing corrective actions," company said in its filing.


The company says it is committed to work collaboratively and expeditiously with the US FDA to resolve concerns cited in the warning letter in the shortest possible time.


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According to its release, the Oncology facility at Bangalore of Agila Specialties Private Limited was also inspected recently by the US FDA and this facility has cleared the inspection with "Zero 483 status".


The company has 8 US FDA approved sterile manufacturing facilities, Strides says.

At 14:37 hours IST, the stock was down 3.59 percent at Rs 867.85 amid large volumes on the Bombay Stock Exchange.

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