Generics: U.S. Drug Industry Dominance The last time you filled a prescription, was it a generic or a brand name drug? An astonishing 89% of all drug prescriptions in the…
In recent posts on the topic of Quality by Design and drug manufacturing, we referenced (here, here and here) the importance of being able to reduce unanticipated challenges by developing…
In a PharmTech webcast, the Neuland team linked up with Dr. San Kiang – Research Professor from the Department of Chemical Engineering at Rutgers University. The objective was a discussion…
With more than 650 regulatory filings to date, Neuland is committed to total compliance and regulatory excellence. In fact, we consider it our core competency: the application of strong process…
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…
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…
Neuland has recently welcomed the addition of a new, dedicated Process Engineering Lab to its R&D Center. The lab opened in March, and supports operations and safety studies via a…
I read an article at PharmTech at the tail end of 2016 that I thought was quite interesting, and it reflects Neuland’s position on regulatory agencies & issues. The article…
We are firm believers that quality is more important than…well…everything in the pharma business. It’s very simple: in this highly-regulated industry, without quality – a company has no value. We…
One portion of an article at PharmTech (Five Themes That Will Drive the CMO Industry) discussing opportunities for smaller CMOs recently caught my eye. It mentioned that those aforementioned opportunities…