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Author Archives: Saharsh Davuluri

API Particle Size Part 2: New & Emerging Technologies Impacting Particle Size

Welcome to Part 2 of our series on managing API particle size. (You can find Part 1 here.) Today we’re talking about some of the new and emerging technologies that…

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API Particle Size Part I: Overcoming the Challenges to Ensure Quality Pharmaceutical Products

API particle size is a key consideration in manufacturing quality pharmaceutical products, however, particle size is also notoriously difficult to control during manufacturing. Despite the difficulty, it’s essential to get…

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Scaling-up Active Pharmaceutical Ingredient (API) Chemistry for Phase 3 Clinical Trials and Bulk Manufacturing for a Potentially Novel Treatment for Schizophrenia

Selecting the right pharmaceutical contract manufacturing partner for Phase 3 clinical and commercial supply is challenging. There are several critical qualifiers you need to consider: Do they have the expertise…

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Challenges of Working with Specialty Drug APIs

Specialty drug APIs are both a blessing and a challenge for pharmaceutical companies. They are essential for treating patients and saving lives. The demand for them is high, which promises…

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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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Integrating Sustainability into Pharma Manufacturing

Respected Irish business Niall FitzGerald once said, “Sustainability is here to stay or we may not be.” A supporter of sustainable business initiatives in Europe, he has also pointed out…

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8 Ways Effective Supply Chain Management Can Minimize Pharmaceutical Supply Chain Challenges

Supply chain disruptions leading to drug shortages aren’t a new challenge. In fact, the FDA maintains a database of current shortages. But the problem appears to have become more pervasive…

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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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