Ingredients

FDA issued approvals for less than half the number of new drugs in 2016 compared with 2015.

New website allows access to research quantities of commercial-grade ligands and catalysts.

Alternatives to expensive palladium catalysts are gaining acceptance for commercial API synthesis.

As of mid-December, less than half the number of new drug approvals were issued by FDA in 2016 compared with 2015.

AGC adds second biopharma contract manufacturer with acquisition of CMC Biologics.

Saneca Pharma has received a EUR1.5 million grant from the Slovak Ministry of Education, Science, Research, and Sport, which will be used to drive forward new R&D initiatives for API manufacturing.

Previous hesitation by pharma industry to use cocrystals may change with FDA’s new guidance that classifies cocrystals APIs.

Non-precious-metal catalysts are increasingly employed for commercial API synthesis.

Patheon adds API manufacturing capacity with acquisition of Roche’s Florence, SC facility.

Vendor selection and materials testing are complex enough, but in today’s volatile environment, risk mapping and monitoring are also crucial.

New catalysts show promise for pharmaceutical intermediate and API synthesis.

FDA redefines cocrystals as APIs and not drug-product intermediates.

Recipharm is investing more than EUR1.2 million to enhance its small-scale GMP API development and manufacturing capabilities in Paderno Dugnano, Italy.

he guidance addresses the good manufacturing practice for managing quality in APIs.

Researchers develop catalysts that mediate complex transformations under conditions appropriate for commercial manufacture.

BASF’s new production facility in Shanghai will produce PVP K30 powder, a polymer used as a base for pharma excipients.

Clinical biotechnology company Moderna Therapeutics will build an integrated clinical manufacturing facility for mRNA production in Norwood, Massachusetts.

The certification follows a successful inspection by the MHRA, with no critical or major observations. The site is now ready to start production.

Saneca Pharma is making significant investment in its API capabilities to support client demand for smaller batch sizes and streamlined scale-up.

Researchers at GlaxoSmithKline report a greener and lower-cost route to chiral fluorolactams that is suitable for scale up.

Sound process understanding and having effective controls in place are crucial in ensuring that consistent product quality is obtained during API manufacturing.

IPEC consultant Irwin Silverstein discusses third-party audits and regulatory compliance issues facing suppliers and their customers.

API and drug product manufacturer changes name to align with parent company.

Dalton Pharma Services completed an expansion in sterile filling and API manufacturing at its cGMP facility in Toronto, Canada.

CDMO Alcami adds HPAPI capacity and cryogenic capabilities to its Wisconsin facility.

Agilent Technologies announces plans to build a new oligo manufacturing facility in Colorado that will double current capacity.

Recent research of efficient chiral synthesis technologies reveals potential uses in API manufacturing.

Enzymatic catalysis offers pharma manufacturers a way to implement the Principles of Green Chemistry.

Multiple methods are required for detecting and removing protein impurities.

Recent chiral advances demonstrate promise for API synthesis.