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November 15, 2014
The authors describe a rapid, single-point calibration approach for ICP–MS analysis of raw materials used in drug product manufacturing.
October 02, 2014
Safer fluorinating reagents and access to GMP fluorination capabilities remain challenges in API synthesis.
September 02, 2014
With a quality-by-design approach, robust processes consistently can help deliver quality product.
September 01, 2014
API development and manufacturing companies expanded their capabilities, built partnerships, and achieved milestones in regulatory inspections.
August 01, 2014
Hovione announced that its API plant in Cork, Ireland has successfully passed a pre-approval inspection by FDA.
July 16, 2014
Trifarma cited for significant deviations in data collection and security, and employee training.
July 02, 2014
The pharma industry is moving toward commercial-scale continuous processes for small-molecule API manufacturing.
May 29, 2014
The Bulk Pharmaceuticals Task Force asks FDA to respond to concerns about reduction in API facility compliance inspections.
April 15, 2014
The author examines the effect of compaction force, gap width, and sieve setup on granule size.
March 02, 2014
The commercial availability of an increasing diversity of enzymes has led to the growing use of biocatalysts for API synthesis.