11.08.25 -- Outsourced Pharma Best Of October

Chief Editor Louis Garguilo writes: "For the first time in more than a decade writing this column, I’ll focus on a specific 483 – actually two – received by a CDMO site. It pains me to do so, for a number of reasons. But the overall industry reaction to this specific FDA issuance compels me to take this on." Read about the 483 heard round the world, and what it means for CDMOs, sponsors, and the FDA.

Italians, the quiet ones? Perhaps. The relative attention Italy collects in our industry is not commensurate with the substantial development and manufacturing outsourcing that takes place in this European nation. Coming out of COVID a few years ago, Italy is now the largest CDMO market in Europe, ahead of Germany’s ~$3 billion, and France’s $2.49 billion. 

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

In your CDMO search, prioritize finding a partner who recognizes impurity control as a critical component of patient-focused drug development and offers the necessary capabilities to ensure it.

If you’re launching an international clinical trial, consider the noteworthy benefits of partnering with an in-country depot, including increased efficiency, reduced costs, and reliable access to raw materials.

Accelerate the development of high-quality biopharmaceuticals by implementing phase-appropriate, risk-based manufacturing and testing strategies that ensure timely progression.