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Author Archives: Saharsh Davuluri

A Review of Exciting New Peptide Drug Research

According to the FDA’s 2019 Impact Story: Developing the Tools to Evaluate Complex Drug Products – Peptides: “As a class of drugs, peptides are increasingly important in medicine. FDA is…

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2020: Looking Forward & Listening to Customers to Address Pharma Needs

2020 is here and we’re starting the New Year off right. We’re listening closer to – and learning more from – you, our customers. Last November’s CPhI Frankfurt provided valuable…

Posted in APIs, Contract Manufacturing, CPhI, CRO/CMO, generic, Neuland Labs, peptide, peptides | Tagged , , , , | Comments Off on 2020: Looking Forward & Listening to Customers to Address Pharma Needs

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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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…

Posted in API synthesis, APIs, Capabilities, Chemistry, Contract Manufacturing, CRO/CMO, drugs, Effluent, EHS, generic, Neuland Labs, outsourcing, process chemistry, Process Engineering, Quality, scale-up | Tagged , , , , , , , | Comments Off on On SABAM, Cyanide and Safety

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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