Caraco agrees to undertake action to get USFDA ban lifted
Press Trust of India / New York Oct 01, 2009, 20:16 IST
Sun Pharma's US-based subsidiary Caraco Pharmaceuticals has agreed to undertake a series of measures as per requirements of the US health regulator Food and Drug Administration (FDA) to get a ban on its manufacturing units lifted.
As per the voluntary agreement reached between the company and the USFDA, Caraco will take a series of measures and, when satisfied, the FDA will permit it to resume manufacturing and distributing those products that are manufactured in Detroit area facilities.
"The company is working expeditiously to satisfy the requirements of the consent decree (voluntary agreement) and has already retained independent Good Manufacturing Practice Certificate (cGMP) experts for review of the company's operations and to facilitate a successful result," Caraco said in a filing to Securities Exchange Commission.
Caraco is currently facing a ban on manufacturing pharmaceutical products at its Detroit and Michigan facilities for violating USFDA's norms on cGMP.
Earlier in June this year, USFDA officials had siezed 33 drugs manufactured at its Detroit unit and temporarily stopped all manufacturing activities. The regulator had also seized all drugs manufactured by Caraco, even including raw materials and active pharmaceutical ingredients.
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