Ahmedabad-based Cadila Healthcare (Zydus Cadila) on Wednesday said its formulations manufacturing facility at Moraiya, near Ahmedabad, has received an Establishment Inspection Report (EIR) from the US Food and Drugs Administration signifying the successful closure of the audit.
The Moraiya manufacturing plant had completed the USFDA audit from February 6 to 15 earlier this year, with zero adverse observations.
Post the audit, the plant has received several product approvals, including the final approval to market Mesalamine delayed-release tablets in the US. Earlier this month, it received USFDA approval for an antibacterial injection from Levofloxacin for its Moraiya plant.
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