Express Pharma

Ipca Labs gets warning letter from US FDA for three plants

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The manufacturing units are located at Ratlam, SEZ Indore and Piparia

Drug firm Ipca Laboratories has received warning letter from the US health regulator for three facilities on which the regulator had earlier imposed a import ban for not adhering to the good manufacturing norms.

The company is fully committed in resolving the issue at
the earliest, it added. The company, however, did not provide the details of the warning letter.

Earlier in regulatory filings to the bourses, Ipca had said that US FDA after inspections at its manufacturing units situated at Ratlam, SEZ Indore and Piparia had issued Form 483 observations “which subsequently resulted in issuance of import alert on these manufacturing units.”

The company has already voluntarily suspended shipments of its APls and formulations for the US market and since July 2014 has not shipped any APls or formulations to the US market except the products which are exempted from import alert, it added.

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