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Cadila Healthcare Ltd informed the stock exchanges today that the US Food and Drug Administration had found the company’s facilities at Moraiya “acceptable”.
The US FDA had in June 2011 issued a warning letter to Cadila, citing non-conformity of the facilities with the US FDA norms.
“These violations cause your drug products to be adulterated,” the US FDA had then said.
“We are concerned that trained microbiologists employed by your firm were unable to accurately identify microbial growth on environmental monitoring plates. Additionally, there is no assurance that such errors have not occurred previously (during the manufacture of exhibit batches for application products pending with FDA),” the US regulatory had then said.
It had expressed concerns over that the procedures for keeping the manufacturing area completely sterile. “We are concerned with the fact that operators performing critical operations may not be adequately monitored,” the ‘warning’ letter said, cautioning Cadilla that if corrective measures were not taken immediately, the company’s products may not be allowed to be sold in the United States.
On the BSE today, the share price of Cadila Healthcare rose over Rs 33 (over 4 per cent) and is currently trading around Rs 832.
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