Boston, MA 05/06/2014 (wallstreetpr) – Hospira, Inc. (NYSE:HSP), an injectable drugs and infusion technology provider, believes its new specialized injectables plant in Vizag, India, will commence operations this years despite issues that have been raised by the U.S. Food and Drug Administration over the facility.
Hospira, Inc. (NYSE:HSP) has in recent past suffered in the hands of the FDA over plant problems. However, it has got many of the problems behind and expects the remaining issues to be resolved quickly and without financial or operational performance impact.
Its absence from the market due to plant problems has given a field day to rivals, but the company expects to not only reclaim its market share but also significantly expand market share for its products and improve revenue. The company seeks to aggressively create value for the shareholders that have been patient with the company through the hard times.
FDA Form 483
The pre-inspection of the Vizag facility in India where Hospira, Inc. (NYSE:HSP) expects to manufacture specialized injectables, led to a Form 483 from the FDA. The form observed 10 issues with the plant. Though that came as a setback for the company given that it intended to commence operations at the plant by the end of this year, the company said that all is not lost.
In any case, it said that only five of the 10 issues raised are new because it had already identified five issues with the facility and was in the process of addressing them. It will, therefore, address all the 10 issues in good time to ensure that the facility gets approval for operation before 2015.
The issues raised in the 1.1 million sq ft facility in Vizag touch on supplier quality and training. According to CEO Michael Ball, the company is equipped to effectively address the issues without delay.
1Q2014 performance
Hospira, Inc. (NYSE:HSP) realized sales of $1.05 billion, an increase of 19 percent on a year-over-year basis. The bottom-line also improved by almost a similar margin to $101 million. The company promised improved performance once it gets its two Indian facilities online and addresses problems at the Rocky Mount facility in the U.S.
