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From the day Neuland was established in 1984, our core business and operational expertise has been the manufacturing of Generic Drug Substances. More specifically, delivering niche, highly-specialized and complex synthetic…
Late last year, Neuland completed the acquisition of an API/Intermediate manufacturing facility in Hyderabad – now designated Unit III. The Unit III facility is spread across 12 acres and offers…
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…
For pharma manufacturers, developing rock-solid data infrastructure has become essential. It touches everything we do as a CDMO – from the web-based intranet used for Employee Self Service (ESS), Sales…
Since generic drugs are – on average – 20 to 90% cheaper than innovator drugs (or NCEs), the market for generics has grown considerably in recent years as a means…
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…
Gil Roth, president of the Pharma & Biopharma Outsourcing Association, recently published a piece at Contract Pharma on the challenges and opportunities facing CMOs/CDMOs. The hot button issues he described…
Synthetic route selection is a crucial element in API manufacturing. While the requirements of the synthetic process of a drug will naturally evolve during its life cycle, scouting alternate routes…
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…
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…
