Oral Solid Dose (OSD) Manufacturing
We deliver excellence
Selecting the right cGMP contract manufacturer to produce your oral solid dosage form is a crucial decision. CordenPharma is your CDMO partner of choice, trusted by pharmaceutical innovators worldwide for quality, flexibility, and speed across the entire drug lifecycle.
Trusted partner in OSD development and manufacturing for over three decades – from early development to global commercial supply.
Full lifecycle support for OSD drug products, from early-phase formulation and clinical supply to late-stage validation and commercial manufacturing.
Advanced solutions for complex OSD challenges, including the safe handling of Highly Potent APIs (HPAPIs), oral peptides, and bioavailability enhancement technologies like Spray Drying and Hot Melt Extrusion.
Highly experienced project management and Manufacturing Science & Technology (MSAT) teams ensure seamless technology transfer and efficient project execution from development to commercial scale.
Our expert OSD teams have successfully delivered multiple OSD projects, ranging from First-in-Human studies to filing, market launch and supply.
International logistics, regulatory know-how and serialization capabilities across our fully-inspected GMP facility network enable compliant distribution to more than 70 countries.
Our OSD Approach
Move Your OSD Projects from Development to Commercialization with Confidence
Whether you’re launching a new molecule or scaling an existing formulation, move with confidence from early development to market.
CordenPharma provides expert OSD guidance and execution across every phase, including preclinical and clinical supply, late-stage validation, full-scale manufacturing and packaging. By incorporating biopharmaceutic principles for early-phase formulation screening, compatibility for formulation development, as well as performance and scalability, process development, tech transfer, and characterization to reach filing readiness, our experts support your molecule to successful market launch.
Fast & Flexible from Concept to Prototypes
When early-stage drug candidates need a viable solid oral formulation, time and precision are critical. CordenPharma rapidly develops tailored prototypes to meet preclinical and First in Human (FIH) study requirements.
Once your candidate demonstrates promise in preclinical models, our formulation and manufacturing experts step in to support you with Investigational New Drug (IND) / Investigational Medicinal Product Dossier (IMPD) applications to bridge the gap between discovery and First-in-Human trials.
Dive deeper to explore CordenPharma’s full early-phase offering: Download PDF
Drug Product for First-in-Human Trials
Getting a product into FIH clinical Phase I studies in a flexible, fast, and efficient manner is critical. We offer an initial developability assessment that includes API profiling and technology selection (conventional, bioavailability enhancing), phase-appropriate formulation development, and prototype preparation.
By applying stability predictions using the Accelerated Stability Assessment Program (ASAP) methodology, characterization with biorelevant dissolution, and comprehensive physical testing, our Drug Product Innovation Centre of Excellence rapidly determines the optimal prototype, enabling efficient manufacturing and swift progression of your product into FIH studies.
Our structured approach encompasses:
Small samples of formulation concepts can be provided for exposure testing. After completion of preclinical investigations, the selected prototype(s) is developed to the final dosage form for clinical trial material supply.
One challenge in FIH studies may be in identifying the appropriate dose range. Dose flexibility can be reached by different means, such as filling capsules with different volumes or quantities of API, powder / granules, pellets, or minitablets. Our encapsulation technology ensures that various dose strengths are available “on demand” during the clinical study. In parallel, phase-appropriate analytical methods will be qualified to ensure they are suitable for use in releasing all materials.
Capabilities & Technology
What state-of-the-art technologies does CordenPharma use for OSD? Our projects are backed by advanced infrastructure and technologies like spray drying, hot melt extrusion, and compaction simulators.
Our regularly-inspected manufacturing sites deliver oral solid dosage forms at the highest quality standards to world-wide markets. Commercial OSD forms and adaptable manufacturing technologies include:
Tablets, the most popular dosage form
Capsules of all sizes
Blending
Granulation
Coating of tablets
Our network provides scales and batches adapted to your needs, from small-scale niche products to large-scale blockbusters:
Dosage forms are supplied as bulk material or are packaged on-site. Our high-speed capabilities for primary and secondary packaging into bottles, blisters, and sachets deliver your drug products to markets according to your needs.
Global OSD Manufacturing Network
Fully cGMP-compliant facilities in Plankstadt (DE), Fribourg (CH), and Lisbon (PT), supporting small- to large-scale batches.
Tech Transfer & Analytical Support
For technology transfers, we follow a science driven, risk-based approach aligned with Quality by Design (QbD) principles, including risk assessment, gap analysis, and risk acceptance. Mitigation activities are carried out as needed – from small to full scale – using modelling, Design of Experiments (DoE), and comprehensive analytical and MSAT support.
Our comprehensive analytical capabilities, in-house technologies and in-place methodologies allow for fast turnaround times for compendial and specific API and dosage form testing:
Our Experience
From Complex Modalities to Commercial Success
We partner with pharma and biotech innovators to bring complex oral solid drug products safely and efficiently to market. With integrated teams, deep technical know-how, and decades of CDMO experience, we deliver solutions that scale – and succeed.
