Nov. 11, 2011 | Vol. 3 No. 45
The FDA warned SmithKline Beecham, a UK subsidiary of GlaxoSmithKline (GSK), for inadequate aseptic procedures and other cGMP violations.
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.
Teva Pharmaceutical’s Irvine, Calif., plant is on pace to resume full manufacturing by next spring, the company says.
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.
Albany Molecular Research has signed a three-year supply and manufacturing agreement with Revolymer, a technology development company in the UK.
Bosch Packaging has started work on a second production facility in Chengdu, China to increase manufacturing capacity.
Ancor Capital Partners acquired WellSpring Pharmaceutical.
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.
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.
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