Manufacturing
Cambrex is accelerating API capacity expansion across the US and Europe, advancing a $120m Iowa project and a $30m Milan upgrade as it builds scale in complex chemistries, peptides and high-potency manufacturing amid rising reshoring demand.
“In a very siloed organization made up of a jigsaw of different companies, no one was thinking enterprise first,” says Perrigo CEO Patrick Lockwood-Taylor. “The fundamentals of running operations, brand-building, innovation, they are now as they were.”
Alvotech is shifting toward dual-source manufacturing and operational execution as it addresses FDA setbacks, expands its biosimilar pipeline and drives growth through global launches, with US approvals representing key upside to its 2026 outlook.
Antonio Martinez Descalzo has more than 20 years' experience in life sciences, health and nutraceutical industries, including with food and beverage giant ADM. Israeli firm has completed pilot production and is moving into full manufacturing.
FY 2026 OMUFA facility fees are $19,188 for OTC monograph drug manufacturers and $12,792 for contract manufacturing organizations also making the products. FY 2025 fees were $37,556 and $25,037.
Deal pairs SteinCares’ regional commercialization platform with Shilpa Biologicals’ development and manufacturing capabilities for an undisclosed biosimilar.
Kabi targets mid- to high-single-digit growth and a 16.5%-17% EBIT margin in 2026, raising its long-term ambition as it pivots toward biopharma and innovation – while warning margin gains hinge on volume ramp and operating leverage.
Industry continues to oppose domestic manufacturing incentives that the FDA wants to include in the PDUFA reauthorization.
CRDMOs must embrace AI to keep pace with big pharma partners - but what is expected of them, which data can they use, where are Indian firms on the adoption curve and does the ‘China Plus One’ business proposition still hold? Leaders discussed these topics at BioAsia.
Including OTC studies in special protocol assessments will be addressed in FDA guidance required in 15 months on improving predictability of process and standards for approval of OTC drug applications, while stepwise labeling information will be post online to improve visibility and searchability fo
India pharma leaders emphasize the need for AI integration beyond pilots, calling for an enterprise mindset to drive AI adoption and a focus on re-skilling for ‘everyone’. Discussions touched on AI’s role in driving manufacturing efficiencies and also India’s innovation trajectory.
Sandoz enjoyed good sales and profit growth in 2025, with a significant increase in free cash flow allowing the firm to continue investing in its major European biosimilars manufacturing network.