The QMN Weekly Bulletin

The FDA, industry and Congress all support draft legislation to increase funding for more inspections of foreign manufacturing facilities, but agency officials and lawmakers differ on whether such inspections should be required every two years or prompted by risk-based analyses.

Merck’s bulk drug substances used to manufacture many of its vaccines are adulterated, and the FDA is requesting a meeting with senior management to expedite the firm’s corrective actions, according to a recent warning letter.

Catalent Pharma Solutions failed to follow appropriate procedures to ensure its drug products are sterile, according to an FDA warning letter.

The Canadian HIV/AIDS Legal Network welcomed announcement that Rwanda’s government, after a competitive tendering process, has chosen to purchase a low-cost AIDS drug from Ontario-based generic pharmaceutical manufacturer Apotex, Inc. - meaning that Canada’s Access to Medicines Regime should soon deliver for the first time on its promise of affordable medicines for developing countries.

Swedish materials and engineering giant Sandvik has acquired Sheffield-based orthopaedic instruments and implants business Eurocut.

Jubilant Organosys Limited, an integrated pharmaceutical industry player and [a] custom research and manufacturing services company in India, announced that it had acquired 100 per cent stake in Speciality Molecules Limited, a niche manufacturer of Speciality Intermediates with manufacturing facilities located at Ambarnath. …

Three labourers died in the Wockhardt Pharmaceuticals Company premises after being hit by a stopper of a storage vessel on Monday afternoon in Ankleshwar GIDC (Gujarat Industrial Development Corporation) estate.

The PPF Group has launched a takeover attempt on the Czech Republic’s largest generic-drug manufacturer, Zentiva.

Jumping on the environmental bandwagon, Millipore Corp. plans to unveil a promise to cut its greenhouse gas emissions by 20 percent over the next five years.