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Category Archives: APIs

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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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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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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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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Deuterated Drug Molecules: Perfecting the Gamechanger

Scientific breakthroughs in the pharmaceutical industry can happen overnight, but it still takes time to perfect a discovery’s applications. Deuterium-labeled active pharmaceutical ingredients (APIs) are one specific advancement that has…

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Where Does Pharmaceutical Process Control Start?

The idea of gaining – and maintaining – adequate process control during drug synthesis isn’t new. It underscores the entire point of approaches such as Quality by Design (QbD), and…

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What Does it Take to Become a Specialist in Late-Phase CMS?

When a drug transitions from early-stage development to late-stage development, the drugmaker has some big decisions to make. Chief among them: Who are they going to work with to move…

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