PTSM: Pharmaceutical Technology Sourcing and Management-05-06-2015

FDA steps up inspections of foreign API manufacturers, thanks to new legislation and changes in policy.

Big service providers get bigger faster thanks to Big Pharma.

Capsugel extends inhaled biotherapeutics delivery capability to Phase 2 clinical trials.

FDA cites Yunnan Hande Bio-Tech for cGMP violations related to data collection and security.

Mylan announces a recall of eight lots of injectable products due to visible foreign particulate matter.

FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.

CDMO Vetter produces identifiable labeling for a top-ten pharmaceutical company.

IDT Biologika receives 2015 Facility of the Year Award or facility integration from ISPE.

Stability testing and UPLC capabilities highlight expansion at Mumbai, India facility of SGS Life Science Services.

As a special session at Interphex 2015 this week made clear, few pharma companies are ready for serialization and aggregation deadlines. The disconnect between pharmaceutical manufacturers and their contract partners poses a special risk.

The past six months has seen some major changes to the sterile manufacturing landscape in Europe. There have been a number of exits and acquisitions that have no doubt grabbed headlines, but has anything really changed?

Rentschler Biotechnologie expands European manufacturing capabilities with GE Healthcare Life Sciences bioprocess technologies.

Recipharm makes a strategic investment in Synthonics and partners in development of novel compounds.