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June 27, 2008

Vol. 2 No. 26

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Instituting Manufacturing Changes Without 510(k) Draws Warning Letter

Devicemaker Steris made several significant changes to an FDA-cleared product — changes that warranted a new premarket submission, according to a recent warning letter. Read More

Production a Key Focus of Medtronic’s Cost Strategy

As part of Medtronic’s efforts to rein in costs, a large portion of its anticipated savings will come from reducing the cost of manufacturing, a company executive said. Read More

Boehringer Ingelheim Initiates Recalls

Boehringer Ingelheim recalled 2.2 million Zantac tablets last month because the drug exceeded limits for S-oxide, an impurity. Read More

Pfizer Pays Penalty for Pollution Violation

Pfizer, the world's largest drugmaker, has agreed to pay a $975,000 civil penalty to resolve alleged violations of the Clean Air Act at its former manufacturing plant in Groton, Conn., federal officials announced. Read More

Microbix to Join in Chinese Flu Vaccine Plant

China is getting a replica of Dr. Norman Bethune's childhood home as part of a venture in which Microbix Biosystems Inc. is joining a Chinese provincial government in an influenza vaccine production plant. Read More

NanoGuardian Client Receives FDA Approval for its Nanoencryption Technology

NanoGuardian, a division of NanoInk that focuses exclusively on delivering brand protection solutions to fight illegal diversion and counterfeiting, announced that the Food and Drug Administration (FDA) has issued approval to a NanoGuardian client to use NanoGuardian's … NanoEncryption technology as an on-dosage, brand protection technology. Read More

Johnson Medtech Expands Device Manufacturing Capabilities

Johnson Medtech, the medical products group of Johnson Electric, one of the world’s largest providers of motion actuators, announced the opening of four new cleanrooms in Shajing, China. Read More

Bafna Pharma Bags Nod for Export Facility

Bafna Pharmaceuticals (Bafna), a multi-product pharmaceutical formulations company in diverse therapeutic segments, has received Medicines and Health Care Products Regulatory Agency (MHRA) approval for its facility meant for exports to the UK markets and European Union. Read More

Biotech Firm Gets Ready to Grow in Antibodies

Alder is looking for experts in antibody manufacturing and clinical development, including a director of clinical operations, a medical director and clinical-study managers. Read More