Ipca Labs halts shipments to U.S. after FDA concerns

Jul 24 2014, 11:17 IST
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Ipca said the FDA issued it a so-called Ipca said the FDA issued it a so-called "Form 483," a letter in which the agency typically outlines concerns discovered during inspections
SummaryIpca Laboratories Ltd said it has temporarily suspended shipments to the United States...

Ipca Laboratories Ltd said it has temporarily suspended shipments to the United States from one of its drug ingredient manufacturing plants after the U.S. Food and Drug Administration expressed concerns regarding the unit.

The shipment halt from the company's Ratlam manufacturing facility located in central India will also impact Ipca's U.S. drug exports from its Silvassa and Indore plants, where the company makes drugs using ingredients from its Ratlam plant, Ipca said in a statement on Thursday.

Ipca said the FDA issued it a so-called "Form 483," a letter in which the agency typically outlines concerns discovered during inspections.

The company, which is one of the largest makers of drug ingredients in India, added it is "fully committed in resolving this issue at the earliest," and will resume shipments only after it has addressed all FDA concerns at Ratlam.

Ipca's shares fell as much as 10 percent to 753.55 rupees in early trade on the NSE on Thursday.

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