Commercialization & Commercial Supply
From Late-Phase Readiness to Reliable Commercial Supply
As products transition from Phase II/III into launch and beyond, CPL tightens every aspect of the process so semi-solid and non-sterile liquid drug products are truly commercial-ready. We lock in formulations, CPPs (Critical Process Parameters), and CQAs (Critical Quality Attributes), and execute registration, PPQ (Process Performance Qualification), and commercial validation batches under cGMP. Integrated analytical method validation, stability programs, and in vitro skin testing feed robust CMC packages for NDA, ANDA, and 505(b)(2) filings. At the same time, our proven manufacturing, packaging, and supply chain capabilities support dependable, inspection-ready commercial supply.
Integrated Commercial-Phase Control for Semi-Solids & Liquids
As products move through registration, launch, and routine supply, CPL unites formulation, process, analytical, and product-testing expertise to ensure robustness, support PPQ and registration batches, and sustain reliable commercial manufacturing.
Commercial Product & Formulation Optimization
In the commercial phase, CPL focuses on tightening and maintaining semi-solid and non-sterile liquid formulations for long-term success. We refine compositions based on clinical, stability, and manufacturing data, confirm robustness at commercial scales, and mitigate any remaining risks. By aligning formulation decisions with CPPs and CQAs, we help sponsors finalize durable, registration-ready formulations that perform consistently batch after batch.
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Process Characterization & PPQ
For commercial readiness, manufacturability means proven, reproducible performance over time. CPL characterizes processes for semi-solids and non-sterile liquids, maps CPPs to CQAs, executes engineering and PPQ batches, and tightens controls ahead of launch. We resolve process and any final product containment challenges, translate processes to commercial lines, and align master batch records, documentation, and risk assessments with cGMP and regulatory expectations to support smooth inspections and approvals.
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Registration Support & Commercial Product Testing
CPL’s analytical and microbiology laboratories deliver the comprehensive release, stability, and performance testing required for registration and commercial supply. We design and run ICH-aligned stability programs, comparability studies, and in vitro skin testing to support established shelf life, lifecycle management, and bioequivalence for generic products. All data are generated under cGMP and structured for seamless inclusion in CMC sections of NDA, ANDA, and 505(b)(2) filings, helping sponsors maintain compliance and navigate post-approval changes with confidence.
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Registration & Commercial-Scale Manufacturing
Our registration and commercial manufacturing services create a reliable bridge from late-phase development to sustained market supply for semi-solid and non-sterile liquid drug products. With batch sizes from 20kg to 5,000kg, we support PPQ and registration batches, launch stock, and ongoing commercial production under rigorous cGMP. Our 35-year experience with topical, nasal, and oral liquid formulations, combined with integrated packaging, serialization, and resilient supply chain management, ensures every batch meets regulatory expectations and market demand from launch through long-term lifecycle management.
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Packaging, Labeling, Serialization & Aggregation
At the commercial stage, packaging teams for non-sterile liquids and topicals must handle difficult-to-fill products while meeting global requirements for unit-level serialization, tamper-evident features, and full traceability under US DSCSA and EU FMD. CPL integrates bulk drug manufacturing with advanced packaging, labeling, serialization, and aggregation to deliver turnkey, cGMP-compliant solutions that de-risk launches, strengthen supply chain security, and help ensure uninterrupted global supply.
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Procurement, Planning, Scheduling & Warehousing
From the earliest forecast, CPL’s supply chain team manages raw materials, components, and packaging from vendor qualification and sourcing through receipt, testing, and release. Integrated planning and scheduling align inventory with production campaigns, while GMP-compliant warehousing, segregation, and environmental controls protect excipients, APIs, and packaging. The result is dependable, material management that supports true OTIF performance for semi-solid and non-sterile liquid programs.
Explore Commercial Manufacturing CapabilitiesCPL Experience Spotlight
Sampling Strategy Collaboration Increased Product Sales
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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CPL is a specialist pharma CDMO focused on semi-solids and non-sterile liquids, providing commercial-scale GMP manufacturing for creams, ointments, gels, lotions, solutions, suspensions, nasal sprays, and other liquid pharmaceuticals. Services include registration and PPQ batches, routine commercial production, packaging and labeling, serialization and aggregation, ongoing stability programs, and lifecycle support for NDA, ANDA, and 505(b)(2) products.
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Commercial manufacturing builds on late-phase process characterization and PPQ. CPL maps CPPs to CQAs, locks in validated processes and cleaning protocols. Detailed master batch records, risk assessments, and cGMP documentation support smooth inspections, continued process verification, and long-term compliance for semi-solid and non-sterile liquid manufacturing.
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We perform fully validated analytical methods (ICH Q2) and ICH-aligned stability programs to support ongoing release testing, annual stability testing, and comparability for post-approval changes. QC testing covers assay, related substances, content uniformity, viscosity, pH, particle size, microbial limits, and in vitro skin testing ( IVRT/IVPT). CPL has a 35-year history of producing data packages structured to support CMC updates, supplements, and global regulatory commitments.
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Our team combines validated commercial manufacturing with robust supply chain management, container closure expertise, and fully integrated primary and secondary packaging. Our packaging, labeling, serialization, and aggregation capabilities comply with US DSCSA and EU FMD using GS1-aligned standards. By aligning procurement, inventory, and OTIF-focused scheduling with cGMP production, CPL helps sponsors maintain uninterrupted global supply while protecting patients and deterring counterfeits.
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.
