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USFDA refuses admission to APIs manufactured by Ipca Laboratories

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At its API manufacturing facility at Ratlam (Madhya Pradesh)

has received a communication from USFDA stating that all the drugs manufactured at the Company's API manufacturing facility at Ratlam (Madhya Pradesh) will be henceforth refused admission into United States (except API Chloroquine Phosphate, which will be reconsidered if shortage and/or medical necessity implication change) until the Company can demonstrate that the drugs manufactured at this manufacturing site and intended for the US market are in compliance with cGMP.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

First Published: Thu, June 15 2017. 20:52 IST
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