Rx Generic Semi-Solid & Liquid Drug Products
Complex Generics Backed by Regulatory and CMC Expertise
From program start through commercial launch, CPL helps sponsors navigate the unique challenges of Rx generic semi-solid and non-sterile liquid products. Our teams understand ANDA and international filing requirements, as well as the demands of bioequivalence studies. We provide reverse engineering, formulation optimization, scale-up, validation, and packaging to help you secure approvals and sustain a reliable supply in competitive markets worldwide.
Regulatory, Quality & Bioequivalency Support for Generic Semi-Solid and Liquid Products
Across development, registration, and post-approval change, CPL integrates regulatory strategy, quality systems, and bioequivalence (BE) expertise. We help interpret global expectations, generate defensible data, and turn complex product characterization and BE requirements into streamlined submissions.
Generic Semi-Solid and Non-Sterile Liquids Regulatory Support
While specific terminology varies among leading global regulators, they are aligned on a core framework. CPL’s regulatory and CMC teams interpret and apply U.S. ANDA expectations, Health Canada ANDS requirements, to generic semi-solid and non-sterile liquid products. We translate Q1/Q2/Q3 sameness, bioequivalence, and microbiological guidance into practical development and filing strategies, helping you prepare robust dossiers, respond effectively to questions, and maintain compliance throughout the product lifecycle for launches, line extensions, and post-approval changes across markets.
Bioequivalence Strategy, Study Design & Execution Support
CPL’s Skin Lab scientists help sponsors design bioequivalence (BE) strategies for generic semi-solid and non-sterile liquid products, leveraging the FDA’s SUPAC-SS framework for in vitro release testing (IVRT) and in vitro permeation testing (IVPT). Updated in 2022, these guidelines enable therapeutic equivalence assessments that can replace in vivo studies when formulations are truly Q1/Q2/Q3 aligned. We support reference formulation replication, IVRT method development and validation, and interpretation of release-rate data to demonstrate bioequivalence and streamline global submissions and post-approval change evaluations.
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Analytical Method Development Expertise Enables Smooth Regulatory Filings
For generic semi-solid and non-sterile liquid products, robust analytical methods are central to demonstrating Q1/Q2/Q3 sameness and bioequivalence. CPL develops and validates stability-indicating, discriminating methods that can distinguish meaningful formulation and process changes while aligning with pharmacopeial and ICH expectations. Our teams support core product characterization and microbiology testing, as well as methods used for IVRT/IVPT and BE studies. The result is clean data packages, fewer regulatory questions, and smooth ANDA and ANDS submissions.
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Product Testing Expertise Ensures Compliance
Rigorous product testing is essential to confirming Q1/Q2/Q3 sameness, bioequivalence, and ongoing compliance. CPL designs release and stability programs that align with pharmacopeial, ICH, and regional requirements for ANDA and ANDS submissions. Our laboratories support comprehensive product and microbiological testing, as well as methods used in IVRT/IVPT studies. Robust, well-documented data packages help minimize regulatory questions and sustain compliance across the product lifecycle.
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Packaging, Labeling, Serialization & Aggregation
CPL’s primary and secondary packaging for semi-solids and non-sterile liquids is fully integrated with our clinical and commercial manufacturing, combining precision filling with flexible formats for tubes, bottles, and foil sachets. Fully integrated tube and bottle lines, plus two portable serialization systems, enable coding, verification, and aggregation at the carton, bundle, case, and pallet levels across all packaging lines. 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.
Explore Packaging, Labeling & Serialization CapabilitiesCPL Experience Spotlight
IVRT and API Distribution Challenges for Topical Generic Launch Solved
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 specialized pharmaceutical CDMO focused on liquid and semi-solid dosage forms, offering cGMP manufacturing for ointments, creams, lotions, gels, oral solutions and suspensions, and sprays. We combine robust pharmaceutical formulation development with late-stage scale-up, commercial manufacturing pharma capabilities, and DSCSA serialization. Sponsors rely on CPL as a CDMO with a strong regulatory track record, dependable clinical supply and commercial supply, and deep experience navigating ANDA pathways.
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CPL manages pharmaceutical technology transfer end-to-end, from reverse engineering and lab-scale formulation development for creams, gels, ointments, and liquids through clinical batch manufacturing and commercial-scale manufacturing. Utilizing our 9-point tech transfer strategy, we routinely transfer semi-solid and liquid manufacturing solutions from other CDMOs, de-risking the tech transfer process while preserving product performance, stability, and regulatory alignment.
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CPL’s pharmaceutical analytical services and microbiological quality control (QC) testing support our customers with generic non-sterile liquid and semi-solid products. Our validated methods support both release and ongoing stability storage services in controlled conditions, including handling light-sensitive products. We integrate pharmaceutical process validation, equipment qualification, and serialization/track-and-trace (including DSCSA and packaging serialization) to create a compliant, inspection-ready control strategy. The result is Rx generic ointments, creams, gels, oral suspensions, and liquid pharmaceuticals that consistently meet global regulatory expectations throughout the product lifecycle.
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CPL develops and manufactures a wide range of generic semi-solid and non-sterile liquid dosage forms, including creams, ointments, gels, lotions, oral solutions, suspensions, and topical sprays. Our flexible packaging capabilities accommodate tubes, bottles, foil sachets, and other specialized formats, including options for tamper-evident, child-resistant, and airless closures. We support DSCSA serialization and aggregation across primary and secondary packaging lines, helping customers maintain compliance while customizing packaging solutions to suit market and regulatory needs.
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.
