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Sunday, August 18, 2013

Wockhardt says one more unit under FDA scanner

This story first appeared in DNA Money edition on Thursday, Aug 15, 2013.

Pharma major Wockhardt’s regulatory troubles over its manufacturing facilities do not seem to end.

After its Waluj unit in Aurangabad,  foreign regulators have  expressed concerns over its the largest revenue contributing unit of Chikalthana in the same district.

According to a senior Wockhardt official, both US Food and Drug Administration (FDA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) had conducted inspections at its Chikalthana, Shendra and Waluj Cephalosporin plants in July.

“The Chikalthana plant was jointly inspected by USFDA and MHRA in the last week of July and they have raised observations. We have 483s, some of them are more serious and some are minor in nature. We are reviewing all the questions and observations and will respond to the FDA next week,” the official said on an earnings call.

No critical observations were recorded by the MHRI for Wockhardt’s Shendra plant that caters to the UK, Irish and the US markets. The USFDA is expected to inspect the Shendra facility next month. The inspections by the regulators at its Waluj Cephalosporin plant were satisfactory, said the official.

For fiscal 2013, the Chikalthana facility contributed $230 million to the company’s sales.

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