The QMN Weekly Bulletin

U.S. drugmakers looking to cut costs by moving manufacturing plants offshore may want to reconsider in light of increased quality risks, authors of a new study say.

Beckman Coulter diagnostic analyzers, reagents, calibrators and controls violate cGMP requirements, the FDA says.

FDA officials are offering mixed views on overseas inspection strategies, particularly for biologics and biosimilars, with some calling for enhanced inspections of all foreign facilities and others saying risk-based reviews work well abroad.

Pfizer has decided to open a new pharmaceutical manufacturing plant in Saudi Arabia.

Apicore announced that the U.S. Food and Drug Administration completed its first inspection of Apicore’s wholly owned subsidiary Apicore Pharmaceuticals located in Vadodara, Gujarat, India.

Abbott Laboratories will eliminate 160 jobs from its diagnostic division as part of a multiyear effort to cut costs and boost revenue for the business.

The drug company Roche has revived part of its Nutley campus with a new manufacturing operation designed to produce supplies of compounds being studied as prospective medicines.

Chemical firm Oxea has increased its manufacturing capabilities for syngas at its Bay City facility in Texas by 10 percent to further optimize its value-adding chains and boost product availability.

Quality Chemical Industries is to start manufacturing Tenofovir, a modern Antiretroviral drug in which a patient will be able to swallow one tablet a day.