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Author Archives: Saharsh Davuluri

Generic Drugs: Despite Dominance, Consumer Perception Issues Linger

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…

Posted in APIs, drugs, generic, Neuland Labs, Quality, regulatory, supply chain | Leave a comment

Neuland Patent Spotlight: Entacapone & Parkinson’s Disease

Treating the Symptoms of Parkinson’s Disease According to the Parkinson’s Foundation, Parkinson’s Disease (PD) affects about one million people in the U.S., and 10 million worldwide. While there is no…

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API Synthesis Properties Affecting Yield, Delivery Date & Purity

Properties which can affect an API’s yield, delivery date and purity include: Type of Synthesis Propinquity Complexity of Structure Cost Efficient Synthesis Carryover of impurities into drug substance Minimum isolation…

Posted in API synthesis, APIs, Chemistry, CMC, method development, Neuland Labs, process chemistry, Process Engineering, Route Design, Route Scouting, synthesis, Synthesis Route | Comments Off on API Synthesis Properties Affecting Yield, Delivery Date & Purity

Overcoming Challenges in Complex Peptide Purification

Growth in Peptide Demand In its most recent market report, Grandview Research estimated the peptide therapeutics market will reach nearly $50 billion. Of particular interest is what is driving the…

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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 | Comments Off on Neuland & Generic Drug Substances (GDS)

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…

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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…

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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