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USFDA has removed partial lifting of import alert on APIs manufacturing facility at Ratlam: Ipca Lab.

Date: 25-06-2020
Subject: USFDA has removed partial lifting of import alert on APIs manufacturing facility at Ratlam: Ipca Lab
Ipca Laboratories on Wednesday said the US health regulator has removed the partial lifting of import alert on its active pharmaceuticals ingredients (APIs) manufacturing facility situated at Ratlam, in Madhya Pradesh with no shortage of Chloroquine Phosphate drug in the US.

In a regulatory filing Ipca Laboratories said, the US Food and Drug Administration (USFDA) has informed the company that the "shortage implications for chloroquine phosphate API has changed and chloroquine phosphate drug product is no longer in shortage and therefore, no shipment of API chloroquine phosphate will be excluded from the import alert."

USFDA has also informed that due to potential shortage implications and/or medical necessity, exception to the import alert was made for API Hydroxychloroquine Sulfate and "this exception will be re-considered if the shortage implications change," the filing added.

In March, USFDA had partially lifted import alert imposed on the company's API plant at Ratlam and formulations units at Pithampur in the same state and Piparia in Silvassa, allowing shipments of hydroxychloroquine sulphate and chloroquine phosphate APls; and hydroxychloroquine sulphate tablets produced at these facilities to the US.

However, the exception was subject to re-consideration if the shortage implications changed, USFDA had said.

Due to violation of good manufacturing practices (GMPs) as per USFDA norm, the company's plants have been under import alert, under which the regulator has the rights for detention without physical examination of drugs from firms which have not met the GMPs.

Source:- moneycontrol.com

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