Novartis says Nebraska plant to reopen midyear

The Novartis ($NVS) Nebraska plant closed in December because a host of over-the-counter products contained stray pieces from other drugs is expected to reopen this summer.

Twice in recent days officials with the Swiss company said manufacturing problems that led to a January recall of Excedrin and other products were being addressed and that the Lincoln plant should reopen midyear.

CEO Joseph Jimenez included sales from the plant in his guidance for 2012 during a conference call with investors, reported In-Pharmatechnologist.com.

"We have people in the site right now working on remediation," he said. "We wanted to put an assumption into our guidance that we felt that we could deliver upon. So I'm fairly confident that we can do this."

Then in a statement emailed to FiercePharmaManufacturing today relating to reports that the company had released, temporary worker's spokeswoman Julie Mascow said: "Novartis Consumer Health is actively working toward a plan to resume manufacturing operations at the site and expects to start shipments midyear."

"We do not expect the temporary suspension in production to impact employees. However, we've had to release some of the temporary workers. Approximately 40 temporary workers are currently being retained to work in manufacturing and packaging," she continued.

Novartis set aside $120 million to address the issues. The shutdown not only cost Novartis time, sales and reputation, it has affected Endo Pharmaceuticals ($ENDP), which had the Opana ER painkiller and other analgesics produced there.

Pharmalot reported today that a new FDA inspection report, which includes inspections from Dec. 14 through Jan. 20, suggested that problems are ongoing. The report also pointed out that Novartis only recently got around to notifying veterinarians that the same potential problems could affect a drug used to treat dogs for separation anxiety.

A Novartis spokesman wrote FiercePharmaManufacturing to say that while there was only a rare chance of a problem, it notified vets out of an abundance of caution.

- get the the In-Pharmatechnologist story
- here's the WOWT.com report
- read the Pharmalot story
- here's the inspection report (.pdf)

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