APIs and Excipients

Hazardous reagents can simplify processes and provide higher yields and purities.

Nanoscale catalysts and engineered nanoparticles may have a big impact on small-molecule pharmaceuticals.

A strong API market is expected in 2016 despite fewer new drug approvals.

Efficient syntheses are possible using multi-component and cross-dehydrogenative, heteroaromatic C–H silylation reactions

Efficient syntheses are possible using multi-component and cross-dehydrogenative, heteroaromatic C-H silylation reactions.

The company has exclusive distribution agreement for a range of APIs such as cafféine, mometasone furoate, diclofenac sodium, sodium valproate, and esomeprazole magnesium dehydrate. Its portfolio of excipients includes release agents, direct compression agents, and matrix agents.

Safer solid reagents and new coupling chemistry are important developments.

CPhI Worldwide and co-located events ICSE, InnoPak, P-MEC, and LABWorld 2015 bring technologies, processes, and services from all phases of the drug development and manufacturing spectrum to one location.

Winners from the seven categories will be announced live at the event in Madrid.

More complex drug candidates require more specialized and selective chemistry.

Potential for improved product quality and cost/time savings is reviving interest in perfusion technology.

FDA, Congress, and early adopters look to speed up the use of continuous API manufacturing.

Safer reagents and reaction conditions are making many hazardous transformations possible.

An integrated pilot plant tests heteronucleation and continuous crystallization.

New legislation and changes in policy at FDA are leading to better control of the API supply chain.

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

Resolution technologies remain crucial for commercial-scale chiral API production.

Changing dynamics of the pharmaceutical industry are driving demand.

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

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.

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

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

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

Transition metal-containing catalysts are widely used in organic synthesis, but many are based on expensive, rare metals. Researchers are seeking more sustainable alternatives.

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

Increasing potency and growing interest in antibody-drug conjugates are creating challenges for manufacturers of HPAPIs.

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

Emerging markets are an engine for growth in the custom-manufacturing and pharma markets.

A review of this year's crop of the new molecular entities and new biologics license applications approved by FDA thus far in 2013.