APIs and Excipients

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.

BPTF Warns FDA on Reduced API Manufacturer Inspections

May 29, 2014

PTSM: Pharmaceutical Technology Sourcing and Management

The Bulk Pharmaceuticals Task Force asks FDA to respond to concerns about reduction in API facility compliance inspections.

Scientific Advances in Cocrystals are Offset by Regulatory Uncertainty

May 02, 2014

Drug developers are taking a wait-and-see approach to the use of cocrystals.

Gallus BioPharmaceuticals Enters Agreement with Omni Bio Pharmaceutical

May 01, 2014

PTSM: Pharmaceutical Technology Sourcing and Management

Gallus BioPharmaceuticals enters a cell line optimization and manufacturing agreement with Omni Bio Pharmaceutical.