Novartis Dumps OTC Drugs Produced at 483-Plagued Nebraska Plant

Novartis Dumps OTC Drugs Produced at 483-Plagued Nebraska Plant

May 2nd, 2013 // 2:47 pm @

Updated Daily – Read our latest FDA, cGMP Compliance News

As part of the plan to reduce manufacturing operations at its 483-plagued plant in Lincoln, NE, Novartis sold the rights in the US to six of its OTC drugs. Five of them were produced at the troubled plant in Nebraska. The sale was made final in March and was done just as the firm is undergoing a major review of its OTC drug portfolio. This is due to a long period of weak sales due to serious manufacturing problems and cGMP violations.

The products that Novartis unloaded were:

  • Comtrex cold reliever
  • Doan’s pain pills
  • Myflex anti-pain cream
  • Nupercainal hemmorrhoid cream
  • Cruex anti-fungal cream

All of these except Cruex were made at the plant in Nebraska. The drugs were bought by Duchere Pharma.

This move to unload these drugs also shows a larger restructuring is being done at Novartis. The company stated last week that it only will make three drugs at the Nebraska plant now – Excedrin headache pills, Theraflu flu remedy and a heartworm pill for pets named Sentinel. 300 jobs have been lost at the NE plant.

Novartis has noted that they have had almost 60 inspections by various health regulatory agencies in the last quarter. Ten of them were by FDA. Most of the inspections were either good or satisfactory. However, the firm did not note how many inspections had cGMP violations nor did they discuss any 483 observations noted. The Nebraska plant had a recent 483 that was just made public by FDA, which shows the problems there are far from over.

Novartis has had serious manufacturing problems at many plants in the last 24 months. The Novartis CEO went so far as to publish a memo that stated to employees how important quality is. If you’re having to remind employees in a drug company about the importance of quality, we don’t take this as a great sign!

The Novartis OTC business has suffered a good deal from the Nebraska problems. Sales did increase by 6% to $980 million in Q1, but that only looks good when compared to a weak year in 2012. Looks like Novartis could stand to benefit from our great Webinar on how to survive an FDA audit!


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