Novo Nordisk has had filling, packaging and prefilled device manufacturing in Clayton, NC for years. Now the Danish drugmaker is betting its manufacturing future on the site. It will spend $1.2 billion on its first-ever U.S. API plant there and double the site's employment by adding 700 jobs.
Allergan Monday said it was going to pull some of its eye drugs from the market because of a problem with particles shedding from the tube cap which led to a "small number of customer complaints." The small number is nearly two dozen, including 12 consumers who said they had a foreign object in their eye as well as one report of swelling and another of blurred vision.
Just days after the FDA hammered Mylan sterile injectable plants in India in a warning letter, the drugmaker has said it is expanding a recall of injected cancer meds it manufactures there for Pfizer.
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It has been more than 6 years since Caraco Pharmaceutical Laboratories was forced to suddenly shut two Detroit-area manufacturing plants after the FDA sent in marshals to seize drugs, claiming the plants had contamination issues. One of the plants was even closed last year by Caraco owner Sun Pharmaceutical. But legal problems continue to reverberate for Sun for having laid off hundreds of workers without notice.
When Shire shelled out $4.2 billion for ViroPharma a couple of years ago, it picked up the rare disease drug Cinryze, but what it didn't get in the deal was complete control over manufacturing of the rare disease drug. That had been ceded by ViroPharma to Sanquin Blood Supply. But Shire has now worked a deal with Amsterdam-based Sanquin that will allow it to add more contract manufacturers and so boost production of the treatment.
Sucampo sees a number of advantages to buying Japanese CDMO R-Tech Ueno, not the least of which will be owning the manufacturing for the two drugs that it sells.
The FDA publishes warning letters and inspection reports on its websites. It issues public recalls and drug label warnings. However, it is not feeling in such a sharing mood when it comes to its proposed letter grades for manufacturing plants on the quality of their manufacturing.
Sterigenics International, which counts vaccine and API sterilization among its irradiation services, is expanding.
Several years ago, GlaxoSmithKline sold off a portfolio of consumer products in the U.S. The drugmaker had indicated a plant in Memphis, TN, was going to be sacrificed as part of that decision but GSK still has the plant and is even planning to spend some money making improvements to it.
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