Novartis Suspends Production At A Key Plant

Novartis Suspends Production At A Key Plant

January 5th, 2012 // 1:37 pm @

Late last month, Novartis quietly suspended production at a plant in Lincoln, Nebraska, where various over-the-counter and animal health meds are manufactured. The drugmaker is calling the move a voluntary step that is being taken for “compliance improvement activities” and to “expedite maintenance and improvements and continue to strengthen standards.”

As a result, supplies of various popular over-the-counter products will be affected, including Excedrin, Theraflu, Triaminic, Maalox and Lamisil (read here). As for veterinarians, the popular Interceptor and Sentinel treatments for heartworm will also be harder to come by (see this). A Novartis spokeswoman was unable to say how long the shutdown will occur or whether the action was precipitated by regulatory inspections.

It is worth noting that Novartis received a November 18 warning letter for “significant violations” at two plants in the US – Broomfield, Colorado and Wilson, North Carolina – and another in Boucherville, Quebec, in Canada, which make prescription drugs for humans. And several of the various infractions were actually repeat offenses (back story).

As we have reported previously, the FDA is trying to get tough on manufacturing issues and would appear to be examining Sandoz for systemic problems, especially given that the letter was sent to Novartis ceo Joe Jimenez in Switzerland. Now, though, the move to upgrade the Nebraska plant for compliance issues suggests that an even broader overhaul is under way.

We asked the Novartis spokeswoman for additional details on the full menu of meds affected and the extent to which regulatory oversight played a role in the shutdown. We will update you accordingly when we receive a response. [UPDATE: A Novartis spokesman sends us a statement that says: “These actions have been communicated to the (FDA). We are working closely with the agency and our customers and will continue to do so throughout this process,” but no further details were offered concerning regulatory interactions or when production would resume.]

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