A Fresenius Kabi sterile manufacturing plant in New York that the FDA cited in 2012 after finding insects in some of the drug vials has earned a reprieve from the agency. The drugmaker said Tuesday that the FDA will allow the APP Pharmaceuticals plant to seek approvals for drugs manufactured there.
German drugmaker Fresenius Kabi's U.S. operation has completed the recall of half a million vials of drugs started more than two years ago because the glass had fractures and might contain particles.
Indonesia is one of those emerging markets that has pressured outside companies to produce locally and companies like Pfizer, Merck and Fresenius Kabi have all built or expanded plants there in recent years. But the government, which controls some of the players, is taking steps to improve efficiency in the domestic market, pushing for a merger that ties the manufacturing expertise of one company to the supply chain strength of another.
Planning to expand its production capacity in Russia and the former Soviet Republic, Germany's Fresenius Kabi agreed this year to partner up with Binnopharm, a Moscow-based drugmaker that has two manufacturing facilities making IV drugs, infusion solutions and active pharmaceutical ingredients, not unlike Fresenius. But the political situation in Russia has made that too difficult, so Fresenius and Binnopharm are exploring other ways to work together.
Building political tensions between Russia and the West are making it increasingly difficult for drugmakers in the region, prompting Germany's Fresenius to dump a partnership there. The announcement comes as other drug companies have reported their businesses are under pressure in the area.
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.