API Synthesis and Manufacturing, Small Molecule

Regulators Tackle Nitrosamine Contamination in Prescription and OTC Ulcer and Heartburn Medications

September 16, 2019

EMA plans to issue new guidance, as US and European regulators respond to reports of nitrosamine contamination in H2 blockers, including Zantac, that contain rantidine.

Quantitation of Mutagenic Impurities in APIs Using a Platform Chip-Based CE–MS Method

August 02, 2019

The ZipChip CE-ESI interface was evaluated for suitability as a platform approach for quantitation of MIs in API.

Designing Phase-Appropriate CMC Analytical Programs

August 01, 2019

A one-size-fits-all strategy is not the best approach for the development of a chemistry, manufacturing, and controls program.

Catalent Extends Spray Drying Capabilities in Europe

July 16, 2019

An agreement with Sanofi gives Catalent access to commercial spray drying facility in Haverhill, UK.

Facilitating API Delivery with Nanoscale Solutions

July 02, 2019

Nanotechnology is enabling enhanced bioavailability, improved stability, and targeted delivery of challenging APIs.

Concept Life Sciences Opens New API Facility in UK

June 19, 2019

New CDMO facility supports early-stage API manufacturing and scale up.

Lonza Expands HPAPI Capacity

June 17, 2019

Two additional production lines expand Lonza’s HPAPI capacity at Visp, Switzerland facility.

Pfizer to Acquire Array BioPharma

June 17, 2019

Pfizer’s acquisition of Array BioPharma expands the company’s pipeline of investigational cancer therapies.

Enabling Technologies Advance Poorly Soluble Highly Potent APIs

June 02, 2019

Excipients and new processing techniques can make a real difference in the development of highly potent therapies.

Considering Alternative API Filtration Technologies

May 03, 2019

Automated candle and pressure-plate filtration equipment for removing catalyst residues from API slurries are operated in a closed system.