Fresenius Kabi announced Aug. 26 that it has received approval of the Kabiven and Perikabiven, parenteral nutrition products in a three-chamber bag.
Having racked up several warning letters over the past few years, Fresenius Kabi is now optimistic that two of its affected plants are getting back on track. Further progress is dependent on FDA inspectors visiting the plants in Grand Island, NY, and Kalyani, India, but with the agency dealing with failings at multiple companies, Fresenius thinks it might be a while before the regulator visits.
The deal gives Xellia capacity in North America for the first time, providing the company with a platform from which to realize the mid-term growth opportunities envisaged by Novo A/S when it bought the company.
The FDA, trying to help face down a national shortage of saline in the U.S., is for the second time allowing a manufacturer to import product from a plant in Europe that is not approved for the U.S. market, permitting Baxter International to ship from a plant in Spain.
The FDA has been scrambling for months to help relieve shortages of some common products used in U.S. hospitals, including saline solution and nitroglycerin. To do that it has been looking for some overseas suppliers that can kick in extra capacity, and it now says it has found one to get more saline into the U.S.
Germany's Fresenius Kabi has a grant from a state government in Australia and plans to build a new manufacturing plant there.
German drugmaker Fresenius Kabi punished a U.S. wholesaler this year after it mistakenly sold its anesthetic propofol to the state of Missouri, which intended to use it for executions. Missouri has agreed to return the drug after the Louisiana-based firm pleaded to authorities.
Just weeks after the FDA savaged a cancer drug plant in India for lying to investigators and hiding test results, it has received yet another warning letter, this time for problems at a Puerto Rico blood bag manufacturing facility.
An FDA warning letter to Indian drugmaker Posh Chemicals says that a quality-control chemist admitted during a March inspection that he "had recorded false visual examination data in the logbooks for reserve samples" at the order of a manager.
The generics division of the German healthcare company has bought controlling interest in Indonesian drugmaker PT Ethica Industri Farmasi from PT Soho Global Healthcare. The two will build a $60 million plant to make IV generic drugs and infusion solutions and make Fresenius Kabi the market leader in IV generics in Indonesia.