Commercial Manufacturing
Where Semi-Solid and Non-Sterile Liquid Expertise Meets Reliable Scale
Commercial manufacturing of semi-solid and non-sterile liquid products is unforgiving, as small shifts in raw material supply, mixing, filling, packaging, or microbiological control can severely compromise product quality, stability, dose uniformity, and on-time delivery. As a pure-play CDMO, CPL brings more than 35 years of focused expertise in these complex dosage forms. Our resilient supply chain management, seamless tech transfer across phases and scales, and compliant GMP operations result in inspection-ready commercial-scale manufacturing that consistently delivers high-quality, reliable supply for our clients.
Scalable Commercial Manufacturing Built on Quality and OTIF Delivery
- Quality
- Compliance
- OTIF
- Agile Operations
- Global Customers
CPL brings decades of compliant commercial manufacturing experience in semi-solid and non-sterile liquid drug products for clients worldwide, with a reputation built on consistently delivering on-time and in-full (OTIF). From our 140,000-ft² FDA- and Health Canada–registered GMP manufacturing, packaging, and warehousing facility, we produce batches up to 5,000 kg and can rapidly ramp capacity when demand spikes. Additionally, we are committed to serving our clients’ needs for cost-effective production well into the future by investing in ongoing process optimization, leveraging technologies such as further line automation and vision systems.
Integrated, Data-Driven Supply Chain for Reliable, On-Time Commercial Supply
- Agile Operations
- Demand Planning
- Monthly Reviews
- KPI Monitoring
CPL’s supply chain team manages the whole order cycle, uniting customer service, procurement, inventory, and warehouse/logistics into a single effort. Managing more than 350 qualified vendors and over 1,000 different materials and components, we treat suppliers as partners, not just vendors. We conduct monthly reviews with top customers and suppliers, manage 12-month rolling demand plans, and monitor critical KPIs for OTIF, vendor performance, and material costs to advance transparency, efficiency, and proactive risk management. The result is a resilient, data-driven supply chain capable of agility, responding to shifts in demand and changing production schedules.
Proven Global Compliance and Inspection Readiness
Regular inspections by Health Canada, the FDA, and ANVISA have resulted in no actions of note. Our outstanding history of compliance and Exchange of Certificates of GMP Compliance allows CPL to serve markets around the world, including the EU, UK, Mexico, MENA, Japan, and Australia.
Specialized Capabilities & Expertise for Demanding Products
CPL reliably develops and manufactures demanding semi-solid and non-sterile liquid products, including male and female hormone therapies, corticosteroids, alcohol-containing formulations, and light-sensitive products, applying rigorous controls to protect potency, stability, and operator safety.
CPL Experience Spotlight
Agile Operations & Partnership Maintained Commercial Supply
Dedicated to Excellence
from Molecule to Commercialization
CPL supports programs from early-phase through commercial launch, combining preformulation insight, robust semi-solid and non-sterile liquid development, scalable process design, and clinical and commercial manufacturing.
Pharmaceutical Development Services
Pharmaceutical Development Services
Comprehensive expertise that turns molecules into scalable, compliant, market‑ready semi-solid and non-sterile therapies.
Analytical & Product Testing
Analytical & Product Testing
Robust analytics power confident development and manufacture of topical and non-sterile liquid products.
Clinical & Commercial Manufacturing
Clinical & Commercial Manufacturing
More than three decades of GMP manufacturing experience from clinical supply through commercialization.
Packaging, Labeling & Serialization
Packaging, Labeling & Serialization
Integrated packaging, serialization, and aggregation ensure compliant, continuous commercial supply.
Semi-Solid & Non-Sterile Liquid Expertise
Semi-Solid & Non-Sterile Liquid Expertise
Pure-play CDMO for semi-solids and non-sterile liquids, with advanced micro encapsulation capabilities.
Unique Product Handling Experience
Unique Product Handling Experience
Infrastructure and expertise to manage complex, higher-risk semi-solid and non-sterile liquid products.
FAQs
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Commercial manufacturing of semi-solid and non-sterile liquid drug products requires tight control over factors such as rheology, particle size, emulsion stability, and suspension stability to maintain dose uniformity and product performance at scale. Formulators must also manage microbiological quality in line with cGMP and USP microbial limits for non-sterile products, balancing preservative systems, packaging, and in-use conditions to keep bioburden within acceptance criteria. Robust process development, scale-up, and pharmaceutical process validation are therefore critical to ensure consistent quality and product performance across commercial batches.
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CPL operates an FDA- and Health Canada-regulated cGMP manufacturing facility that meets ccGMP requirements for facility design, cleaning, documentation, and data integrity. All commercial lines undergo formal equipment qualification, and processes are validated in accordance with the FDA’s lifecycle approach to process validation—process design, process qualification, and continued process verification. In-house USP testing, stability studies, and environmental monitoring support ongoing control, keeping commercial manufacturing inspection-ready and aligned with global regulatory standards. CPL’s quality and production teams work hand in hand to ensure quality on the floor.
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In the tech transfer process, CPL performs structured gap and risk analyses to compare sending-site and CPL equipment, CPPs, CQAs, analytical methods, and SOPs. Lab and pilot batches are used to confirm process robustness, followed by commercial-scale engineering and PPQ runs that support registration batch manufacturing and regulatory filings. Throughout, CPL links clinical batch manufacturing knowledge with commercial scale-up data to refine control strategies, de-risk launch, and enable reliable supply. Additionally, our tech transfer team works closely with our manufacturing and packaging operators to ensure a smooth knowledge transfer to the commercial floor.
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When selecting a pharmaceutical CDMO for commercial semi-solids and liquids, sponsors should prioritize:
- Deep experience in topical products and non-sterile liquid formulation, and commercial manufacturing
- Proven CDMO regulatory track record with FDA, EMA, and Health Canada
- Robust pharmaceutical tech transfer and process validation capabilities
- Integrated analytical development, product testing, and skin testing services (including IVRT/IVPT for topical products)
- Supply-chain robustness and KPIs such as OTIF performance
- Close relationship between quality and commercial teams to ensure on time, in full, in quality commercial production
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.
