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Manufacturing issues round-up

By Natalie Morrison , 26-Jan-2012
Last updated the 26-Jan-2012 at 13:45 GMT

in-PharmaTechnologist presents a round-up of issues within the pharmaceutical manufacturing industry, including Novartis’ plans to restart Nebraska ops and problems for Roche at it’s South Carolina facility.

Novartis will restart its closed OTC (over-the-counter) manufacturing plant in Lincoln, Nebraska, this year following a seven per cent hit in the sales division in its Q4 results.

The firm voluntarily suspended the facility this month, following a cutting US Food and Drug Administration report which fingered the company for poor QC (quality control).

At the time it also recalled several products produced in Lincoln, including Excedrin headache pills and NoDoz meds because of broken tablets, and mix ups with other products.

The shutdown has already come at a $200m (€152m) price tag, including a $115m charge for the closure and recalls. The plant is plant is also 25 per cent of the company's total worldwide OTC sales.

Now CEO Joseph Jimenez says he is confident the plant will re-open mid-year – a sentiment reflected in its 2012 revenue outlook on shipments, which factor in the Lincoln plant.
In a Q4 conference call, he said:

“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.”

Manufacturing issues at Roche’s South Carolina, US, facility mean that two drugs could soon be in short supple.

Shortages for the medication in question – Mircera, an anaemia drug, and weight loss treatment Xenical – would only affect some countries, and authorities have not demanded a recall.

The problems, which have not yet been specified, were discovered during a routine internal inspection.

The firm is now working with both US and European authorities to rectify matters.

A spokesman for the company told Reuters: "We don't expect any material impact on 2012 results.

"We're supplying the market with most of the products that are produced at the plant but there's a risk of a stock out in individual countries."

Abbot Laboratories has laid off 700 workers largely in manufacturing operations, with hundreds more due for the chop over the year.

The company says the looming end to its contract to supply Promus artery-opening stent to Boston Scientific group – which has decided to manufacture in-house – is a driving factor behind the move.

Scott Stoffell, corporate public affairs at Abbott, said orders for Promus have dipped ahead in anticipation of the contract expiration.

The restructuring costs, seen in the firm’s Q4 earnings results, show the firm stands to spend about $276m.

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