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Zydus Cadila receives warning letter from USFDA for Moraiya-based formulation facility


Zydus Cadila receives warning letter from USFDA for Moraiya-based formulation facility

New Delhi: Drug firm Zydus Cadila on Monday said it has received a warning letter from the US health regulator for its Moraiya-based formulation facility. The company said it has already taken multiple steps after the inspection of the facility by the US Food and Drug Administration (USFDA) and would continue to take all necessary steps in future as well to ensure that the health regulator is fully satisfied with its remediation of the above facility.

“We are confident of responding to the USFDA to address the observations within the statutory time permitted in the letter,” Zydus Cadila said in a regulatory filing.

Read Also: Zydus Cadila gets USFDA nod for Colesevelam Hydrochloride tablets for lowering cholesterol

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The warning letter does not affect the existing business of the company in the US and the existing product supplies from the Moraiya facility will continue, it added.

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The company remains committed to patient safety and meeting the expectations of regulatory compliances, the Gujarat-based firm said.

Read Also: Zydus announces positive results from EVIDENCES IV Phase 2 clinical trial of Saroglitazar Magnesium in NAFLD and NASH


Source: PTI
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