Ingredients

FDA Issues Warning Letter to Cadila Pharmaceuticals for CGMP Deviations

November 13, 2014

The agency cites deviations from CGMPs for the manufacture of APIs at the company?s Gujarat, India plant.

Aqueous Acrylic Enteric Coating System

November 06, 2014

Acryl-EZE II is an optimized aqueous acrylic enteric system from Colorcon.

Advances in Large-Scale Heterocyclic Synthesis

November 02, 2014

New practical approaches to the synthesis of complex heterocycles are reviewed.

Fluorination Remains Key Challenge in API Synthesis

October 02, 2014

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

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.

Taking Action on Elemental Impurities

September 01, 2014

Changing regulations are impacting the identification and monitoring of variable materials in excipients.

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.

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.