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Category Archives: API synthesis

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…

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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)

China Launches New Marketing Authorization Holder (MAH) System

In December 2019, China issued a revision to their Drug Administration Law. It was the most wide-ranging modification of their laws since 2001. It marked a fundamental shift away from…

Posted in API synthesis, APIs, drug discovery, drugs, regulatory | Comments Off on China Launches New Marketing Authorization Holder (MAH) System

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.

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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…

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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

What the Revised FDA CDER SSM Really Means

Confused by the new FDA CDER Site Selection Model? Here’s what you need to know. CDER – the U.S. FDA’s Center for Drug Evaluation and Research which regulates over-the-counter and…

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Complex Synthesis in Action: Achieving a Commercial-Scale 16 AA Peptide

Peptide process development projects have increased in the last few years. Judging by our blog readership and social interactions, interest in peptide drugs is continuing to grow by leaps and…

Posted in API synthesis, APIs, Chemistry, Contract Manufacturing, peptide, peptides, scale-up, Uncategorized | Tagged , , | Comments Off on Complex Synthesis in Action: Achieving a Commercial-Scale 16 AA Peptide

A Guide to Sourcing Pharmaceutical Peptide APIs

Rise of the Peptide Era                                                                                                                                                       Peptide synthesis has a long pharmaceutical history, stretching back to the early 1900s – and then followed by a lengthy period of dormancy….

Posted in API synthesis, APIs, Capabilities, Chemistry, chromatography, CMC, Contract Manufacturing, CRO/CMO, Fmoc, generic, HPLC, Jitsubo, Molecular Hiving, Neuland Labs, peptide, Peptide aggregation, peptides, process chemistry, Process Engineering, synthesis, Synthesis Route, TIDES | Tagged , | Comments Off on A Guide to Sourcing Pharmaceutical Peptide APIs

Pharma Tech Transfer Gets Collaborative

Drug manufacturing technology transfer is one of the most complicated and demanding processes in the drug company-contract development organization relationship. There is one overriding deliverable that must go right –…

Posted in API synthesis, Chemistry, CMC, Contract Manufacturing, method development, process chemistry, Process Engineering, R&D, scale-up, technology transfer | Tagged , , | Comments Off on Pharma Tech Transfer Gets Collaborative