About three months before Hospira closed on its acquisition of an API plant from India's Orchid Chemicals & Pharmaceuticals, FDA inspectors made a visit to the facility in Waluj. They had concerns with what they found.
A loose hair has again tripped up Hospira, which is voluntarily recalling one lot of heparin as a result.
When the sterile injectables plant Hospira is building in Vizag, India, opens, perhaps yet this year, the company expects the 1.1-million-square-foot manufacturing facility to add capacity at a lower operating cost. But a plant of that size requires a lot of workers, and so Hospira is also making plans to train the people it needs there.
Hospira's reprieve from generic Precedex competition was short-lived. The U.S. district court that temporarily stopped Precedex generics has now decided to let the copycats roll. And that could mean Hospira will soon be sharpening its job-cutting ax.
Many a U.S. drugmaker has pounced on an opportunity to pick up a foreign company, haul overseas and reap the tax rewards. But while rumors this summer said Illinois-based Hospira would be jumping on the tax-inversion bandwagon, its deal isn't moving quite so quickly.
Lawsuits against the FDA don't normally get much traction. Luckily for Hospira ($HSP), it has one that did. A federal judge has suspended the agency's decision allowing drugmakers to market certain generic copies of Hospira's top product--but it won't recall the copies that are already out there.
New generic competition in the U.S. always makes a sales organization uneasy because layoffs usually follow. But Hospira's branded sales team faces a double whammy.
The launch of a generic of a key product in the U.S. always makes a sales organization uneasy because it inevitably means layoffs. But the last thing any sales team wants to hear is that its boss will have to lay off pretty much everyone if a generic comes to market. Yet that is what Hospira told a court is in store if it doesn't block copies of its sedative Precedex.
Amid growing regulatory action to crack down on corporate tax inversions, a top U.S. senator is urging Hospira to keep its operations at home and abandon plans to move abroad for taxpaying purposes.
Hospira's long troubled Rocky Mount, NC, manufacturing plant is troubled no more. CEO F. Michael Ball says a much anticipated reinspection of the plant by the FDA resulted in no observations. But now the FDA's focus has shifted to a new plant in India where manufacturing issues have caught its attention.