View Cart  
Theqmnweeklybulletin

Sept. 9, 2011

Vol. 3 No. 36

View Archived Issues

Sign Up Now

BBC Biochemical 483 Notes Sterilization Procedures

BBC Biochemical lacks procedures and controls to prevent microbiological contamination of product, according to an FDA Form 483 recently handed to the contract manufacturer. Read More

FDA May Require Supplier Quality Agreements in Upcoming Guidance

The FDA is considering requiring quality agreements between medical product manufacturers and their suppliers as part of its push for tighter control of the supply chain, an FDA consumer safety officer says. Read More

AngioDynamics Warned on Reporting Failures

AngioDynamics failed to report a field correction and the possibility that one of its devices may have figured in a death or serious injury, the FDA said in a May 27 warning letter posted online Tuesday. Read More

Dendreon to Lay Off 500 Workers

Drug maker Dendreon said it would lay off 500 employees — about one-fourth of its work force — to cut costs in response to lower-than-expected sales of its new prostate-cancer treatment Provenge. Read More

Praxair India Expands Base in Western India

Praxair India plans to construct a new state-of-the-art air separation plant in the rapidly growing Pune-Mumbai industrial corridor of western India. Read More

Nectar Lifesciences Manufacturing Unit Gets U.S. FDA Nod

Nectar Lifesciences received U.S. Food and Drug Administration approval for its Active Pharmaceutical Ingredients manufacturing plant Unit-II in Dera Bassi, Punjab. Read More

Berlin Pharmaceutical, Acino Pharma Sign Partnership in Thailand

Berlin Pharmaceutical and Acino Pharma AG signed a long term partnership agreement under which Berlin will market a wide range of the Swiss company’s current and future products in Thailand. Read More

FDA Report Raises Concerns Over Medicine Shortage

A recent Food and Drug Administration report has some worrying about shortages of cancer drugs and other essential medicines. Read More

Research on Co-Crystallisation Process to Aid Pharmaceutical Industry

A new production technique has been developed by the Bradford university researchers to make co-crystals for use in the pharmaceutical industry. Read More