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Manufacturing

Dedicated to cGMP Performance at Every Stage

Manufacturing semi-solids, such as ointments, creams, lotions, and gels, as well as non-sterile liquids, like nasal sprays, suspensions, and solutions, requires more than just capacity. It demands technical precision, formulation insight, predictable scale-up, and a strong foundation of GMP manufacturing excellence.

For more than 35 years, CPL has provided integrated GMP manufacturing for some of the industry’s most complex topical and liquid drug products, supporting early-phase clinical supply, late-stage process validation, and long-term commercial production for global pharmaceutical innovators and generic companies. Our manufacturing model is built on one principle: certainty through continuity.

CPL's Solution

Scale-Up Surprises, Fragmented Partners, and Quality Risks

Industry Challenge

Time-consuming handoffs between development labs and external manufacturers.

A seamless, end-to-end development-to-manufacturing ecosystem.

CPL integrates formulation, analytical development, process development, and GMP manufacturing under one roof, minimizing handoffs and accelerating progress.

Industry Challenge

Loss of process knowledge during tech transfer.

Proven, phase-appropriate tech transfer framework.

CPL maintains knowledge continuity through structured documentation, equipment matching, scale-up modeling, and cross-functional involvement from the start.

Industry Challenge

Inconsistent or incomplete process validation packages.

Integrated analytical, development, and validation approach.

CPL’s teams collaborate to ensure every validation package is complete, compliant, and built on consistent, phase-appropriate data.

Industry Challenge

Delays in clinical manufacturing and batch release.

In-house analytical testing, QC, and clinical manufacturing.

CPL accelerates batch release with internal testing, stability, documentation, and GMP clinical manufacturing capabilities.

Industry Challenge

Scale-up failures due to challenging process parameters.

Scalability is designed from day one.

CPL aligns process development with equipment capability, rheology, heat/shear requirements, and manufacturability assessments to ensure predictable scale-up.

Industry Challenge

Generalist CDMOs lack true specialization in semi-solids and liquid formulations.

A CDMO purpose-built for semi-solids and non-sterile liquids.

With 35+ years focused exclusively on creams, ointments, gels, suspensions, solutions, and nasal sprays, CPL provides unmatched expertise in complex topical and liquid manufacturing.

CPL’s Solution

Dedicated GMP Manufacturing for Semi-Solids & Non-Sterile Liquids

CPL offers an end-to-end cGMP manufacturing ecosystem engineered to meet the specific demands of topicals and liquid drug products.

A Proven, Phase-Appropriate Transfer Framework

Gap analysis to identify risks

Process mapping and critical process parameter assessment

Equipment alignment at bench, pilot, and commercial scales

Scale-up strategy for high-viscosity, heat-sensitive, and other challenging formulations

Analytical method readiness

Risk-based sampling and control strategies

GMP Production for Phase I–III Clinical Supplies

Semi-solids like ointments, creams, gels, and lotions

Non-sterile liquids like suspensions and solutions

Hormone-based and alcohol-containing formulations

Stability testing services

Batch release testing through in-house analytical labs

Container-closure system verification

Packaging, labeling, and track and trace serialization for clinical distribution

Commercial Manufacturing

Reliable, Scalable cGMP Manufacturing for Commercial-Scale Products

Full-scale GMP manufacturing

Validated processes for semi-solids and non-sterile liquids

State-of-the-art equipment ensures efficiency and capacity

Lot-to-lot consistency and yield optimization

Commercial packaging, labeling, and DSCSA serialization and aggregation

Ongoing analytical support, stability programs, and method lifecycle management

Why Clients Choose CPL for Manufacturing

Dedicated Expertise in Topicals & Non-Sterile Liquids

Decades of experience in semi-solid and non-sterile liquid formulations equip our team to deliver for even the most complex formulations

End-to-End Integration with Development & Testing

Manufacturing is directly supported by internal analytical method development, product testing, and our Skin Lab for <i>in vitro</i> testing

Reduced Risk During Scale-Up & Validation

CPL’s continuity from formulation through commercial reduces rework, batch failures, and regulatory gaps

GMP Compliance

Strong audit history, validated processes, and market-ready quality systems support a reliable long-term supply

Commitment.
Partnership. Legacy.

Leverage CPL’s 35 years of expertise in non-sterile liquids and semi-solids to ensure your program's success. We’ll support your product from molecule to market, or step in at any stage of its product lifecycle.

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