Manufacturing facility news in brief

pharmafile | September 14, 2009 | News story | Manufacturing and Production BMS 

Pharmafocus' round-up of manufacturing facility news includes plant disposals by BMS and Sanofi-Aventis, a new build for device company Haselmeier and compliance updates from Apotex and KV Pharma.

In Australia, Sigma Pharmaceuticals is buying a manufacturing facility in Noble Park, Victoria from Bristol-Myers Squibb for A$60 million ($52 million) in a deal which also include marketing rights for several of the US drug major's products. In a statement, Sigma said the brands – which include the cholesterol drug Pravachol (pravastatin) – have annual sales of around A$33 million while the plant also brings in contract manufacturing revenues of A$17 million.

Haselmeier, a Swiss manufacturer of auto-injection pens, has started to build a 3,000 sq.m. facility in the Czech Republic that will bring increased capacity to assemble its devices. The plant is scheduled for completion in November and will employ 90 staff. Haselmeier helped develop a new pen for insulin therapy that was launched by Berlin Chemie and Menarini at the start of 2009 under the BerliPen areo 2 brand.

The US Food and Drug Administration (FDA) has placed all finished form drug products made at two manufacturing facilities operated by Canadian drugmaker Apotex under an import alert, in the wake of a June 25 warning letter that cited serious good manufacturing practice (GMP) deficiencies. The import alert covers products manufactured at Ontario facilities in Etobicoke and North York.

B>Sanofi-Aventis is closing a manufacturing facility in Kansas City, US, which employs 370 staff. The drugmaker said that declining demand for products made at the plant, which include its anti-histamine product Allegra-D (fexofenadine and pseudoephedrine), was behind the decision. Shutting down the unit will take around two years to complete.

Generic drugmaker KV Pharmaceutical is starting to resume limited production at its troubled manufacturing plant in St Louis, US, which was shut down as a result of good manufacturing practice (GMP) compliance problems in January 2009. Non-commercial batches of medicines are being made as the company tries to set the plant back on track, with the help of GMP specialists Lachman Consultant Services. The FDA will have to re-inspect the plant before full production can resume, but KV said it is hoping to be back in business by the end of the year.

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