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How Apotex salvaged a failing pharmaceutical product using JMP
Discover how Apotex leveraged JMP to identify root causes, stabilize manufacturing, and turn a near product loss into a major business success.
This case study highlights how Apotex shifted from reactive problem-solving to a fully data-driven approach using JMP. Facing repeated failures in an ADHD medication due to unexplained variability in dissolution, the team moved beyond traditional analysis and leveraged large-scale historical data, DOE, and advanced statistical modeling.
By analyzing over 10,000 data points across years of production, they identified multiple critical factors affecting product performance, insights that were previously missed. JMP enabled the team to systematically control both physical and chemical parameters, stabilize manufacturing, and recover a product at risk of being discontinued.
Key takeaways:
- Product failures were driven by multiple interacting factors, not a single root cause.
- Analyzing full lifecycle data revealed insights that traditional approaches missed.
- Design of Experiments (DOE) validated findings and stabilized the process.
- Shifted teams from reactive troubleshooting to structured, data-driven decision making.
- JMP embedded a data-first culture where every decision requires evidence, including at the executive level.
Return on Investment (ROI):
- Saved close to $100 million by recovering a high-risk product.
- Avoided repeated batch losses of about 60,000 dollars per batch.
- Protected a product with over 40 percent market share in Canada.
- Reduced batch time by 20 to 25 percent.
- Eliminated recurring failures through parameter control.
- Enabled faster, more confident decisions and scalable improvements across products.
