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Author Archives: Saharsh Davuluri

Speed-to-Market: Streamlining Pharma API Production

In both the generic and innovator pharmaceutical API production sectors, time-to-market is a critical factor. How critical? A one-day delay in reaching the market could mean the loss of $1…

Posted in API synthesis, APIs, Capabilities, Chemistry, Contract Manufacturing, CRO/CMO, drugs, method development, Neuland Labs, outsourcing, Paragraph IV, process chemistry, Process Engineering, speed-to-market, time-to-market | Leave a comment

November: Catching Up on Pharma Articles

This month, I managed to catch up on some of the industry articles I’ve been waiting to read which were relevant to APIs and pharma manufacturing generally. Here are a…

Posted in APIs, Contract Manufacturing, drugs, Industry news, Pharm Tech, Pharmaceutical Technology, science education | Leave a comment

3 Success Factors for Pharma Regulatory Inspections

Current Good Manufacturing Practices (cGMPs) are an essential aspect of compliance, and attention on them by regulators is growing. In today’s global pharma industry, it’s common to have multiple investigators…

Posted in APIs, audit, Capabilities, Chemistry, Contract Manufacturing, CRO/CMO, FDA, Neuland Labs, QA/QC, Quality, regulatory | Leave a comment

Continuous Improvement in Drug Manufacturing – Still a Ways to Go

The healthcare industry is driven by scientific innovation, often in response to various public health crises. But while science & discovery often leap forward, the physical act of manufacturing a…

Posted in continuous manufacturing, Pharm Tech, Pharmaceutical Technology, process chemistry | Leave a comment

How to Select a Peptide Synthesis Technique

Peptides are a complex drug class, and have historically proven challenging from a manufacturing standpoint. They are, however, experiencing a renaissance due to improvements in peptide synthesis, the development of…

Posted in API synthesis, Chemistry, CMC, Contract Manufacturing, method development, peptide, Peptide aggregation, peptides, process chemistry | Leave a comment

Leveraging QbD for API Scale Up

Earlier this month we wrote a piece on the Five Challenges Scaling Up an Active Pharmaceutical Ingredient (API). In the post’s conclusion, we discussed the role of QbD in aiding…

Posted in API synthesis, APIs, Design of Experiment, method development, Neuland Labs, QbD, Quality, regulatory, Uncategorized | Leave a comment

5 Common Challenges Scaling Up an API

While linear drug scale-up sounds great on paper, the reality is usually much different. In fact, scaling up an API can be challenging even under the best circumstances. In fact,…

Posted in APIs, CMC, Contract Manufacturing, critical reaction parameters, CRO/CMO, method development, Neuland Labs, particle size, Route Design, Route Scouting, scale-up, synthesis | Leave a comment

Neuland, Corporate Responsibility & the Movement to Eradicate Hunger

As a pharmaceutical company, Neuland has always been committed to impacting life positively across the globe. Whether it is manufacturing products to improve health, or improving the life of its…

Posted in Food waste, Neuland Labs | Leave a comment

Medicine & Science: Keeping Up with the Pace of Change

The changes we’ve witnessed in the fields of science and medicine over the last decade or two have been truly astonishing. When we stood at the beginning of the ‘omics…

Posted in analytical science, API synthesis, Big Data, Capabilities, Chemistry, Neuland Labs, peptide, peptides | Leave a comment

Inside Look: The Role of the IPR Department

Intellectual Property Rights and its Importance in Research, Business & Industry We wrote a post on the patent cliff issue back in 2015. The patent cliff has served to further…

Posted in agreement, Contract Manufacturing, IP, method development, Neuland Labs, Patent, technology transfer | Leave a comment