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Category Archives: drugs

China Launches New Marketing Authorization Holder (MAH) System

In December 2019, China issued a revision to their Drug Administration Law. It was the most wide-ranging modification of their laws since 2001. It marked a fundamental shift away from…

Posted in API synthesis, APIs, drug discovery, drugs, regulatory | Comments Off on China Launches New Marketing Authorization Holder (MAH) System

Video: Pharmaceutical Analytical Capabilities & Drug Quality

Drug quality and strong analytical capabilities go hand-in-hand. It is virtually impossible to achieve the former without the latter at all stages of a drug’s development and production.

Posted in API synthesis, APIs, Chemistry, chromatography, drugs, QA/QC, Quality | Tagged , , , | Comments Off on Video: Pharmaceutical Analytical Capabilities & Drug Quality

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

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 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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Unique API Particle Size Projects On the Rise

Why is there a growing preoccupation with particle size? It’s because particle size can alter the efficacy (e.g., bioavailability) and safety profile (e.g., toxicity) of a compound. Complex particle sizing…

Posted in APIs, Chemistry, CMC, drugs, Impurity profile, micronization, Neuland Labs, particle size, process chemistry, Process Engineering, QbD | Comments Off on Unique API Particle Size Projects On the Rise

Alzheimer’s and Brain Awareness Month

June is Alzheimer’s and Brain Awareness Month. Alzheimer’s Disease (AD) is a heartbreaking and tragic condition affecting millions of families worldwide. This month, we highlight how health and pharma intersect….

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The Unblockbuster – Speeding Cures with Specialty Drugs

For years, industry soothsayers have suggested the imminent demise of blockbuster drugs was upon us (here’s one from 2009 – Goodbye blockbuster medicines; hello new pharmaceutical business models). But two…

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