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Category Archives: APIs

R&D Expert Talks Pharma API Scale Optimization

To be successful, pharmaceutical innovators and biotech organizations need to optimize production and achieve higher yields of their active pharmaceutical ingredients to make products more cost-effective. To realize these results,…

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The Crucial Role of Crystallization in Drug Substances Development

The development of drug substances heavily depends on a thorough and precise understanding of its different processes. One of these critical steps is crystallization, which has a significant impact on…

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What Pharmacological Advantages Can Deuterated APIs Deliver?

There have been significant changes in the pharmaceutical industry over the past few years, and some of them have led to significant breakthroughs. One example is the growth of deuterated…

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Advancing a Cholesterol Lowering Drug at the Height of the Pandemic

How Neuland Expanded Esperion’s Bempedoic Acid Amid Pandemic Lockdowns and Supply Chain Interruptions Just as COVID was making itself known in February 2020, the FDA was approving Esperion Therapeutics’ new…

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Putting Customers First: Customer Centricity in Pharma API Manufacturing

Customer centricity is central to every organization and an important strategic priority for B2B companies. While there are many definitions of customer centricity, the ultimate objective of a customer-centric organization…

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End-to-End Focus on Quality in API Manufacturing

The past few years have seen major changes to the ways in which drug companies and their regulators go about ensuring the safety and efficacy of drugs. The response to…

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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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