Yearly Archives: 2013

Therapeutic Peptides – Has This Emerging Market Grown Up?

Posted on April 22, 2013 by Saharsh Davuluri

Yes – The Peptide Drug Market Has Come of Age. Peptide drugs are not a new phenomenon by any stretch of the imagination. The first approved peptide-based drug – insulin…

Posted in APIs, Congtract Manufacturing, drug delivery, peptides | Comments Off

Planning for the Future: Evaluating a CMO’s Regulatory Capabilities

Posted on April 1, 2013 by Saharsh Davuluri

For those of you keeping your eye on regulatory matters, 2013 has the potential to be a big year as the FDA gears up to release new guidance on a…

Posted in CEP, Congtract Manufacturing, CRO/CMO, DMF, FDA, QA/QC, regulatory | Comments Off

Manufacturing Collaboration with Mitsubishi Healthcare Unit API Corporation

Posted on March 13, 2013 by Saharsh Davuluri

Some exciting news for Neuland Labs this week: we’ve just entered into a manufacturing collaboration with Tokyo-based API Corporation (APIC) – a healthcare unit of Mitsubishi Chemical Holdings Group. As…

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Looking for an API Supplier? 5 Things to Consider

Posted on March 6, 2013 by Saharsh Davuluri

Outsourcing production of APIs provides pharmaceutical and biotech companies the benefit of API scale-up and production expertise while allowing them to focus on their core business – the research and…

Posted in APIs, Contract Manufacturing, CRO/CMO, QA/QC, regulatory | Comments Off

API Manufacture: Identifying & Controlling Genotoxic Impurities

Posted on January 28, 2013 by Saharsh Davuluri

Since API manufacturing plays a critical role during clinical development and after approval of a drug, familiarity with genotoxic impurities is an important issue for pharmaceutical firms considering outsourced API…

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