Novartis will restart production at Lincoln plant in May
pharmafile | May 1, 2012 | News story | Manufacturing and Production | FDA, GMP, Lincoln, Nebraska, Novartis, manufacturing
Novartis chief executive Joe Jimenez has said that production at the firm’s troubled consumer health plant in Lincoln, Nebraska, will get underway later this month with a view to resume shipments of key product lines mid-year.
The ramp-up of production will be slower than expected, however, and some of the product lines made there will not be available through the end of 2012 and others will be discontinued altogether, he added.
A temporary shutdown of the Lincoln plant because of Good Manufacturing Practice (GMP) violations in early January resulted in significant supply shortages for some of the company’s biggest-selling over-the-counter medicines, including items in its Excedrin painkiller range, and cost the firm $200m in the first quarter in lost sales and remediation costs.
“We are in the middle of quality remediation activities at Lincoln, and we’re making good progress,” said Jimenez, adding that Novartis recently had a meeting with the FDA and presented its start-up plan for the plant.
The relatively slow process of resuming production means that Novartis will still have “a relatively limited portfolio in the back half of the year”, he noted, adding that Novartis will try to accelerate the recovery process by signing over production of some key product to contract manufacturing organisations.
Novartis is also taking the opportunity afforded by the shutdown to review the number of stock-keeping units (SKUs) for products made at Lincoln, and will eliminate some of those SKUs which are not performing as well as others.
“We’ll come back with fewer SKUs, but they will be stronger SKUs,” said Jimenez. “We’ll make sure that we have a very powerful line-up – all based on consumer preference – and that we’re not going to reduce volumes ” said Jimenez.
Sandoz sites
Meanwhile, Novartis’ chief executive also said the firm is making progress with the remediation of three North American manufacturing sites operated by generics subsidiary Sandoz, which were the subject of an FDA warning letter towards the end of 2011.
Production is continuing at all three sites – Boucherville in Quebec, Broomfield in Colorado and Wilson in North Carolina – while the company is upgrading the infrastructure and processes, and it is expecting re-inspections by the FDA before the end of the year.
Novartis has also been reshuffling management in its US operations, with Pharmalot reporting that OTC division head Naomi Kelman has been replaced by Brian McNamara after a little over a year in the post, while Cath Malseed has stepped aside as head of global manufacturing and supply to be replaced by Didier Colombeen.
In addition, Thorsten Hartig has been brought in to head up manufacturing at the division, while Ivan Moller has been placed in charge of the ongoing remediation efforts.
Phil Taylor
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