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Fresenius Kabi

Latest Headlines

Latest Headlines

FDA upgrades Fresenius sterile plant once cited for insect infestation

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.

Fresenius closes out recall started two years ago

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's Indofarma combines its manufacturing expertise with Kimia's supply chain strength

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.

Fresenius expansion plans in Russia sidelined by political turmoil

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.

Fresenius kills Russian partnership as political tensions escalate

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 receives FDA approval of three-chamber bag for parenteral nutrition

Fresenius Kabi announced Aug. 26 that it has received approval of the Kabiven and Perikabiven, parenteral nutrition products in a three-chamber bag.

Fresenius awaiting FDA reinspection at plants in NY, India

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.

Novo A/S-owned Xellia snaps up Fresenius vial plant to expand in U.S.

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.

Baxter adds saline production from Spain to U.S. supply

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.

FDA lets Fresenius import saline to help with shortage

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.