APIs and Excipients

API Developers Pass Inspections and Upgrade Capabilities

September 01, 2014

API development and manufacturing companies expanded their capabilities, built partnerships, and achieved milestones in regulatory inspections.

Risk Reduction Top Driver for Biopharmaceutical Raw Material Development

August 02, 2014

Customers are looking to reduce risk, increase performance, and optimize productivity.

Hovione's API Facility in Cork, Ireland Passes FDA Inspection

August 01, 2014

PTSM: Pharmaceutical Technology Sourcing and Management

Hovione announced that its API plant in Cork, Ireland has successfully passed a pre-approval inspection by FDA.

Pharmaceutical Technology Europe

How Excipient Supplier Certification Helps Pharmaceutical Supply Chain in Europe

August 01, 2014

The EXCiPACT Certification Scheme ensures patient safety through supplier quality while minimising the audit burden and overall costs for assessing the excipient supply chain.

Study Shows Capsugel's Capsules as Suitable Excipients in QbD-based Product Development and Manufacturing

July 29, 2014

PTSM: Pharmaceutical Technology Sourcing and Management

Study provides first substantive reference data on key quality attributes of empty capsules

FDA Issues Warning Letter to Italian API Manufacturer

July 16, 2014

PTSM: Pharmaceutical Technology Sourcing and Management

Trifarma cited for significant deviations in data collection and security, and employee training.

The Mainstreaming of Continuous Flow API Synthesis

July 02, 2014

The pharma industry is moving toward commercial-scale continuous processes for small-molecule API manufacturing.

Biotage Launches Accelerated Chromatographic Isolation

June 30, 2014

Biotage has launched a purification technology, Accelerated Chromatographic Isolation (ACI), which converts simple flash purification into a faster and more economical way to isolate pure compounds.

Seeking Alternative Catalyst Solutions

June 02, 2014

Transition metal-containing catalysts are widely used in organic synthesis, but many are based on expensive, rare metals. Researchers are seeking more sustainable alternatives.

DCAT Sharp Sourcing Addresses Procurement Topics

May 30, 2014

PTSM: Pharmaceutical Technology Sourcing and Management

DCAT's Sharp Sourcing 2014 educational program offers pharmaceutical and biopharmaceutical companies a forum to gain best practice insights in sourcing and procurement.