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Author Archives: Saharsh Davuluri

Selecting Regulatory Starting Materials: A Q&A With Neuland’s Senior VP of Supply Chain Management

As a follow-up to our recent two-part series on Regulatory Starting Materials Sourcing & Supplier Management, we sat down with Senior Vice President of Supply Chain Management at Neuland Labs…

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Regulatory Starting Materials: How to Source, Analyze and Validate Suppliers (Part II)

In Part I of this two-part series, we explored sourcing and supplier management of Regulatory Starting Materials (RSMs), and how effective designation and justification of RSMs begins with supplier market…

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Regulatory Starting Materials: How to Source, Analyze and Validate Suppliers (Part I)

Supply chain management is an essential chapter in the pharmaceutical manufacturing handbook. Managing regulatory starting materials (RSMs) seeks to maximize commercialization and sustainability while meeting and/or exceeding regulatory requirements. Drugmakers…

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100 Years of Learning from Pharmaceutical Impurities

In 1905, George Santayana published his famous aphorism: “Those who cannot remember the past are condemned to repeat it.” More than 100 years later, this is could be an unofficial guiding principle…

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Real-Time Remote GMP Inspections by Key Regulatory Agencies

We’ve arrived at a time in which real-time remote GMP inspections of drug manufacturing facilities are an actual thing – and not just an “it would be nice to have…

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The Generics Wave – Ups, Downs and Constancy

A recent article at DCAT Value Chain Insights (Generics: What is the Next Industry Move?) shone a light on recent movements in the generics space by the MNCs, including  Novartis…

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Green Generic Drug Substances: Increased Upfront Costs Offset by Long-Term Profitability

Green initiatives may be slowly gaining some traction across the pharmaceutical industry, but there is still a long way to go. These are some astonishing insights from sciencehistory.org. “On a waste-to-product…

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Exploring Neuland’s Therapeutic Segments: Focus on CNS

Drug development is exciting. There’s no getting around it: being a part of an industry which aims to improve human health is a great motivator for waking up and heading…

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Green Chemistry by Design (GCbD): The Earlier, The Better for Pharmaceutical APIs

There’s a growing consensus in the pharmaceutical industry that drug makers should embrace green chemistry. The last decade of pharma manufacturing has seen green chemistry practices shift from aspirational stewardship…

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The Growing Impact of Rare Disease Drugs

AstraZeneca’s $39-billion acquisition of Alexion Pharmaceuticals  joined by Merck’s acquisition of Acceleron for $11.5 billion and other deals, have made the Rare Disease space a destination for Big Pharma this…

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