APIs and Excipients

Fluorination Remains Key Challenge in API Synthesis

October 02, 2014

Safer fluorinating reagents and access to GMP fluorination capabilities remain challenges in API synthesis.

DuPont Adds New Alginate-Based Excipient to Pharma Portfolio

September 23, 2014

DuPont Nutrition & Health has added a new pharmaceutical excipient to the portfolio of ingredients for CPhI Worldwide 2014, in Paris this October.

Asymmetric Synthesis Continues to Advance

September 02, 2014

A survey of the recent literature reveals numerous advances in asymmetric chemocatalysis.

QbD in API Manufacturing

September 02, 2014

With a quality-by-design approach, robust processes consistently can help deliver quality product.

Exploring a New Approval Process for Continued Excipient Innovation

September 01, 2014

New excipients and improvements to existing excipients are needed to facilitate access to new drugs for patients.

Meeting the Challenges of Excipient Variability

September 01, 2014

The quality and composition of excipients can vary due to environmental factors, processing methods, raw material quality, manufacturing location changes, and even operator actions.

A Practical Approach of Implementing GMP for Excipients

September 01, 2014

Using a model quality risk-management process according to ICH Q9, the authors discuss ways to apply this guideline.

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.