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Author Archives: Saharsh Davuluri

Process Validation: Maintaining Quality Consistency

The basic principle of pharmaceutical quality assurance is that a drug should be safe and effective for its intended use – and process validation plays a pivotal role in ensuring…

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Coronavirus & Drug Supply Chains: The Pharma Industry Searches for Answers

Coronavirus has impacted drug supply chains. At first blush, people will likely read that sentence to mean drugs aren’t arriving at their intended destination. That precursor chemicals, intermediaries, APIs, or…

Posted in APIs, Contract Manufacturing, drugs, Effluent, EHS, green chemistry, outsourcing, supply chain | Tagged , , | Comments Off on Coronavirus & Drug Supply Chains: The Pharma Industry Searches for Answers

On-Site Pharma Audits During the Coronavirus (COVID-19) Crisis

The outbreak of COVID-19 has significantly impacted physical visits to drug manufacturing facilities. This raises a number of challenges, since many regulations — especially those relating to inspections — weren’t written with…

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COPD Product Development Opportunity: Indacaterol Maleate

According to the American Lung Association, chronic obstructive pulmonary disease (COPD – which includes chronic bronchitis and emphysema) is the third-leading cause of disease-related death in the U.S. It affects…

Posted in Capabilities, COPD, CRO/CMO, DMF, drugs, FDA, generic, Indacaterol, marketing, Neuland Labs, Patent | Tagged , , , , , , | Comments Off on COPD Product Development Opportunity: Indacaterol Maleate

Drug Scale Up: Planning for Clinical Success

Consistent – Yet Still Low – Clinical Success Rates The number of drug candidates which are approved, get to market and subsequently become profitable for industry is pretty low. And…

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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…

Posted in analytical science, API synthesis, APIs, Chemistry, CMC, genotoxic impurities, Quality, Valsartan | Tagged , , , , , | Comments Off on Nitrosamine Impurities and How Companies are Addressing the Crisis

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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