Concerns over data manipulation lands Chinese API maker with US FDA Warning
The US FDA has hit cancer-drug API maker Yunnan Hande Bio-Tech with a warning letter citing concerns over potential manipulation of quality test data at a plant in China.
The US FDA has hit cancer-drug API maker Yunnan Hande Bio-Tech with a warning letter citing concerns over potential manipulation of quality test data at a plant in China.
Recipharm has begun negotiations to manufacture a prostate cancer drug-device candidate for Swedish pharma firm LIDDS.
Genentech scientists have created a faster, cheaper way to identify cell lines, a boon for CMOs and preclinical researchers.
Pfizer has selected PPD as its third preferred contract research organisation (CRO), but the addition will not affect ongoing relationships with Parexel and Icon, the firm says.
Dispatches from Interphex
The world’s top pharma and biologics manufacturing and processing companies have come together in New York this week to showcase the latest in equipment and services.
Understanding international regulatory demands, manufacturing standards and overcoming cultural barriers are key for Asian drugmakers looking to enter Western markets, says market access CRO ELC Group.
Sigma-Aldrich has opened a cell culture Technical Center in Singapore and plans to expand further in the city-state with a cGMP distribution site.