Cosette CDMO combines long-standing pharmaceutical expertise with the flexibility of a dedicated manufacturing partner. Our teams manage production and packaging for complex dosage forms, maintaining the same precision and control that guide Cosette’s own portfolio. The focus is always on quality, efficiency and dependable delivery. We understand development and supply because we manage them ourselves. That experience shapes how we work with clients and how products reach patients.
Why ChooseCosette CDMO?
Cosette CDMO is a partner grounded in pharmaceutical practice and built for long-term reliability.
We offer proven systems, experienced people and a collaborative approach that keeps projects moving.
EmbeddedPharmaceutical Expertise
Cosette CDMO launched in 2018 to make our internal expertise available to partners. We support semi-solids, liquids, suspensions and suppositories, applying the same quality systems that guide our own medicines.
Our aim is straightforward: dependable, compliant delivery from transfer through commercial supply.
Proven Capability Across Complex Dosage Forms
Cosette’s facilities support end-to-end processes for challenging formulations.
With over 30 years of operational success and a proven regulatory track record, Cosette blends large-scale infrastructure with the responsiveness of a specialized CDMO. We manage formulation development, scale-up, packaging, stability testing and commercial release under one unified quality framework – ensuring smooth progression from R&D through commercial production.
Core Dosage Forms
Semi-solids
Creams, gels, ointments, lotions, shampoos
Liquids
Oral solutions and suspensions
Suppositories
One of the largest manufacturing operations in the U.S.
Manufacturing Capability Across Key Dosage Forms
Cosette specializes in dosage forms that demand technical skill and process stability.
Our facilities support commercial manufacturing of semi-solids, liquids, suspensions and suppositories, using equipment and controls designed for consistency at every scale.
Production spans pilot through full-scale campaigns, giving clients a single partner from transfer to commercial supply. Each batch follows defined processes for uniformity, yield and traceability.
Flexible operations that adapt to each product
Every product behaves differently during manufacturing, so each process is built to fit its physical and chemical profile.
Engineering and operations teams adjust parameters and validate changes to maintain throughput and reproducibility. The result is stable performance across runs and reliable timelines for release.
Projects benefit from continuous contact between Manufacturing, Technical Services and Quality, keeping reviews active and issues visible until every requirement is met.
Our team has the expertise to modify, purchase, and qualify equipment to meet a client's exact needs.
- Mark Campbell, Director, EH&S, Engineering & Facilities Maintenance
Integrated Packaging Services
Packaging operations are part of the same quality system that governs manufacturing. Cosette handles bottles, tubes and suppository formats, supported by serialization and controlled storage for temperature-sensitive products.
Each configuration is validated for integrity, presentation and compliance before release. The packaging group works directly with Manufacturing and Quality to shorten change-control cycles and maintain full product traceability through distribution.
Additional strengths include:
- DEA Schedule II–V license for controlled substances
- In-house stability programs and environmental control
- Flexible labeling, cartoning, and shipping solutions
Technical Services: Practical Expertise That Scales
Technical Services is the bridge between development and reliable manufacturing.
The team reviews incoming documentation, designs and qualifies processes, and manages validation through to commercial readiness. Cleaning and equipment qualification, alternate-material assessment and process optimization ensure each line runs efficiently and meets required standards.
Every program is handled with ownership and attention. Clients receive consistent communication and transparent reporting so that challenges are identified and resolved quickly.
We treat every product like our own. The same procedures, the same quality mindset — every time.
- Nihar Desai, Vice President, 3rd Party Operations
Quality and Reliability
Are Our Foundation
Our quality systems are embedded across development, technical services and manufacturing.
We operate to cGMP standards across every client program. Every process, investigation and
validation follows the same standards that guide our own commercial products.
Quality built into every stage
Quality oversight runs through every activity at Cosette. The group manages cGMP documentation, investigates deviations and leads continuous training so that standards stay consistent across teams. Quality decisions are based on data, supported by clear records and verified methods that maintain control and traceability.
Collaboration that drives consistency
Technical Services and Quality collaborate closely from feasibility through validation, ensuring no decision is made in isolation. Quality is engaged early during product assessment and equipment planning. Joint reviews across Technical Services, Operations, and Quality maintain alignment, while regular client touchpoints promote transparency and trust.
The result is a partnership that balances scientific precision with practical agility, minimizing risk and accelerating progress toward commercialization.
Quality isn't a step in the process; it's the foundation of every decision.
- Cindy Reid, VP, Quality Assurance
Corporate Headquarters and Manufacturing U.S. Facility Designed for Efficiency and Scale
Both sites operate to cGMP standards and maintain the infrastructure needed for reliable, traceable manufacturing.
Bridgewater, New Jersey -Corporate Headquarters
Serving as the central hub for our corporate leadership, quality, regulatory, sales, business development, and commercial operations. Our Bridgewater location anchors our commitment to innovation, operational excellence, and customer partnership across our CDMO network.
Lincolnton, North Carolina -Manufacturing Hub
Spanning 12 acres and over 150,000 sq. ft., Lincolnton is the center of Cosette’s manufacturing operations. The facility brings together over 250 specialists who produce semi-solids, liquids, and suppositories at commercial scale, with integrated packaging, warehousing and controlled-storage operations that keep supply dependable and compliant.
Capabilities include
- Commercial scale dosage forms – creams, gels, ointments, lotions, shampoos, oral liquids (solutions and suspensions) and suppositories
- Technical capabilities include process optimization, technical transfer process support, product remediation, and reformulation
- Facility operates a full-service quality control laboratory, including chemistry and microbiology, as well as method development and validation capabilities
- Drug Enforcement Administration(DEA) – Schedule II through V (Raw materials and Finished goods)
- XP capabilities – Class I / Div. I
- Cold storage – 2 to 8 Celsius (Raw materials and Finished goods)
- End-to-end supply within Cosette’s U.S. network
A Partner That SharesYour Priorities
As part of an established pharmaceutical organization, we know every product represents a patient outcome. We bring the same care, accountability, and urgency to client programs as we do to our own.
Partnering with Cosette means gaining a team that:
- Applies decades of pharmaceutical experience to every project
- Maintains the highest standards of regulatory compliance and ethics
- Communicates openly and acts as an extension of your own organization
Working with Cosette CDMO means your intellectual property (IP) stays protected, your product is prioritized and your timelines are respected. A dedicated project manager keeps progress visible at every stage and patient-first decision-making drives every milestone.
Ready to Bring Your Product to Life?
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