Category Archives: QbD

Moving Towards Specialty APIs

Posted on May 15, 2016 by Saharsh Davuluri

In a recent issue of PharmTech, Agnes Shanley wrote an article on the specialty markets and services driving the growth of APIs in which we were featured. For me, the…

Posted in API synthesis, Capabilities, Chemistry, CMC, Contract Manufacturing, CRO/CMO, Neuland Labs, outsourcing, Pharm Tech, Pharmaceutical Technology, QbD, Quality | Comments Off

APIs – Continued Growth, Increasing Complexity

Posted on June 14, 2015 by Saharsh Davuluri

I was interviewed back in April for a Pharmaceutical Technology (PharmTech) article about demand drivers for small-molecule APIs. The article by Agnes Shanley – Pharma APIs: It’s Still a Small…

Posted in API synthesis, APIs, Pharm Tech, Pharmaceutical Technology, QbD, small molecule | Comments Off

You Can’t Keep a Good Drug Down

Posted on December 2, 2014 by Saharsh Davuluri

Reducing Mutagens, Carcinogens & Other Genotoxins to Improve Safety Profiles There are a number of process modifications API manufacturers can make to improve safety profiles, reduce production costs, improve capacity…

Posted in analytical science, APIs, Capabilities, Chemistry, CMC, Contract Manufacturing, critical reaction parameters, CRO/CMO, drugs, EHS, genotoxic impurities, green chemistry, method development, Neuland Labs, QA/QC, QbD, R&D, regulatory, Route Design, scale-up, Synthesis Route, zero liquid discharge | Comments Off

Five Trends in API Development & Production

Posted on November 4, 2014 by Saharsh Davuluri

There have been some tremendous gains made in the pharma industry’s understanding of Active Pharmaceutical Ingredient (API) design, and it’s reflected in the APIs currently in development around the globe….