Walgreen last year decided to take on a more international frame of mind when it bought a 45% chunk of the Swiss drugstore chain Alliance Boots. Now the two have partnered with one of the largest supply-chain players to smooth out distribution and hopefully cut some costs.
As shortages of sterile injectables persist, the makeup of that part of the industry is in flux. Now that Mylan has agreed to buy Agila Specialties, the injectables unit of Strides Arcolab, for $1.6 billion, analysts think Claris Lifesciences could be next.
The agency this week ordered Med Prep Consulting of New Jersey to recall all of its products after 5 bags of magnesium sulfate intravenous solution were found to have mold. While there have been no reports of infections this time, and another 13 bags appeared to be free of contamination, the FDA said it was taking no chances.
Italy is the world's second largest producer of active pharmaceutical ingredients (APIs), trailing only China. It holds nearly a 30% share in the U.S., still the largest market for branded and generic APIs.
As plant problems drained away supplies of the important generic chemo drug leucovorin a few years ago, Spectrum Pharmaceuticals got to play the hero by upping production of its own branded version, Fusilev, or levoleucovorin.
API and drugmakers around the world who had eluded FDA oversight were expected to feel the heat after generic drugmakers kicked in new user fees that would help extend agency inspections around world. But a big piece of that money is being held hostage by the sequestration law.
Jordan-based Hikma has become the second largest player in the U.S. sterile injectables market by riding a wave of manufacturing woes that has washed over competitors. And while it struggles with problems at its own tablet manufacturing plant, its injectables business keeps on growing as competitors like Hospira continue to struggle.
One of the big challenges of slowing the flow of counterfeit drugs is its international nature. Fakes may be made in China, for example, and make stops in several continents before finding their way into the legitimate supply chain.
Ranbaxy Laboratories is overcoming hurdles as it tries to regain its vaporized market share for generic Lipitor. It got past a recall, figured out how glass particles got into its API and is again manufacturing the drug for the U.S. market. Now it has also squashed an effort to force a national recall of its past production of the drug.
GlaxoSmithKline is suing Hospira for more than $25 million in damages over the quality of influenza vaccine supplies for the U.S. market. In the lawsuit, GSK alleges that Hospira hit quality problems and cancelled the contract three years before it was due to end.