FDI Inspects Wockhardt’s Manufacturing Facility

FDI Inspects Wockhardt’s Manufacturing Facility

Wockhardt, India’s leading pharma company, informed that US Food and Drug Administration has made “observations” in its establishment inspection report for the company’s units in Maharashtra.

The FDI report on the manufacturing facilities does not recommend any change in the US Ban for importing from the company. With this report is also got clarified that the ban to United States from this facility will continue. “Receipt of the report does not change our existing status for the units concerned. It does not materially change the status of an import alert for the units concerned for the US market,” Wockhardt said.

Reacting to the news, Wockhardt’s shares slumped nearly 5 per cent on the bourses. On the BSE, the stock, which had opened marginally higher at Rs 1,077.70, hit a low of Rs 980 – a drop of 5.54 per cent – and thereafter, closed at Rs 991.15, a drop of Rs 46.35, or 4.47 per cent.

Suven Life Scieneces gets FDA inspection report

On the other hand, US FDA has also issued an Establishment Inspection Report for Suven Life Sciences’ facility at Pashamylaram, near Hyderabad. The company had undergone USFDA renewal inspection at the facility that manufactures and supplied active pharmaceutical ingredients (bulk drugs), intermediates and formulations under Current Good Manufacturing Practice (CGMP) in April this year, according to a statement from Suven. Based on the inspection and review thereafter, the regulator had concluded that the inspection is “closed” and on July 15 issued the EIR. Suven so far has filed 19 DMF’s and four ANDA from the facility which is FDA complaint under CGMP and continued after renewal inspection.