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I’ve been trying to get caught up on some reading this month, and thought I’d put together a roundup of interesting articles I’ve run across recently. Grading GDUFA, at Contract…
With potential projected losses of $16-32 billion for drugs going off-patent in 2015, intellectual property (IP) is increasingly crucial to keeping a competitive edge in the pharmaceutical and biotechnology markets….
There’s an article on Piramal’s Pharma Solutions division at PharmTech about how they are encouraging pharma companies to implement green chemistry earlier in the drug development cycle. Yes, we agree…
A genotoxic impurity (GTI) is a chemical substance that can directly or indirectly damage DNA or chromosomes and induce genetic mutations. Fifteen years ago, there were no specific guidelines for…
‘One hundred percent purity’ is the holy grail of pharma – and, more generally, the scientific community. Firms in our industry all around the globe spend the overwhelming majority of…
7 ways to boost profits and reduce pharma synthesis waste At Neuland, we’re advocates of green chemistry. Not only is it better for the environment, but it’s also just logistically…
There have been a number of articles recently pointing to growth in the API industry, and it’s something I’ve discussed as well – most recently in a post on the…
Impurities and the ICH Limits for Impurities Impurities are unwanted chemicals produced during normal manufacturing of Active Pharmaceutical Ingredients, or APIs. As you well know, impurities have no therapeutic value…
I’ve mentioned the importance of route scouting in the past. Now I’d like to share some of the properties of API synthesis that can affect the yield, purity, and delivery date…
In many of the blog posts we’ve written over the last few years, we’ve referenced the growing complexity of active pharmaceutical ingredients (APIs). It isn’t just mindless chatter intended to…
