Pharma manufacturing news in brief
pharmafile | January 21, 2011 | News story | Manufacturing and Production |Â Â Cambrex, Faron Pharmaceuticals, McNeil Consumer Healthcare, NextPharma Technologies, Rentschler Biotechnologie, Sandoz, ShangPharma, Sun European Partners, Teva Pharmaceuticals USA, Unilife CorpÂ
Another J&J recall in the US, plus a round-up of product recalls, acquisitions, facility updates and new contracts in the pharmaceutical manufacturing arena.
Johnson & Johnson subsidiary McNeil Consumer Healthcare has initiated yet another recall of over-the-counter medicines, this time involving Tylenol 8 Hour, Tylenol Arthritis Pain, and Tylenol upper respiratory products, and various lots of Benadryl, Sudafed PE and Sinutab products distributed in the USA, the Caribbean, and Brazil. These products were manufactured at McNeil’s plant in Fort Washington prior to its shutdown last April because of quality control problems. The recall has been initiated after a review of production records found that the batches may have been produced using improperly cleaned equipment.
In other US recall news, Novartis’ generics subsidiary Sandoz has pulled almost three million bottles of 50mg and 100mg metoprolol tartrate tablets, because the batches may have been subject to variable granulation during production which affect the active ingredient’s characteristics. Meanwhile, Boehringer Ingelheim Roxane has recalled around 12,000 bottles of 1,000mg valacyclovir HCl tablets, 1 gram in 30-count bottles because of stability failures on dissolution testing, and Teva Pharmaceuticals USA has recalled 460,000 vials of oxytocin injection (10 units/1ml and 100 units/10ml) which may not meet impurity specifications through their expiry date.
Private equity firm Sun European Partners has entered into an agreement to acquire UK contract manufacturing and development service company NextPharma Technologies. The UK firm has seven manufacturing facilities, seven product development units and six temperature-controlled storage and distribution sites across Europe and the USA. In a statement, Matthias Gundlach, vice president of Sun European Partners, said: “We see significant opportunity to grow the business both organically and by acquisitions.” Terms have not been disclosed.
Contract manufacturing company Cambrex has been granted approval in Europe for its new Cambrex Zenara facility in Hyderabad, India, following an audit by the Danish health authorities. The new site will supply nicotine replacement products such as chewing gums, lozenges and mini-lozenges for customers including Johnson & Johnson, which sells nicotine-based smoking replacement products under the Nicorette brand.
Chinese outsourcing company ShangPharma has started production at its new facility in Fengxian in the suburbs of Shanghai. The plant will offer process R&D, formulation R&D, analytical method development and validation, and GMP manufacturing of intermediates and active pharmaceutical ingredients. ShangPharma will now be able to support projects in phase II and III development, whereas before it could only handle early-stage production support. The new unit houses a pilot plant, six reactor suites, two cleanrooms and an R&D laboratory.
Faron Pharmaceuticals has commissioned Rentschler Biotechnologie to manufacture its interferon beta-1a-based drug Traumakine (FP-1201), which is due to start pivotal trials in the prevention of vascular leakage in patients with acute lung injury andacute respiratory distress syndrome next year.
Unilife Corp of the USA has completed construction of its $31 million manufacturing plant and corporate headquarters in Philadelphia, and plans to start producing medical syringes there by the end of March Around 150 workers are already on-site and that number should swell by 250 or more by the end of 2012. The plant has the capacity to make 400 million syringes a year and could in time be upgraded to reach a billion-unit capacity.
Phil Taylor
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