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PTSM: Pharmaceutical Technology Sourcing and Management-05-06-2015
PTSM: Pharmaceutical Technology Sourcing and Management
Better Control of the API Supply Chain?
May 04, 2015
API Synthesis and Manufacturing
11
5
FDA steps up inspections of foreign API manufacturers, thanks to new legislation and changes in policy.
Big Pharma Feeds Big CMO Growth
May 04, 2015
Outsourcing
11
5
Big service providers get bigger faster thanks to Big Pharma.
Capsugel Produces DPI Phase 2 Trial Supplies
May 04, 2015
Contract Services
11
5
Capsugel extends inhaled biotherapeutics delivery capability to Phase 2 clinical trials.
Chinese API Manufacturer Warned for Data Integrity Issues
May 04, 2015
API Synthesis and Manufacturing
11
5
FDA cites Yunnan Hande Bio-Tech for cGMP violations related to data collection and security.
Mylan Recalls Injectables Due to Visible Particulate Matter
April 28, 2015
Regulation and Compliance
11
5
Mylan announces a recall of eight lots of injectable products due to visible foreign particulate matter.
FDA Releases Final Biosimilar Guidance
April 28, 2015
Regulation and Compliance
11
5
FDA releases long-awaited guidance documents regarding the assessment of biosimilarity.
Vetter Serializes First Product for South Korea
April 28, 2015
Supply Chain
11
5
CDMO Vetter produces identifiable labeling for a top-ten pharmaceutical company.
IDT Biologika Vaccine Facility Recognized
April 28, 2015
Contract Services
11
5
IDT Biologika receives 2015 Facility of the Year Award or facility integration from ISPE.
SGS Completes Expansion at Mumbai Facility
April 27, 2015
Contract Services
11
5
Stability testing and UPLC capabilities highlight expansion at Mumbai, India facility of SGS Life Science Services.
Serialization: Deja Vu All Over Again?
April 24, 2015
Supply Chain
11
5
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.
Gauging Change in Europe’s Sterile Manufacturing Market
April 22, 2015
Outsourcing
11
5
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 Single-Use Capabilities
April 17, 2015
Contract Services
11
5
Rentschler Biotechnologie expands European manufacturing capabilities with GE Healthcare Life Sciences bioprocess technologies.
Recipharm Invests in Sythonics
April 16, 2015
Contract Services
11
5
Recipharm makes a strategic investment in Synthonics and partners in development of novel compounds.