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Author Archives: Saharsh Davuluri

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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Drug Manufacturing: Implications of the U.S. – E.U. Mutual Recognition Agreement

In July, the United States and European Union finalized a Mutual Recognition Agreement (MRA) for drug manufacturing inspections. Both parties have now fully implemented the MRA for specific therapeutics in…

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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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On SABAM, Cyanide and Safety

Levetiracetam, an epilepsy medication used for partial onset, myoclonic or tonic-clonic seizures, was first approved for medical use in the United States in 1999. As a drug, it boasts excellent…

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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

Successful Pharmaceutical Project Management

Think about your last project. How many individuals and departments participated? How many locations around the world did it involve? How smoothly did the project progress? Could you have improved…

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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…

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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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How the Valsartan Contamination Happened: Its Context & Implications

Last year’s valsartan contamination and recall brought some surprising chemical synthesis issues to light in the pharma industry. While the reactions used in generic valsartan production are known to be…

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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…

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