Granulation Excellence for CMOs and CDMOs: Compliance and Flexibility in Modern Pharmaceutical 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.

Key Granulation Needs for CMO/CDMO Operations

Flexibility and Scalability

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.

Regulatory Compliance

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.

Facility Integration and Efficiency

Compact footprints, cleanroom compatibility, and ease of integration into existing layouts minimize downtime and maximize facility output.

What to Look for in a Granulation Solution

When evaluating equipment for granulation, we recommend prioritizing systems that offer:

• Fast changeover
• GMP-compliant design and documentation
• Modular platforms that support both development and commercial-scale production
• Proven support for process validation

Market Context: U.S. Pharmaceutical CDMO Landscape

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.

Partnering for Success: LCI Corporation (Nederman Group)

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:

• Extrusion and spheronization wet granulation systems suitable for production of pellets for oral solid dosage
• Batch and continuous processing systems designed for flexibility and rapid scale-up
• Technical and validation support to streamline your commissioning and regulatory process

LCI’s solutions are backed by decades of pharmaceutical engineering expertise, helping contract manufacturers meet both operational and compliance objectives.

Conclusion

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.