Packaging, Labeling, Serialization & Aggregation
Integrated Commercial Packaging Solutions for Semi-Solids and Non-Sterile Liquids
Packaging teams for non-sterile liquids and topicals are challenged by often difficult-to-fill drug products and face increasing complexity as global regulations such as the US DSCSA (Drug Quality and Security Act) and the EU FMD (Falsified Medicines Directive) require unit-level serialization, tamper-evident packaging, and traceability to combat counterfeit medicines and secure supply chains.
CPL’s comprehensive packaging, labeling, serialization, and aggregation capabilities, when coupled with our bulk drug manufacturing capabilities, offer turnkey solutions that de-risk programs and ensure continuity of supply.
Primary & Secondary Packaging for Semi-Solids and Non-Sterile Liquids
- Precision Filling
- Primary & Secondary Packaging
- Flexible Formats
CPL’s primary and secondary packaging solutions are fully integrated with our clinical and commercial manufacturing, offering precision filling and highly flexible packaging formats. Automated and semi-automated lines handle tubes, bottles, and foil sachets, with options such as nitrogen blanketing, intrinsically safe (XP) lines, and specialized closures, including dropper tips, pumps, airless and child-resistant caps, overcaps, and more. Primary packaging flows seamlessly into secondary packaging, including cartoning, inserts, labeling, and tamper-evident features, all under cGMP-compliant control and on-site QC to support efficient, compliant supply for our global customers.
Serialization & Aggregation for Secure, Compliant Supply Chains
- DSCSA & EU FMD Compliance
- GS1-Aligned Standards
- Flexibility
We provide end-to-end serialization and aggregation solutions that ensure global compliance and supply chain security. We meet US DQSA and DSCSA (Drug Supply Chain Security Act) expectations, as well as EU FMD requirements, using GS1-aligned standards and proven platforms such as TraceLink, Optel, and Loftware.
Fully integrated solutions on our tube and bottle lines, plus portable serialization systems, enable coding, verification, and aggregation at the carton, bundle, case, and pallet levels across all packaging lines. Our serialization-ready infrastructure includes the necessary hardware and software and integration with customer and distribution networks, protecting patients, deterring counterfeiting, ensuring compliance, and providing the flexibility clients require.
Proven Global Compliance and Inspection Readiness
Regular inspections by the FDA, Health Canada, 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.
CPL Experience Spotlight
Integrated Manufacturing & Packaging Operations Delivered Increased Efficiency
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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An expert pharmaceutical CDMO should offer GMP manufacturing and packaging lines designed explicitly for semi-solids and liquids, such as ointments, creams, lotions, gels, oral suspensions, nasal sprays, and topical sprays, with proven control over filling accuracy and rheology. For topical products, regulators expect suitable container-closure systems that protect the product, maintain stability, and support correct dosing. Robust artwork control, labeling meeting the compliance requirements of leading global regulators, and inspection-ready documentation round out best-in-class packaging and labeling services.
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Under the U.S. Drug Supply Chain Security Act (DSCSA), most prescription drug packages and cases must carry a unique product identifier, typically encoded in a 2D data matrix barcode, supporting package-level serialization and interoperable electronic track-and-trace. For sponsors of semi-solid and non-sterile liquid products, this means packaging serialization and aggregation must be built into commercial and late-stage clinical supply manufacturing. A capable pharma CDMO provides end-to-end pharmaceutical serialization services for DSCSA, EU FMD safety features, and global markets, integrating line-level equipment and compliant data exchange to support secure supply chains.
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Aggregation is the process of linking uniquely serialized saleable units (e.g., cartons) to the bundles, cases, and pallets that contain them, creating a “parent–child” hierarchy in the serialization database. This enables track-and-trace serialization with a single scan at the case or pallet level, dramatically speeding distribution and returns processing. For commercial manufacturing in the pharma industry, accurate aggregation is critical for DSCSA and EU FMD compliance, efficient wholesale operations, and rapid investigation of recalls or diversion. A mature CDMO uses validated aggregation systems to maintain data integrity across the entire supply chain.
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In a cGMP manufacturing environment, packaging and serialization equipment undergo formal equipment qualification in the pharmaceutical industry—Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)—to demonstrate they are installed correctly, operate as intended, and perform reliably under routine conditions. These machine-qualification activities feed into broader process validation, confirming that packaging, labeling, and serialization processes consistently meet predefined critical quality attributes. For sponsors, this means documented risk assessments, alarms and rejection logic, container-closure integrity checks, and audit-ready validation packages support commercial-scale and clinical batch packaging runs.
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.