At CordenPharma, we don’t just offer services – we bring together science, compliance, and strategy to help our partners succeed with their OSD projects across every phase of development.
Dr. Oliver Schinzinger
Head of Global Pharmaceutical Development, CordenPharma
Our Drug Product Innovation Centre of Excellence provides dedicated teams of subject matter experts and highly specialized equipment to support smooth technology transfers and effective project management.
Embedded in our global pharmaceutical development network, the centre works in close collaboration with formulation scientists, analytical scientists, and Manufacturing, Science & Technology (MSAT) experts to provide strong process understanding that supports your successful OSD drug product development.
This unique combination of expertise with small-scale instrumentation (down-sized pieces of equipment from manufacturing), coupled with specialized equipment and analytical capabilities, is a valuable asset for risk mitigation activities, troubleshooting, and innovative formulation development:
Quality, Compliance & Regulatory
From first formulation design to final QP release (Qualified Person release) CordenPharma upholds scientific rigor, regulatory compliance, and the highest standards of quality throughout your project lifecycle
CordenPharma’s commitment to quality is anchored in a globally harmonized Quality Management System (QMS), ensuring full compliance with international regulatory authorities, including the FDA (US), EMA (Europe), and PMDA (Japan). Each facility within the network operates under the same high-level standards and is routinely inspected to maintain audit readiness.
To uphold and continuously improve these standards, CordenPharma invests in advanced quality-enhancing IT systems, regular internal and external audits, and comprehensive personnel training. These proactive measures guarantee that every product manufactured under the CordenPharma umbrella meets the highest requirements for safety, efficacy, and consistency.
Throughout the product lifecycle, documentation and data integrity remain core pillars of CordenPharma’s quality assurance strategy. From early-phase development through commercial supply, all activities are developed and validated in alignment with regulatory requirements for Chemistry, Manufacturing & Controls (CMC) dossiers.
Our experienced teams deliver regulatory-ready CMC packages, comprehensive documentation tailored for submissions in global markets.
Regulatory experts located at each manufacturing site manage the data to support Centralized Marketing Authorization procedures, and handle jurisdiction-specific compliance matters with agility and precision.
CordenPharma’s quality approach is strengthened by a highly experienced, global Project Management (PM) team. With over 60 specialists across the network, our Project Managers serve as the single point of contact for clients – coordinating all technical, regulatory, and logistical aspects of a program.
Their role includes:
The PM team follows global SOPs to guarantee consistency, compliance, and speed-to-execution across every project – minimizing risk and ensuring a successful pathway from development to market.
FAQs
Your questions, answered. We know selecting the right CDMO partner is critical. Explore answers to common questions about our oral solid dose development and manufacturing services.
We manufacture a broad range of oral solid forms including tablets, minitablets, capsules, pellets, granules, and powders for reconstitution and package them in bottles, blisters or sachets. Pediatric and modified-release formats are also supported.
Yes. CordenPharma provides a comprehensive solution for oral peptide development, covering everything from initial concept screening and formulation development to GMP manufacturing, using innovative strategies to improve drug properties and absorption. This includes a seamless transition from small-scale samples to large-scale commercial production of oral solid dosage forms. Find out more
Yes. Our OSD sites include dedicated containment areas for handling HPAPIs with occupational exposure limits (OEL) < 0.05 µg/m³. All HPAPI operations follow strict GMP and containment protocols.
Yes. We offer rapid, flexible support for phase I development, including API profiling, formulation screening, and prototype development using developability assessment and considering biopharmaceutic principles. Our technologies enable adjustable dose strengths and fast turnaround for First-in-Human trials.
All CordenPharma OSD sites are fully cGMP-compliant and have been successfully audited by global health authorities including the FDA, EMA, PMDA, and others.
Our experienced MSAT and project management teams enable rapid, low-risk technology transfers through a data driven risk based apporach following QbD principles, including predictive process modeling and scale-down experimentation, all under an umbrella of global and harmonized SOPs.
We offer both dry and wet granulation technologies, including dry granulation by roll compaction and wet granulation using high shear mixing and fluid bed granulation, followed by drying (fluid bed or tray drying). These methods are fully scalable from development through to commercial production.
Yes. We develop a wide range of pediatric-friendly oral solid forms, including mini-tablets, granules, pellets, dry syrups, and orally disintegrating tablets. Our capabilities also include taste masking and low-dose tablets or capsules tailored for safe and effective administration in children.
Yes. We support moisture-sensitive drug products in controlled packaging environments. Our automated blister and bottle packaging lines also support requirements like serialization, aggregation, tamper evidence, and unit-dose protection. Plus, our logistics solutions include cold chain shipping, global customs handling, and secure warehousing to maintain your product integrity from factory to patient.
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