USFDA audit finds no flaws in Cadila Healthcare Moraiya unit

Plant has received several product approvals after audit. eyes 40 in all in FY18

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. 

As such with regulatory issues getting sorted, the drug maker expects to get as many as 40 approvals for the US market during FY18, which currently contributes to around 40 per cent of its revenues. 

The Moraiya plant, which contributes around 60 per cent of its US sales, was served a warning letter in December 2015. This led to delays in product approvals and cut in earning estimates.