The QMN Weekly Bulletin

The European Commission (EC) is proposing to expand its regulations on good manufacturing practice (GMP) inspections by allowing member states to conduct both announced and unannounced audits of active pharmaceutical ingredient production facilities.

Three Boston Scientific cardiovascular products are ready to be launched this year if a 2006 corporate warning letter is lifted.

Following Stryker’s recall and temporary production stoppage of artificial hip components, growth in the company’s hip franchise is expected to slow in the first quarter.

The U.S. Food and Drug Administration (FDA) has revealed evidence linking the heparin contaminant with the series of reported adverse reactions, and has also now issued a warning letter to the Chinese facility at the center of the safety scare after completing its inspection.

Federal inspectors documented unwanted "fibers" on the stoppers of vaccine vials at Merck & Co. Inc.'s vast vaccine plant in Montgomery County.

A $30 million expansion of Birmingham's Brookwood Pharmaceuticals will allow the drug-delivery company to add manufacturing of final products to its research and development work, another boost for the state's burgeoning biotechnology sector.

Schott AG and Kaisha Manufacturers Private Ltd., an Indian company, announce the formation of a joint venture, Schott Kaisha Private Ltd. The new joint venture will manufacture primary pharmaceutical packaging made of glass for the Indian market.

Four years ago, Synovis Life Technologies Inc. hired Richard Kramp to resuscitate its ailing interventional business, which made components for other medical device firms.

Singapore's March factory output fell less than expected from February, despite poor exports to key markets, but economists cautioned that weakening demand may hit the trade-dependent country later in the year.