Navigation For Mobile

Author Archives: Saharsh Davuluri

Europe Looks to Tighten Supply Chains

The last nine months have seen a complete re-evaluation of the risks inherent in global pharma supply chains. COVID-19 forced a doubletake in C-suites, but concern was already well on…

Posted in Quality, supply chain | Tagged , , , , , , | Leave a comment

Pharma Trends for 2021

After 2020, trying to predict anything at all seems a bit reckless. Most of us are still trying to wrap our heads around last year — and hoping this year…

Posted in APIs, blockbuster, CDMO, Chemistry, Contract Manufacturing, COVID19, CRO/CMO, outsourcing, supply chain | Tagged , , , , | Comments Off on Pharma Trends for 2021

Nitrosamines – A Timeline

Here’s an infographic detailing some of the history of nitroso compound contaminants. Nitrosamine, a probable human carcinogen, continues to make the news as the FDA, EMA and other regulatory agencies…

Posted in genotoxic impurities, Quality | Tagged , , , | Comments Off on Nitrosamines – A Timeline

Update on Regulatory Guidance for Facility Inspections

During the initial outbreak of the COVID-19 pandemic, travel and social distancing restrictions had a significant impact on regulatory inspections. In March of 2020, hands-off policies quickly became the new…

Posted in APIs, audit, Chemistry, CMC, COVID19, CRO/CMO, FDA, Industry news, Neuland Labs, QA/QC, Quality, regulatory | Tagged , , , , | Comments Off on Update on Regulatory Guidance for Facility Inspections

The Impact of Impurities on the Pharmaceutical Industry

A significant paradigm shift is underway in the regulatory environment for impurities in pharmaceutical products. Recent incidents involving genotoxic impurities (GTIs) are driving tighter restrictions and guidelines, as well as…

Posted in API synthesis, APIs, Chemistry, drugs, genotoxic impurities, Impurity profile, QA/QC, Quality, Route Design, Route Scouting, synthesis, Synthesis Route, Valsartan | Comments Off on The Impact of Impurities on the Pharmaceutical Industry

Maintaining Quality and Supply During COVID-19

The need for API manufacturers to establish strong quality systems and plan for business continuity has never been greater than it is today. And you can probably guess the reason…

Posted in APIs, Chemistry, Contract Manufacturing, COVID19 | Tagged , , , | Comments Off on Maintaining Quality and Supply During COVID-19

The Need for Speed: Drug Development, Trials & Regulatory Pathways Accelerate in the Wake of COVID-19

For drug makers, speed has always mattered. Every day a drug is delayed on the path to market costs pharma companies millions of dollars. Delays can also lead to the…

Posted in analytical science, Chemistry, COVID19, drug discovery, drugs | Tagged , , , , , , | Comments Off on The Need for Speed: Drug Development, Trials & Regulatory Pathways Accelerate in the Wake of COVID-19

API Industry Faces Challenges and Opportunities

The global market for active pharmaceutical ingredients (APIs) is expected to grow at a 3–6% Compound Annual Growth Rate (CAGR) over the next five years, exceeding U.S. $1.5 trillion by…

Posted in API synthesis, APIs, Chemistry, Contract Manufacturing, COVID19, drugs, India, supply chain | Comments Off on API Industry Faces Challenges and Opportunities

Looking for an API Supplier? 5 Things to Consider (Updated)

Seven years ago – in March of 2013 – we published a blog post on 5 Things to Consider When Looking for an API Supplier. Because seven human years equals…

Posted in API synthesis, APIs, Chemistry, CMC, Contract Manufacturing, drugs, FDA, Neuland Labs, process chemistry, Process Engineering, Project Management, Quality, R&D, regulatory, supply chain, synthesis | Tagged , , | Comments Off on Looking for an API Supplier? 5 Things to Consider (Updated)

Pharma Drug Innovation in 2020: From Novel Drugs to Drugs for Novel Coronavirus

Have other areas in drug discovery suffered because of COVID-19? It’s probably not too early to say that COVID-19 has changed pharmaceutical drug discovery considerably. And why wouldn’t it have,…

Posted in Chemistry, drug discovery, drugs, FDA, Neuland Labs, R&D, regulatory | Tagged , , | Comments Off on Pharma Drug Innovation in 2020: From Novel Drugs to Drugs for Novel Coronavirus