The QMN Weekly Bulletin

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.

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.

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

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

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

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.

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

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.

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.