Founded in 1942, Lannett is a leading pharmaceutical contract manufacturing company with over 75 years of experience partnering with clients on unique NDA products.
As a Contract Development and Manufacturing Organization (CDMO), we leverage our deep industry and technical knowledge to provide our clients with seamless risk mitigation in technology transfer, scale-up, and commercialization for high-quality pharmaceutical products with end-to-end solutions suited to each project’s needs.
Our experienced in-house team, manufacturing capabilities and services include:
Technology transfer expertise
for smooth transitions
Oral solid dose manufacturing
with 3.5 billion annual capacity
Liquid formulation production
(2.0M liters annually)
Scale-up and
commercialization support
Comprehensive analytical services
Dedicated project management
With a proven record of schedule attainment, as your strategic CDMO partner, Lannett is highly responsive to your needs, treating your products with the same care and precision as our own.
From formulation to production, our expertise supports pharmaceutical manufacturing with passion and dedication while maintaining the required regulatory compliance for CDMOs.
With a focus on seamless technology transfer and efficient solutions tailored to you, we’re dedicated to making your project a success, ensuring the highest standards from tech transfer to pharmaceutical manufacturing, packaging, and distribution.
Decades of Pharmaceutical
Manufacturing Success At Your Service
Bringing new pharmaceuticals to market takes more than just expertise. It takes a CDMO partner with the capabilities to support every stage and provide all your pharmaceutical contract manufacturing needs.
With a 400,000 sq. ft. facility, Lannett covers every stage of the production process. From the very first steps of your pilot scale, to tech transfer, scale-up and commercialization and beyond, through effective project management and communication, we build a lasting partnership throughout your product’s lifecycle.
High Capacity Pharmaceutical
Manufacturing for OSDs and Liquids
Whether it’s oral solid dose manufacturing or complex formulations, our CDMO partner services provide flexible, tailored solutions to meet your needs. Our state-of-the-art oral solid dose manufacturing facility with an annual capacity of 3.5 billion oral solid doses supports a wide range of formulations, including immediate release, extended release, and modified release technologies for tablets and capsules. We specialize in handling high-potency compounds and controlled substances I-V, with dedicated suites for potent drugs capable of managing compounds with OELs ranging from greater than 500 μg/m³ to as low as 0.1 μg/m³.
Scaling & OSD Manufacturing for Emerging Drug Markets
As pharmaceutical breakthroughs advance, complex oral formulations (such as oral and non-injectable GLP-1s) require specialized manufacturing facilities. Lannett CDMO’s reliable tech transfer, 3.5bn OSD capacity, proven scale-up expertise, production partnership, and regulatory expertise are positioned to bring new weight management therapeutics to market, quickly and effectively.
Technology Transfers and Risk Mitigation for Oral Solids and Liquids
Seamless scale-up from pilot to commercial scale
Modified Release Technology
Potent compound manufacturing (Category 1-3B, OELs to 0.1 μg/m3)
Complex Formulations and Reformulation Capabilities
DEA Schedule I-V handling with specialized vault storage
Controlled Substances
Advanced containment systems for high-potency formulations
Dedicated suites for high potent drugs
Reliable Regulatory
Compliance Procedures
Navigating regulatory compliance for CDMOs requires meticulous attention to detail. We offer comprehensive regulatory support, including CMC guidance, preparation of documentation, and post-approval product management. Lannett provides the confidence you need in a strategic pharmaceutical contract manufacturing partner. With Lannett as your CDMO partner, we provide the knowhow for regulatory submissions and FDA requirements for new drug approvals – all under one pharma contract manufacturing roof.
Technology Transfer You Can Trust
Our approach to tech transfer emphasizes quality, efficiency and speed to completion. With proven Contract Development and Manufacturing Organization procedures tailored to each product’s unique challenges, we ensure the fastest, most efficient tech transfer with the highest probability of technical, regulatory success, and commercial manufacturing. Lannett CDMO’s risk mitigation in technology transfer methodology minimizes disruptions while maintaining strict quality standards.
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