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Nov. 11, 2011

Vol. 3 No. 45

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FDA Warns UK GSK Subsidiary Over cGMP Violations

The FDA warned SmithKline Beecham, a UK subsidiary of GlaxoSmithKline (GSK), for inadequate aseptic procedures and other cGMP violations. Read More

FDA Warning Letter Prompts Closure of HIV Test Kit Maker

OraWell USA, a short-lived devicemaker specializing in in vitro diagnostic test kits for HIV detection, has shut down after an FDA warning that its test kits were not cleared and its manufacturing processes violated GMPs. Read More

Teva’s California Plant Back to Full Operation by May

Teva Pharmaceutical’s Irvine, Calif., plant is on pace to resume full manufacturing by next spring, the company says. Read More

JCM Passes Internal Quality Assessment for Azithromycin API Production

Tianyin Pharmaceutical announced that following the initial phase of operation, the Jiangchuan Macrolide Facility has passed the internal quality assessment for its first batch of production of Azithromycin API. Read More

AMRI Strikes Supply, Manufacturing Deal With Revolymer

Albany Molecular Research has signed a three-year supply and manufacturing agreement with Revolymer, a technology development company in the UK. Read More

Bosch Packaging to Open Second Production Plant in China

Bosch Packaging has started work on a second production facility in Chengdu, China to increase manufacturing capacity. Read More

Ancor Buys WellSpring Pharmaceutical

Ancor Capital Partners acquired WellSpring Pharmaceutical. Read More

Teva Planning to Cut 1,500 Jobs at Cephalon

Teva is reportedly planning to lay-off up to 1,500 staff at Cephalon, less than a month after it acquired the U.S. biopharmaceuticals firm. Read More

J&J Is Short of Cancer Drug Doxil

Johnson & Johnson is warning doctors not to start new patients on its cancer drug Doxil due to a supply shortage — the latest in a series of shortages from various drug makers that have hamstrung health-care providers. Read More