Manufacturing news in brief
pharmafile | June 8, 2010 | News story | Manufacturing and Production |Â Â AHP Manufacturing, Caraco Pharmaceutical, Hospira, KV Pharmaceutical, PharmalucenceÂ
The pharmaceutical manufacturing sector had another week of mixed fortunes, with yet more recalls being announced and a former Wyeth unit falling foul of waste regulations. On the positive side two generic firms made progress in setting their houses in order, and Pharmalucence has revealed plans to build a new facility in the US.
US specialty drugmaker Pharmalucence has said it plans to build a new 70,000-sq.-ft. production facility in Billerica, Massachusetts, creating between 25 and 30 new permanent jobs. The investment has been supported by a $20 million bond issued by state investment agency MassDevelopment. Pharmalucence produces eight drugs to treat cancers and heart disease. Construction on the new facility will begin this summer, said the firm, and it is expected to be operational by the end of 2012.
A subsidiary of Wyeth (now Pfizer) based in Ireland has pleaded guilty to various offences related to the improper export and disposal of pharmaceutical waste, according to a report in The Irish Times. AHP Manufacturing, trading as Wyeth Medica Ireland, used a contractor which was not licensed to handle hazardous waste, shipped materials without a certificate and mixed hazardous and non-hazardous waste together. The offences date back to 2000 and 2001 and concern the export of a waste by-product of the manufacture of medroxyprogesterone acetate, a component of contraceptive medicines. The case came to light when waste water from the plant was used in the production of animal feed, leading to infertility in thousands of pigs in the Netherlands.
KV Pharmaceutical has sold off its raw materials and ingredients subsidiary Particle Dynamics Inc to a private equity group for $24.6 million. The PDI sale is a key element of a recovery plan for the US drugmaker, which is trying to stay solvent after having manufacturing of products made by its Ethex subsidiary shut down for non-compliance with quality standards. KV Pharma’s interim president and chef executive David van Vliet said the move was in line with the company’s strategy of selling off non-core assets “to strengthen our financial position and improve liquidity”.
Hospira has expanded a recall of contaminated products, including Cleviprex (clevidipine butyrate) for hypertension and parenteral nutrition product Liposyn and the anaesthetic propofol, which is currently in short supply after quality problems caused Teva, another major US supplier, to bow out of the market. The firm has also been sent a warning letter from US regulator the FDA over contamination with particulate matter (sub-visible inert stainless steel particles) of the product, which are made at its Clayton, Ohio, and Rocky Mount, North Carolina facilities. The letter indicates some deficiencies are repeat observations from an inspection in 2009 which resulted in recalls of Liposyn and propofol in November 2009 and March 2010.
And finally Caraco Pharmaceutical, another company that has been struggling with GMP compliance problems, seems to be starting down the road to recovery after being granted FDA approval of a programme of improvements designed to get its production facilities in Detroit, Michigan, back online. Last year US Marshals working on behalf of the FDA seized active pharmaceutical ingredients (APIs) and finished products with an estimated value of around $20 million from the unit after a series of manufacturing quality violations.
Phil Taylor
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