Page 2 - Divis Labs
Divi's Labs barred from exports to US after FDA import alert on Vizag unit
Hyderabad, 21 March:In a big setback to Hyderabad-based active pharmaceutical ingredients(APIs) maker Divis Laboratories Limited, the US Food and Drug Administration(US FDA) has issued import alert on the company's Unit 2 facility at Visakhapatnam of Andhra Pradesh, though with certain exemptions.The latest action comes after Divis management had submitted a 700-page response in the light of Form 483 observations issued by the US drug regulator in December 2016On December 7, 2016 the US FDA inspection team issued a Form 483 with 5 observations citing lack of proper control over computer systems, lack of proper maintenance of equipment and the documents at the facility. The company can not export products into the US from a site under import alert until the drug regulator reverses its action when it satisfies with the possible remedial steps taken in future.Divis' unit 2 contributes 65 percent of the company's total sales while its Unit 1 at Hyderabad accounts for the rest of the ...
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Divis Labs tanks 20% after USFDA issues import alert on Vizag unit
The stock tanked 20% to Rs 635, also its 52-week low on BSE in intra-day on back of heavy volumes.
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Near-term upsides capped for Divis Labs
Though the June quarter show was above expectations, the company cut margin forecast for FY17
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