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Partnering with a trusted Contract Development and Manufacturing Organization (CDMO) is critical for pharmaceutical and biotech companies aiming to scale production, ensure regulatory compliance, and accelerate time-to-market.
Lannett CDMO provides end-to-end pharmaceutical manufacturing solutions designed to meet the needs of both small biotech innovators and large pharmaceutical firms. Our integrated services include:
Each project is supported by a cross-functional team with expertise in regulatory guidance, supply chain coordination, and technical problem-solving. This comprehensive service model enables partners to move efficiently from concept to compliant, market-ready product.
Founded in 1942, Lannett Company, Inc. is a leading pharmaceutical contract manufacturing company with over 75 years of experience partnering with clients on unique NDA products.
The CDMO division was formalized in 2022 to serve big pharma partners seeking U.S.-based manufacturing. Lannett operates a single 400,000 sq ft facility in Seymour, Indiana, providing end-to-end services from sclae-up to commercial manufacturing, fill/finish, packaging, and commercial distribution.
Lannett CDMO leverages deep industry and technical knowledge to provide seamless risk mitigation in technology transfer, scale-up, and commercialization for high-quality pharmaceutical product manufacturing with end-to-end solutions suited to each project’s needs.
Lannett provides technology transfers and risk mitigation for oral solids and liquids, modified release technology, complex formulations, and specialized handling of controlled substances, and Potent Compounds.
Looking for a reliable, reputable pharmaceutical contract manufacturing company with a track record of quality and excellence?
Discover Lannett CDMO’s manufacturing capabilities:
https://www.lannettcdmo.com/manufacturing-supply-chain/
Lannett’s state-of-the-art manufacturing facility in Seymour, Indiana spans approximately 400,000 square feet on a 30-acre site, covering every stage of the production process.
Our all in one integrated facility location encompasses:
This single-site approach eliminates transfer delays and ensures consistent quality from pilot scale through tech transfer, scale-up, and commercialization.
Our liquid manufacturing ensures homogeneity, palatability, and stability, offering precise dosing for pediatric and geriatric care across a range of therapeutic categories.
We offer expertise in High potency compounds at OEB 3 and OEB 4-5 levels.
For emerging biotech companies, rapid scale-up is a challenge — balancing scientific innovation with manufacturing precision.
Lannett CDMO bridges that gap by providing flexible production capacity, GMP-certified facilities, and tech transfer expertise that allows biotech firms to transition from lab to commercial readiness without compromising quality.
Our agile development model supports pilot-scale batches, formulation optimization, and data-driven process validation for manufactured pharmaceutical products.
We offer manufacturing services for specialized formulations including oral and non-injectable GLP-1 drug production, addressing the growing market for weight management therapeutics.
With reliable tech transfer processes, 3.5 billion OSD capacity, proven scale-up expertise, and comprehensive regulatory support, we bring new therapeutics to market quickly and effectively.
From late-stage formulation optimization, Lannett CDMO’s formulation development services cover both new chemical entities and complex generic products.
Our scientists specialize in improving bioavailability, enhancing stability, and optimizing drug release profiles.
Ready to accelerate your product development?
Contact Our Team: https://lannettcdmo.com/contact-us
Quality and compliance are at the core of Lannett CDMO’s operations.
All facilities are FDA-inspected and cGMP-compliant, with stringent Quality Management Systems (QMS) in place for each manufacturing stage.
Our QA and regulatory teams ensure:
This rigorous approach ensures that every product meets the highest standards of safety, efficacy, and regulatory readiness.
Lannett provides regulatory documentation support and helps clients prepare data packages for FDA, EMA, and ICH-compliant submissions, simplifying the approval pathway for complex drug products.
Our analytical services ensure that every formulation and batch meets rigorous scientific and regulatory benchmarks. Capabilities include:
Need analytical testing or stability studies?
Request an Analytical Services Quote from Lannett CDMO:
https://lannettcdmo.com/contact-us
Lannett CDMO supports global clinical trials with reliable supply chain continuity and controlled distribution of investigational materials.
Our logistics and operations teams manage labeling, storage, and cold chain shipping, ensuring consistency across global study sites.
We focus on maintaining supply timelines and batch integrity to help sponsors meet crucial clinical milestones with confidence.
All packaging lines feature serialization capabilities, online weight checking, and in-line vision systems to detect and reject defective units. OSD lines include online electronic labeling inspection for DSCSA compliance.
Our VAWD-accredited distribution network provides domestic and global distribution capabilities, including specialized vault and cage storage for DEA substances, freezer and cooler capabilities for temperature-sensitive products, and established logistics to serve North America, Europe, and Asian markets.
If you need a trusted clinical trial drug manufacturer who can scale from to commercial supply chain management with end-to-end pharma regulatory support that ensures compliance with FDA regulations and requirements, connect with Lannett CDMO: https://www.lannettcdmo.com/contact-us/
U.S.-based CDMOs offer distinct advantages for North American market access.
What Top CDMOs Possess:
The single-site U.S. facility approach provides seamless processes, direct FDA communication, simplified regulatory pathways, and faster distribution to North American markets compared to international alternatives.
By combining technical depth with responsive collaboration, Lannett CDMO ensures your project moves efficiently — from molecule to market.
Explore how Lannett CDMO can support your project: https://www.lannettcdmo.com/resources/your-guide-to-lannett-cdmo/
Lannett CDMO analytical testing, and commercial manufacturing to deliver seamless support across every development phase —to global market supply.
Ready to accelerate your pharmaceutical development program?
Connect with our experts to explore customized CDMO solutions that meet your scale, compliance, and commercialization goals.
Request a Quote
CDMO@lannett.com
Download Corporate Brochure
https://www.lannettcdmo.com/resources/your-guide-to-lannett-cdmo/
Contact Lannett CDMO
https://www.lannettcdmo.com/contact-us/
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