Many manufacturers can successfully support early clinical programs, but challenges often emerge when it’s time to scale for commercial demand. Differences in equipment size, process trains, and manufacturing capabilities can create risks during scale-up and technology transfer. At Forma, we’ve built our manufacturing network with scalability in mind by offering aligned process trains across development and commercial operations, along with equipment redundancy to help ensure smoother, more reliable scale-up from clinic to commercial production.
Commercial Manufacturing
Scale from Phase III
to Market
Our California facilities has supported the commercialization of 20+ programs over the past two decades, with peak production exceeding 1,000 lots and 2B+ dosage forms annually. At Forma, we combine hands-on manufacturing experience, strong quality systems, and practical scientific expertise to help clients confidently scale and launch their programs.
Scaling Challenges We Master
Successfully transitioning from late-phase clinical to full commercial production requires specialized expertise
Regulatory Compliance
Forma operates with established GMP-compliant systems and proven operational processes designed to help programs move forward with confidence. From product quality to controlled substance handling, our teams work proactively to ensure regulatory expectations are built into every stage of development and manufacturing.
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Forma is fully licensed to manufacture Schedule II–V controlled drug products, with the infrastructure and operational controls needed to safely handle complex molecules. Our experienced teams help clients navigate regulatory and manufacturing challenges to confidently bring critical therapies to market.
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Forma maintains specialized containment capabilities for safely handling high-potency APIs, supporting compounds up to OHC 3 with OELs ranging from 0.03 μg/m³ to 10 μg/m³. Our experienced teams and established containment controls help clients confidently advance potent compounds through development and manufacturing.
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Our Irvine site builds on decades of commercial manufacturing experience, with a legacy spanning Anchen, Par Pharmaceutical, and Endo. Backed by a strong operational foundation and proven regulatory track record, the site continues to support programs from development through commercialization with confidence.
Manufacturing Capacity
Clinical to Commercial Scale
World-class infrastructure designed to meet global demand
2B+ Annual Dose Capacity
Manufacturing over two billion oral doses annually across clinical and commercial programs.
5 R&D Suites
5 dedicated non-GMP suites that allow R&D experimentation quickly and efficiently
100K Square Feet
State-of-the-art GMP facilities across two sites in California
27 GMP Suites
Dedicated manufacturing environments supporting complex oral dosage forms
Supply Reliability
Dependable manufacturing operations you can count on for uninterrupted supply
Irvine, California
Facility Overview
Fairbanks Site (Irvine, CA)
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60,000 sq ft
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1,000 pallet warehouse
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16 GMP suites
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Commercial scale equipment (e.g., 1,000L fluid bed granulator, 71 station tablet press)
Jeronimo Site (Irvine, CA)
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40,000 sq ft
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5,000 sq ft of GMP lab space
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11 GMP Suites
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5 dedicated R&D suites