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Category Archives: outsourcing

Economic Nationalism or Global Cooperation? How About a “Thank You,” Instead?

I saw this lede for an article (Bio/Pharma, People, Perseverance, and Hope) about 2020 by Rita Peters at PharmTech and smiled. It captured the state of life sciences this past…

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Pharma Trends for 2021

After 2020, trying to predict anything at all seems a bit reckless. Most of us are still trying to wrap our heads around last year — and hoping this year…

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Coronavirus & Drug Supply Chains: The Pharma Industry Searches for Answers

Coronavirus has impacted drug supply chains. At first blush, people will likely read that sentence to mean drugs aren’t arriving at their intended destination. That precursor chemicals, intermediaries, APIs, or…

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2020 & Beyond – Focus on Pharma Supply Chain (In)Security

Over the last four decades, supply chains have gone from being measured in meters to miles – and ultimately to continents & hemispheres. Without a doubt, drug industry globalization has…

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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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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

Pharma API Supply Chains: Mitigating Risk

The risks to pharmaceutical supply chains grow in parallel with the industry itself. As drug markets have become increasingly complex and global in nature, so – too – have drug…

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Synthetic Route Scouting: Factors to Improve API Manufacturing

Synthetic route selection is a crucial element in API manufacturing. While the requirements of the synthetic process of a drug will naturally evolve during its life cycle, scouting alternate routes…

Posted in API synthesis, APIs, atom economy, Benign-by-Design, Chemistry, Contract Manufacturing, CRO/CMO, green chemistry, method development, Neuland Labs, outsourcing, process chemistry, Process Engineering, Route Design, Route Scouting, scale-up, Synthesis Route | Comments Off on Synthetic Route Scouting: Factors to Improve API Manufacturing

Speed-to-Market: Streamlining Pharma API Production

In both the generic and innovator pharmaceutical API production sectors, time-to-market is a critical factor. How critical? A one-day delay in reaching the market could mean the loss of $1…

Posted in API synthesis, APIs, Capabilities, Chemistry, Contract Manufacturing, CRO/CMO, drugs, method development, Neuland Labs, outsourcing, Paragraph IV, process chemistry, Process Engineering, speed-to-market, time-to-market | Comments Off on Speed-to-Market: Streamlining Pharma API Production

Defining the Contract Pharma Provider Relationship

I read an article at Pharmaceutical Manufacturing earlier this year (Inking the Deal: Mastering the art of lasting outsourcing relationships in the pharmaceutical industry) on the nature of contract pharma…

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