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Monthly Archives: July 2016

6 Pharma API Regulatory Challenges to Watch

Posted on July 17, 2016 by

A couple of years ago, I published a post on 5 API Regulatory Challenges to Avoid, and it was interesting to look over the list and contemplate what updates I’d…

Posted in API synthesis, APIs, Big Data, FDA, genotoxic impurities, green chemistry, method development, Quality, regulatory, Route Design, Route Scouting, synthesis, Synthesis Route | Comments Off on 6 Pharma API Regulatory Challenges to Watch

What are the Key Differences with Orphan Drug Manufacturing?

Posted on July 3, 2016 by

I was asked recently what a contract manufacturer such as Neuland Labs saw as the key differences with orphan drug projects. Neuland approaches orphan drug projects slightly differently from our…

Posted in deuterium exchange, drugs, FDA, Orphan drug | Comments Off on What are the Key Differences with Orphan Drug Manufacturing?