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Category Archives: Neuland Labs

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),…

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Fostering a Quality Culture to Support Drug Manufacturing

As an API manufacturer, when it comes to product safety in the pharmaceutical space the stakes couldn’t be higher. We’ve written a few posts recently on modifications to regulatory inspection…

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From the Neuland Reading Room

I thought I’d share some good reads this month. Have you checked out these articles? What did you think? 1989 to Present: PharmTech Highlights 30 Years of Bio/Pharma PharmTech tackles…

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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

How Pharma Controls Generic & NCE Manufacturing Costs by Backward Integrating APIs Ingredients

The pharma industry is facing some outsized business challenges at present – from burgeoning trade wars to downward-pricing pressures and increased regulatory scrutiny. More than one conversation our team members…

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Alzheimer’s and Brain Awareness Month

June is Alzheimer’s and Brain Awareness Month. Alzheimer’s Disease (AD) is a heartbreaking and tragic condition affecting millions of families worldwide. This month, we highlight how health and pharma intersect….

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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

Deuterated Drugs Reach Two-Year Anniversary

We’ve reached the two year anniversary of the first FDA approval of a deuterated molecule (April 2017, Teva’s Astedo – a deuterated version of tetrabenazine for the treatment of Huntington’s…

Posted in APIs, Chemistry, CMC, Contract Manufacturing, deuterated molecule, deuteration, deuterium exchange, method development, Neuland Labs, process chemistry | Tagged , , , | Comments Off on Deuterated Drugs Reach Two-Year Anniversary

TIDES TV: The Past, Present & Future of Peptides

Dr. Mike Anwer – Neuland’s President of Peptide Synthesis – recently sat down with Andy Busrt of TIDES TV to discuss the peptide drug market. Peptides – From Insulin to…

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Inside Neuland Technology: Bosentan Monohydrate

Pulmonary arterial hypertension (PAH) is a rare disease affecting 1-2 people per million in the U.S. and Europe. The orphan drug Bosentan, a dual endothelin receptor antagonist, is used in…

Posted in API synthesis, APIs, Capabilities, Chemistry, Contract Manufacturing, drugs, generic, method development, Neuland Labs, Orphan drug | Tagged , , | Comments Off on Inside Neuland Technology: Bosentan Monohydrate