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Category Archives: APIs

How CMO Expertise Can Solve Key Challenges in Late Phase Drug API Projects

Stating the obvious here, but drug development is a protracted, expensive and risky process. From the lab bench to pharmacy shelves, bringing a new drug to market often stretches 10+…

Posted in APIs, Capabilities, Chemistry, CMC, Contract Manufacturing, CRO/CMO, drugs, method development, Neuland Labs, outsourcing, process chemistry, Process Engineering, scale-up | Tagged , , , , | Comments Off on How CMO Expertise Can Solve Key Challenges in Late Phase Drug API Projects

How to Create Sustainable Drug Lifecycles with Alternate Route Scouting

Demands on a drug’s synthetic processes naturally evolve during its lifecycle. Scouting alternative methods for synthesizing active pharmaceutical ingredients (APIs) early in process development — before they are needed by changing…

Posted in API synthesis, APIs, atom economy, Chemistry, Effluent, EHS, energy conservation, energy effciency, green chemistry, process chemistry, Route Design, Route Scouting, synthesis, Synthesis Route | Tagged , | Comments Off on How to Create Sustainable Drug Lifecycles with Alternate Route Scouting

Why You Need to Have the ‘Supply Chain’ Conversation with Your Pharma Suppliers

Supply chain security has been the subject of numerous posts on this blog in the past. It is important to note, however, that the pandemic hasn’t widely impacted global supply…

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Generic Drug Opportunities in Global Markets

Generic drugs have moved quickly over the last 30 years into a position of dominance in drug markets around the world. In 2018, generic drug savings totaled $293 billion in…

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API Production: Building a Process Safety Culture

Working in the pharmaceutical manufacturing industry may bring many rewards, but it also has an element of risk. We often work alongside hazardous chemicals, in both labs and manufacturing spaces….

Posted in API synthesis, APIs, Capabilities, Chemistry, EHS, Neuland Labs, process chemistry, Process Engineering, safety | Tagged , , , | Comments Off on API Production: Building a Process Safety Culture

Overcoming the Challenges of API Complexity

Pharmaceutical drug molecules are becoming increasingly complex, posing challenges in formulation development and manufacturing. This is particularly true of small molecule drug APIs and peptides, both of which have a…

Posted in API synthesis, APIs, atom economy, Chemistry, corporate stewardship, drugs, Effluent, EHS, energy conservation, energy effciency, green chemistry, Neuland Labs | Tagged , , , , | Comments Off on Overcoming the Challenges of API Complexity

Weighing the Potential for APIs and Finished Dosage Forms in Emerging Markets

New markets for drug manufacturers are emerging worldwide in regions that have typically purchased and imported drugs in finished dosage forms. While this shift has been underway for a few…

Posted in API synthesis, APIs, Chemistry, Contract Manufacturing, drugs, generic, Neuland Labs, supply chain | Tagged , , , , , | Comments Off on Weighing the Potential for APIs and Finished Dosage Forms in Emerging Markets

Economic Nationalism or Global Cooperation? How About a “Thank You,” Instead?

I saw this lede for an article (Bio/Pharma, People, Perseverance, and Hope) about 2020 by Rita Peters at PharmTech and smiled. It captured the state of life sciences this past…

Posted in APIs, drugs, India, Neuland Labs, outsourcing, supply chain | Tagged , , , | Comments Off on Economic Nationalism or Global Cooperation? How About a “Thank You,” Instead?

Pharma Trends for 2021

After 2020, trying to predict anything at all seems a bit reckless. Most of us are still trying to wrap our heads around last year — and hoping this year…

Posted in APIs, blockbuster, CDMO, Chemistry, Contract Manufacturing, COVID19, CRO/CMO, outsourcing, supply chain | Tagged , , , , | Comments Off on Pharma Trends for 2021

Update on Regulatory Guidance for Facility Inspections

During the initial outbreak of the COVID-19 pandemic, travel and social distancing restrictions had a significant impact on regulatory inspections. In March of 2020, hands-off policies quickly became the new…

Posted in APIs, audit, Chemistry, CMC, COVID19, CRO/CMO, FDA, Industry news, Neuland Labs, QA/QC, Quality, regulatory | Tagged , , , , | Comments Off on Update on Regulatory Guidance for Facility Inspections