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Category Archives: genotoxic impurities

APIs & Chemistry: The Importance of Understanding Critical Reaction Parameters

Active Pharmaceutical Ingredients (APIs, or – in layman’s terms – the ingredients that makes drugs work) have grown increasingly complex. Today’s equivalent of boiling tree bark into a tincture typically…

Posted in analytical science, Capabilities, Chemistry, critical reaction parameters, drugs, genotoxic impurities, method development, QA/QC, R&D, scale-up | Comments Off on APIs & Chemistry: The Importance of Understanding Critical Reaction Parameters

Analytical Capabilities and Drug Quality – Key to Successful Pharma Outsourcing

Last week, we wrote a post on new analytical methods for the detection of impurities that our R&D group had developed for the drug Febuxostat. And we’ve done the same…

Posted in analytical science, APIs, Capabilities, Chemistry, Contract Manufacturing, CRO/CMO, Febuxostat, genotoxic impurities, method development, Neuland Labs, QA/QC, regulatory | Comments Off on Analytical Capabilities and Drug Quality – Key to Successful Pharma Outsourcing

The Contract Manufacturing & Intellectual Property Challenge: Solution? Don’t Compete With the Customer.

Intellectual property rights have always been integral to negotiations for pharmaceutical contract manufacturing services, but growing complexities surrounding global IP issues, complex science, inevitable process improvements, IT infrastructure & security,…

Posted in agreement, APIs, Contract Manufacturing, CRO/CMO, genotoxic impurities, QA/QC, Uncategorized | Comments Off on The Contract Manufacturing & Intellectual Property Challenge: Solution? Don’t Compete With the Customer.

Genotoxic Impurities – Article in PharmTech

Related to our (persistent!) emphasis on regulatory excellence and complex chemistry capabilities, team members from Neuland Lab’s Analytical Research & Development Department at our R&D Centre developed and validated a…

Posted in Chemistry, genotoxic impurities, Pharmaceutical Technology, R&D, regulatory | Comments Off on Genotoxic Impurities – Article in PharmTech

Neuland Success Stories: Taking U.S. Customers from Phase II into Commercialization

With research becoming highly-specialized, many companies are turning to CROs with particular skill-sets – especially in complex chemistry. For us at Neuland, companies tend to be looking for method development…

Posted in APIs, Contract Manufacturing, CRO/CMO, DMF, FDA, genotoxic impurities | Comments Off on Neuland Success Stories: Taking U.S. Customers from Phase II into Commercialization

API Manufacture: Identifying & Controlling Genotoxic Impurities

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…

Posted in APIs, Congtract Manufacturing, genotoxic impurities | Comments Off on API Manufacture: Identifying & Controlling Genotoxic Impurities