Allegations of company engaging in illicit production practices.
By The American Bazaar Staff
NEW DELHI: Generic drug manufacturer Wockhardt Ltd. has come under the microscope of the US Food and Drug Administration (FDA), which has alleged that the US manufacturing unit of the Mumbai-based company may be engaging in illicit production practices.
The news, which comes from Reuters, is another blow to Wockhardt, which had its two Indian plants suspended from exporting to the US last year after similar allegations surfaced about the manufacturing standards at the two plants. The plant in question this time is subsidiary Morton Grove Pharmaceuticals’ unit in Chicago.
Wockhardt reported fourth quarter profits 78% lower than their projections, a direct result of the FDA investigations. For the entire 2013-2014 fiscal year, profits were down by 47%, causing investors and shareholders to re-evaluate their stakes in the generic drug giant.
The Morton Grove facility was inspected by the FDA in March, after which the federal agency sent the company a standard notice citing various issues that it had with production practices at the plant. If the Morton Grove Pharmaceuticals plant does not come up to standards by a certain deadline, then drugs produced there will be disbarred from retail in the US.
Speaking to Reuters, Wockhardt Managing Director Murtaza Khorakiwala allayed fears of growing problems for the company, saying that the March inspection was basically routine, and that it was not overly negative in any way. He also said that Wockhardt is complying with the FDA as best it can.
After its Chikalthana and Waluj factories were stopped from shipping to the US, the company’s biggest market, last year, Wockhardt became just the latest in a growing list of Indian drug companies that the FDA has gone after for using unsafe and unsanitary practices at their facilities.
Most recently, Sun Pharmaceutical and Ranbaxy, among others, have had plants shut down by the US agency over such practices, hurting not only business for the respective firms, but also ties between the US and India.
Founded in the 1960s, Wockhardt is one of the biggest drug companies in India, with nearly 8,000 employees worldwide and offices and facilities in countries such as the US, UK, France, and Ireland.