As a Contract Manufacturing or Contract Development and Manufacturing Organization, your business is built on agility, reliability, and trust. Your clients expect the highest levels of compliance, quality, and responsiveness; especially when it comes to solid dosage manufacturing.
Granulation is a core process in this space, and it presents a unique set of challenges. Whether you are handling highly potent APIs, working across multiple product lines, or scaling from pilot to commercial production, your granulation systems must support safety, productivity, and regulatory confidence at every level.
We are going to outline the granulation requirements for CMOs and CDMOs and highlight key operational and compliance challenges. Our guide below will help in selecting systems that support long-term success.
Your production schedules are often fluid, with varying batch sizes and development phases. Granulation equipment must be scalable, modular, and capable of rapid changeovers to meet these demands without compromising process consistency.
Meeting the expectations of agencies such as the FDA, EMA, and PMDA requires built-in validation support, electronic batch records, and full GMP compliance. Equipment that facilitates audit readiness is essential.
Compact footprints, cleanroom compatibility, and ease of integration into existing layouts minimize downtime and maximize facility output.
When evaluating equipment for granulation, we recommend prioritizing systems that offer:
The U.S. pharmaceutical CDMO market is experiencing significant growth, driven by increasing demand for biologics, biosimilars, and complex drug formulations. According to market research, the U.S. pharmaceutical CDMO market size was valued at approximately USD 40.52 billion in 2024 and is projected to exceed USD 83.25 billion by 2034, expanding at a compound annual growth rate (CAGR) of 7.50%.
The active pharmaceutical ingredient (API) manufacturing segment accounted for the largest market share in 2023, while the finished dosage formulation (FDF) development and manufacturing segment is expected to grow at a significant CAGR during the forecast period.
LCI Corporation, a member of the Nederman Group, specializes in equipment for pharmaceutical powder processing, including advanced granulation technologies tailored to CMO/CDMO operations.
Key Capabilities Include:
LCI’s solutions are backed by decades of pharmaceutical engineering expertise, helping contract manufacturers meet both operational and compliance objectives.
Your success as a CMO or CDMO depends on more than capacity—it requires process reliability, regulatory confidence, and the ability to respond to client needs without delay. When it comes to granulation, these capabilities begin with the right equipment strategy.
By prioritizing systems that integrate compliance and flexibility, you position your organization to serve current clients more effectively and prepare for the next generation of pharmaceutical partnerships.
To learn more about how LCI can support your granulation strategy, contact us to begin a consultation.