Small-Molecule APIs

Ionic liquid technologies offer a new way to improve bioavailability.

Protecting workers, patients, and the environment requires advanced technologies.

Assessing risk factors is key to implementing the new ICH Q3D guidelines for elemental impurities.

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

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

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

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

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

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

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.

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

The author examines the effect of compaction force, gap width, and sieve setup on granule size.

The commercial availability of an increasing diversity of enzymes has led to the growing use of biocatalysts for API synthesis.

Recent regulatory initiatives designed to secure the global pharmaceutical supply chain will directly impact the global supply chain and API manufacturers.

PIC/S reviews deficiencies found during inspections of API manufacturing facilities, harmonizes GMP standards, and provides training for inspectors worldwide.

Fine-chemical companies, contract manufacturers, and researchers advance chemocatalysis and biocatalysis.

With the enforcement of the European Directive 2011/62/EU relating to medicinal products for human use regarding falsified medicinal products, new requirements are introduced for active substances. The new regulation requires among other things, documentation of the supply chain traceability.

Cedarburg Hauser Pharmaceuticals has upgraded its API plant in Wisconsin.

New partnership aims to eliminate months from the typical transition time required to move chemistry from the laboratory into commercial applications.

Industry experts share their views on the outsourcing model and the current and future direction of contract chemical API manufacturing.

Commercial-scale amide formation and an improved process route for a tetracycline derivative are some recent developments in API synthesis.

A simple, rapid analytical method for the determination of palladium in pharmaceutical production samples will speed up development and optimization of reactions involving palladium catalysts.

Industry groups offered perspectives on the strengths and weaknesses of the European Falsified Medicines Directive.

External manufacturing plays a crucial role in pharmaceutical companies’ supply strategy. The author examines market trends for the captive and merchant global market for active pharmaceutical ingredients and intermediates.

Novel, atom-efficient routes to amides from esters and carboxylic acids for more sustainable manufacturing.

New routes enable the efficient synthesis of enantiopure sulfinamides and structurally and sterically diverse P-chiral phosphine oxides.

Cocrystals can enable the formulation of solid dosage drugs, but the FDA's final guidelines have left concerns about how their use could impact development timelines, the drug product manufacturing process, and the intellectual property position of products containing cocrystals.

Dynamic testing and advances in shear testing provide better insight into powder physical properties and external variables that affect powder behavior.

Access to extremely low and consistently controlled reaction temperatures can improve product yields and selectivities while also reducing costs.