APIs and Excipients

Changing dynamics of the pharmaceutical industry are driving demand.

Analytical and procedural deficiencies result in FDA warning letter for Novacyl Wuxi Pharmaceutical.

Protein Sciences will evaluate sourcing Flublok from its Japanese licensee, UMN Pharma, which already runs a large-scale facility for the vaccine.

FDA approves treatments for new diseases and drugs that operate by new mechanisms.

The authors describe a rapid, single-point calibration approach for ICP–MS analysis of raw materials used in drug product manufacturing.

Recent technology introductions demonstrate that accuracy, efficiency, and usability are top of mind for pharmaceutical industry professionals for analytical instruments.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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.

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

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

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

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

Experts share insights on how product appearance such as size, shape, color, and imprint can make a difference in reducing medication errors.

Lifecycle management opportunities are impacting the development of controlled-release technologies for solid-dosage drugs.