The QMN Weekly Bulletin

The drug industry is seeing a spike in pharmaceutical recalls as the agency ramps up inspections and warning letters, a new report states.

Amid continuing concern that breaks in the global supply chain will beget another heparin crisis, FDA inspectors are upping scrutiny of drug and device manufacturers’ supplier controls to ensure they are sufficiently robust and clearly articulated in scientific terms, agency officials say.

The FDA and European Medicines Agency (EMA) plan to step up cooperation on manufacturing inspections next month, moving from information sharing and joint inspections to outright reliance on one another’s results.

Indian pharmaceutical giant Ranbaxy Laboratories said that it has signed a settlement with the U.S. Food and Drug Administration, committing to bolster its product manufacturing practices.

Canada is helping Novocol Pharmaceuticals of Canada expand and modernize the company’s Cambridge facility.

BioMarin Pharmaceutical received recommendation of approval for the company’s manufacturing facility expansion in Novato, Calif., by the Committee for Medicinal Products for Human Use of the European Medicines Agency.

Andhra Pradesh government has issued a notice to the city-based drug maker Aurobindo Pharma in connection with a fire accident last month that claimed lives of two workers at its manufacturing plant located in Srikakulam district, a senior official said.

A biotechnology company secured more than $588,000 investment to develop cancer treatments. ADC Biotechnology, based in St Asaph, is developing “superior production technology” to support its new antibody drug production process.

GMP standard will be introduced at all Armenian pharmaceutical companies, to be followed by an application to a relevant panel of the EU to recognize the process.