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USFDA issues warning letter for Cadila Healthcare's Moraiya facility

The formulation unit 45% of the firm's US sales; Cadila says letter does not impact its existing business in the United States for now

Cadila Healthcare
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Vinay Umarji Ahmedabad
Drug maker Cadila Healthcare Ltd (Zydus Cadila) received a warning letter today from the US Food and Drugs Administration (USFDA) for its Moraiya formulation unit.

Contributing roughly $400 million (Rs 2,800 crore), or 45 per cent of the firm's US sales, the Moraiya plant saw its case escalate with the US regulator on getting an official action indicated (OAI) after inspection between April 22 and May 3.

A warning letter is an escalation of Form 483 (which notes adverse observations about quality and compliance of a facility that needs the manufacturer needs to address) by the USFDA. Exports from a facility stop

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