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Author Archives: Saharsh Davuluri

Neuland & Generic Drug Substances (GDS)

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…

Posted in API synthesis, APIs, Chemistry, Contract Manufacturing, drugs, generic, method development | Leave a comment

Pharmaceutical Manufacturing: Comparing Particle Reduction Techniques

While there are a number of particle size reduction technologies in use in the pharmaceutical industry today, from our vantage point as an API manufacturer we typically see requests for…

Posted in APIs, Chemistry, micronization, particle size, Process Engineering | Comments Off on Pharmaceutical Manufacturing: Comparing Particle Reduction Techniques

Welcome, Unit 3!

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…

Posted in CDMO, Contract Manufacturing, CRO/CMO, Neuland Labs | Comments Off on Welcome, Unit 3!

QbD and Evaluating ‘What-If’ Drug Manufacturing Scenarios

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…

Posted in API synthesis, APIs, Chemistry, CMC, Contract Manufacturing, CQA, critical reaction parameters, Design of Experiment, FDA, Impurity profile, Neuland Labs, process chemistry, QbD, Quality | Comments Off on QbD and Evaluating ‘What-If’ Drug Manufacturing Scenarios

Contract Pharma Project Management & Data Infrastructure

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…

Posted in Contract Manufacturing, CRO/CMO, data, guarD, Neuland Labs, regulatory | Comments Off on Contract Pharma Project Management & Data Infrastructure

Inside QBD: Chemists & Engineers Collaborate on Quality

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…

Posted in Chemistry, drug discovery, drugs, process chemistry, Process Engineering, QbD, Quality, R&D, Route Design, Route Scouting, scale-up, Synthesis Route | Comments Off on Inside QBD: Chemists & Engineers Collaborate on Quality

NCEs Versus Generics – Adjusting Project Tactics & Objectives to Maximize Success

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…

Posted in Contract Manufacturing, drugs, generic, NCE, process chemistry, small molecule, synthesis, Synthesis Route | Comments Off on NCEs Versus Generics – Adjusting Project Tactics & Objectives to Maximize Success

Neuland & Regulatory Excellence

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…

Posted in APIs, audit, award, Capabilities, CDMO, Contract Manufacturing, FDA, Neuland Labs, QA/QC, Quality, Quality Agreement, regulatory, Uncategorized | Comments Off on Neuland & Regulatory Excellence

Pharma APIs – What’s On Tap for 2018

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…

Posted in APIs, CDMO, Contract Manufacturing, ContractPharma.com, CRO/CMO, Neuland Labs | Comments Off on Pharma APIs – What’s On Tap for 2018

Synthetic Route Scouting: Factors to Improve API Manufacturing

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…

Posted in API synthesis, APIs, atom economy, Benign-by-Design, Chemistry, Contract Manufacturing, CRO/CMO, green chemistry, method development, Neuland Labs, outsourcing, process chemistry, Process Engineering, Route Design, Route Scouting, scale-up, Synthesis Route | Comments Off on Synthetic Route Scouting: Factors to Improve API Manufacturing