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Theqmnweeklybulletin

March 7, 2008

Vol. 2 No. 10

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FDA Finalizes Stability Testing Protocol Guidance

Manufacturers of sterile products that test for container and closure system integrity in stability protocols, rather than for sterility, need not validate the tests for individual products that share the same type of container if they follow the FDA’s new guidance. Read More

Fentanyl Patches With Reservoir Design Recalled

Two drugmakers recently recalled their fentanyl transdermal patches due to concerns that the pain medicine contained in the patch could leak into the packaging, potentially causing serious adverse events such as fatal overdose and respiratory depression. Read More

Expert: Don’t Let eMails Derail Proactive Recall Plans

Although manufacturers may not anticipate conducting a recall, companies should take a proactive approach to make sure they are recall-ready, an expert advises. Read More

Nycomed to Build a Pharmaceutical Plant in Russia

International pharmaceutical company Nycomed started the search of a site for the construction of its pharmaceutical plant in Russia. Read More

Reliance Plans Pharma Unit in Jamnagar

Reliance Life Sciences (RLS) plans to set up an active pharmaceutical ingredients (API) and formulations manufacturing complex at Jamnagar. Read More

Teva Sprints Ahead of the API Field

With active pharmaceutical ingredient sales of $1.46 million in 2007 and a portfolio of more than 250 compounds, Teva Pharmaceutical Industries is by a long stretch the dominant supplier in the global API market. Read More

Hovione Buys Drug Manufacturing Facility in China

Hovione announces that it has purchased 75 percent of Hisyn Pharmaceutical Co. Limited. Read More

New Development Center and Aseptic Facility Open Near Baltimore

Pharmaceutics International has opened a new 30,000 sq. ft. state-of-the-art development, aseptic filling facility and cGMP manufacturing plant near Baltimore, Md. Read More

Fresenius to Invest in Production of Dialysis Components

Fresenius Medical Care said it plans to invest [approximately $59 million] to expand production capacity for dialysis machine components at its plant in St. Wendel, Germany, over the next 12 months to meet the rising demand for artificial kidneys. Read More