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Category Archives: Chemistry

API Industry Faces Challenges and Opportunities

The global market for active pharmaceutical ingredients (APIs) is expected to grow at a 3–6% Compound Annual Growth Rate (CAGR) over the next five years, exceeding U.S. $1.5 trillion by…

Posted in API synthesis, APIs, Chemistry, Contract Manufacturing, COVID19, drugs, India, supply chain | Comments Off on API Industry Faces Challenges and Opportunities

Looking for an API Supplier? 5 Things to Consider (Updated)

Seven years ago – in March of 2013 – we published a blog post on 5 Things to Consider When Looking for an API Supplier. Because seven human years equals…

Posted in API synthesis, APIs, Chemistry, CMC, Contract Manufacturing, drugs, FDA, Neuland Labs, process chemistry, Process Engineering, Project Management, Quality, R&D, regulatory, supply chain, synthesis | Tagged , , | Comments Off on Looking for an API Supplier? 5 Things to Consider (Updated)

Pharma Drug Innovation in 2020: From Novel Drugs to Drugs for Novel Coronavirus

Have other areas in drug discovery suffered because of COVID-19? It’s probably not too early to say that COVID-19 has changed pharmaceutical drug discovery considerably. And why wouldn’t it have,…

Posted in Chemistry, drug discovery, drugs, FDA, Neuland Labs, R&D, regulatory | Tagged , , | Comments Off on Pharma Drug Innovation in 2020: From Novel Drugs to Drugs for Novel Coronavirus

Video: Pharmaceutical Analytical Capabilities & Drug Quality

Drug quality and strong analytical capabilities go hand-in-hand. It is virtually impossible to achieve the former without the latter at all stages of a drug’s development and production.

Posted in API synthesis, APIs, Chemistry, chromatography, drugs, QA/QC, Quality | Tagged , , , | Comments Off on Video: Pharmaceutical Analytical Capabilities & Drug Quality

Process Validation: Maintaining Quality Consistency

The basic principle of pharmaceutical quality assurance is that a drug should be safe and effective for its intended use – and process validation plays a pivotal role in ensuring…

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Drug Scale Up: Planning for Clinical Success

Consistent – Yet Still Low – Clinical Success Rates The number of drug candidates which are approved, get to market and subsequently become profitable for industry is pretty low. And…

Posted in API synthesis, APIs, Chemistry, CMC, scale-up | Tagged , , | Comments Off on Drug Scale Up: Planning for Clinical Success

Nitrosamine Impurities and How Companies are Addressing the Crisis

We’ve recently written extensively about nitrosamine impurities, including this in-depth analysis of what transpired with Valsartan, and some follow-up material, here and here. Nitrosamine impurities have been receiving a great…

Posted in analytical science, API synthesis, APIs, Chemistry, CMC, genotoxic impurities, Quality, Valsartan | Tagged , , , , , | Comments Off on Nitrosamine Impurities and How Companies are Addressing the Crisis

A Few Words on Pharma Innovation…

At just about the same time we were going to write on the state of peptides (key takeaways: yes – still growing, lots of promise, more drugs in the pipeline),…

Posted in APIs, Chemistry, drugs, Neuland Labs, R&D | Tagged , | Comments Off on A Few Words on Pharma Innovation…

Unique API Particle Size Projects On the Rise

Why is there a growing preoccupation with particle size? It’s because particle size can alter the efficacy (e.g., bioavailability) and safety profile (e.g., toxicity) of a compound. Complex particle sizing…

Posted in APIs, Chemistry, CMC, drugs, Impurity profile, micronization, Neuland Labs, particle size, process chemistry, Process Engineering, QbD | Comments Off on Unique API Particle Size Projects On the Rise

Solving the Insoluble

Soluble drug APIs are now the exception, not the rule. An article at PharmTech by Felicity Thomas (Looking Beyond the Solubility Horizon) caught my eye recently as it discussed a…

Posted in APIs, Capabilities, Chemistry, Contract Manufacturing, CRO/CMO, Pharm Tech, Pharmaceutical Technology, R&D, Route Design, Route Scouting, synthesis | Tagged , , , , | Comments Off on Solving the Insoluble