Nov. 18, 2011 | Vol. 3 No. 46
The FDA warned SmithKline Beecham, a UK subsidiary of GlaxoSmithKline (GSK), for inadequate aseptic procedures and other cGMP violations.
Devicemaker Rocket Medical failed to maintain adequate design controls and committed other GMP violations, the FDA alleged in a warning letter.
Recent positive regulatory inspections of Genzyme’s new Framingham, Mass., facility are lifting hopes that the agency will approve the plant in the first quarter of 2012, and in the meantime allow for additional sales of the company’s Fabry disease drug Fabrazyme, the drugmaker says.
Bayer HealthCare announced it is selling part of its site in Mishawaka, potentially putting nearly 300 people out of work.
Tough economic conditions, global competition, and regulations that increase chemical producers’ environmental responsibilities are prompting pharmaceutical manufacturers to eliminate waste in their manufacturing processes.
Intellipharmaceutics International announced that its Toronto-based oral solid dosage forms manufacturing facility has completed a cGMP and pre-approval inspection process by the U.S. Food and Drug Administration and has been granted “acceptable” status under the Agency’s strict regulatory guidelines.
China’s State Food and Drug Administration will start inspecting overseas production plants importing products and materials into the country this month.
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.
Par Pharmaceutical said it has completed its acquisition of privately-held Anchen Pharmaceuticals, a specialty pharmaceutical company focused on developing and commercializing extended release and niche generic products.
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