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Author Archives: Saharsh Davuluri

2020 & Beyond – Focus on Pharma Supply Chain (In)Security

Over the last four decades, supply chains have gone from being measured in meters to miles – and ultimately to continents & hemispheres. Without a doubt, drug industry globalization has…

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Nitrosamine Impurities and How Companies are Addressing the Crisis

We’ve recently written extensively about nitrosamine impurities, including this in-depth analysis of what transpired with Valsartan, and some follow-up material, here and here. Nitrosamine impurities have been receiving a great…

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ICH Q12 is here. What Does it Mean for Pharma?

The International Council for Harmonisation (ICH) is an organization which brings together the pharmaceutical industry and regulatory authorities to improve the synchronization of industry regulations. The organization’s ultimate goal is…

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Valsartan Contamination: A Follow-Up

Following up on our earlier post on the 2018 valsartan contamination, much has happened over the last six months. In our original post, we discussed the appearance of impurities in…

Posted in APIs, CMC, drugs, FDA, genotoxic impurities, Impurity profile, process chemistry, QA/QC, regulatory | Tagged , , , , , , | Comments Off on Valsartan Contamination: A Follow-Up

A Review of Exciting New Peptide Drug Research

According to the FDA’s 2019 Impact Story: Developing the Tools to Evaluate Complex Drug Products – Peptides: “As a class of drugs, peptides are increasingly important in medicine. FDA is…

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2020: Looking Forward & Listening to Customers to Address Pharma Needs

2020 is here and we’re starting the New Year off right. We’re listening closer to – and learning more from – you, our customers. Last November’s CPhI Frankfurt provided valuable…

Posted in APIs, Contract Manufacturing, CPhI, CRO/CMO, generic, Neuland Labs, peptide, peptides | Tagged , , , , | Comments Off on 2020: Looking Forward & Listening to Customers to Address Pharma Needs

A Few Words on Pharma Innovation…

At just about the same time we were going to write on the state of peptides (key takeaways: yes – still growing, lots of promise, more drugs in the pipeline),…

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Fostering a Quality Culture to Support Drug Manufacturing

As an API manufacturer, when it comes to product safety in the pharmaceutical space the stakes couldn’t be higher. We’ve written a few posts recently on modifications to regulatory inspection…

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What the Revised FDA CDER SSM Really Means

Confused by the new FDA CDER Site Selection Model? Here’s what you need to know. CDER – the U.S. FDA’s Center for Drug Evaluation and Research which regulates over-the-counter and…

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Drug Manufacturing: Implications of the U.S. – E.U. Mutual Recognition Agreement

In July, the United States and European Union finalized a Mutual Recognition Agreement (MRA) for drug manufacturing inspections. Both parties have now fully implemented the MRA for specific therapeutics in…

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