Serious Problems At Novartis Plant in Austria, Too

Serious Problems At Novartis Plant in Austria, Too

May 7th, 2012 // 12:53 pm @ jmpickett

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Over the past few months, Novartis has struggled with a string of problems at several manufacturing plants. Notably, a facility in Nebraska suffered embarrassing gaffes involving over-the-counter meds and animal health drugs (see this and this). And the FDA sent a warning letter last November for “significant violations” at two other US plants – Broomfield, Colorado and Wilson, North Carolina. A Sandoz plant in Quebec, Canada, meanwhile, has since halted some production.

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However, the drugmaker is having an equally rough time in Europe, where shortages are reported in several countries, including Austria, Belgium, Bulgaria, Czech Republic, Germany, Spain, France, Hungary, Ireland, Italy, Netherlands, Poland, Portugal, Romania, Slovenia and Slovakia, according to Polish media (read this).

A Novartis spokesman writes us that “the current situation was caused by a combination of factors, including significantly increased global demand as well as multiple manufacturer shortages at several companies around the world. Sandoz and other suppliers of generic oncology injectables have not been able to ramp up supply sufficiently to compensate for these two factors, leading to an industry-wide supply shortage affecting several countries around the world” (here is the FDA shortages list, where Sandoz appears several times).

However, the problem has been exacerabated by ongoing problems at a facility in Austria, which is home to a generic injectables business, the former Ebewe, that Novartis purchased for $1.3 billion three years ago (look here). Since then, the Sandoz unit has been “constantly upgrading” and “as a result of that, there are still problems in their production facilities,” according to this report. At the time of the acquistion, Sandoz emphasized that a key priority was to capitalize on the “expertise in injectables manufacturing” demonstrated by Ebewe.

The Novartis spokesman acknowledges that work is under way, but declined to be specific about the problems. “In order to meet the highest quality standards, Sandoz is strengthening operations at its Austrian site by implementing equipment and process upgrades,” he writes us. “This has required us to temporarily slow down production at the site, thereby limiting our ability to fully meet our supply commitments” (here is a list of shortages in Austria).

The issues at the Austrian plant, however, are not just causing shortages. Last month, the Lebanese Health Ministry banned one Sandoz drug, Carboplatin, due to several instances in which a degeneration was detected 15 months or more after it was manufactured, according to The Daily Star.

Taken together, it becomes increasingly clear why Novartis ceo Joe Jimenez recently named managers to clean up the various messes around the globe. Notably, Ivan Moller was named head of GMP manufacturing and quality program management to a group-level ‘Program Management Function’ for handling companywide remediation activities and form a single quality program. And Didier Colombeen was named head of global manufacturing and supply, which involves running all aspects of manufacturing operations and the supply chain. She succeeds Cath Malseed, who left Novartis