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Author Archives: Saharsh Davuluri

3 Key Elements of a Successful Hydrogenation Scale-Up

Pharmaceutical process chemistry has come a long way since wholesale merchants began the commercial marketing of drugs in the 19th century. In fact, process chemistry has driven many of the…

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Pharma Industry Zeroes in on Drug Manufacturing Sustainability

Sustainability has become a key trend in drug manufacturing. As we’ve previously discussed (here and here), this is being driven by environmental/good corporate stewardship efforts as well as various cost…

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A Novel Method of Manufacturing Alcaftadine

Conjunctivitis (known as ‘pink eye’) is the infection or inflammation of the conjunctiva—the mucous membrane that covers the eye’s outer surface. In the United States, this uncomfortable ophthalmic condition affects…

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Why is Pharmaceutical Green Chemistry Use on the Rise?

Green chemistry principles first emerged in the 1990s, and the pharmaceutical industry – especially larger, global organizations – began steadily incorporating its principles in subsequent years. Here are some recent…

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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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