Business Details
CDMO for Controlled Drug Delivery Systems in GA
Osmotica USA is a full-service CDMO specializing in controlled and modified drug delivery systems, with a legacy of innovation dating back to the early 1980s. Our FDA-inspected facility in Marietta, Georgia, combines technical expertise in extended and modified release technologies with a commitment to advancing patient care. As pioneers of laser drilling and Osmotic Technology, we provide end-to-end solutions from development to commercial manufacturing, supported by robust analytical capabilities. Our history includes strategic acquisitions, such as the 2011 purchase of the Marietta site from Solvay/Abbott and the 2016 merger with Vertical/Trigen Pharmaceuticals. With over $40 million invested in facility enhancements and a team of industry veterans, we deliver high-quality pharmaceutical solutions tailored to unmet medical needs.Our leadership team brings decades of experience in pharmaceutical innovation, regulatory compliance, and global market expansion. We prioritize patient-centric approaches, evidenced by our clinical development of approved NDAs like Allegra D and Osmolex ER. Our partnerships with organizations like Avista Capital Partners and Lantheus Holdings underscore our industry authority. Committed to E-E-A-T principles, we maintain transparency in operations, adhere to ethical standards, and focus on client satisfaction through personalized service. Our global impact is reflected in our commercial manufacturing capabilities and ongoing Phase III clinical trials for candidates like arbaclofen ER.
Services
CDMO Services
Clinical Trials
Drug Delivery Systems
Research & Development
Commercial Manufacturing
Highlights and features
- We offer FDA-inspected manufacturing facilities with 40+ years of industry experience.
- Our proprietary Osmodex technology enables precise drug release modulation.
- We specialize in extended and modified release formulations for complex therapies.
- Our team includes veterans from leading pharmaceutical companies like Novartis and Bristol-Myers Squibb.
- We maintain a 200,000 sq. ft. facility with $40M+ in recent capital investments.
Associations and certifications
- FDA
Services
CDMO Services
We provide end-to-end contract development and manufacturing for controlled-release pharmaceuticals. Our services include formulation development, analytical testing, and commercial-scale production using patented technologies. Clients benefit from FDA-compliant processes and expertise in scaling from clinical to market-ready quantities.
Clinical Trials
Our clinical trial programs focus on reformulated compounds for improved therapeutic outcomes. We conduct Phase III trials for candidates like arbaclofen ER, targeting unmet medical needs in neurology and pain management. Our team ensures compliance with global regulatory standards for trial design and data submission.
Drug Delivery Systems
We specialize in proprietary Osmodex technology for modulated drug release profiles. This includes extended, delayed, and combination-release formulations that enhance efficacy and reduce side effects. Our systems are applied to both small molecules and complex biologics.
Research & Development
Our R&D team focuses on reformulating existing drugs for improved therapeutic attributes. We leverage expertise in pharmaceutics and clinical pharmacology to develop bioequivalent alternatives and novel indications, supported by a pipeline of Phase III candidates.
Commercial Manufacturing
We offer large-scale manufacturing of approved pharmaceuticals using cGMP-compliant processes. Our 200,000 sq. ft. facility includes dedicated lines for high-potency compounds and temperature-sensitive formulations, ensuring quality across all production batches.
People
Brian Markison
Chairman & CEO
Healthcare executive with 30+ years in pharmaceutical leadership, including roles at Fougera Pharmaceuticals and King Pharmaceuticals. Serves on multiple industry boards and holds a B.S. from Iona College.
Tina deVries
EVP, Research & Development
Pharmaceutics expert with prior leadership roles at Actavis and Warner Chilcott. Holds a Ph.D. from Ohio State University and specializes in clinical pharmacology for drug delivery systems.
Andrew Einhorn
Chief Financial Officer
CPA with 15+ years in pharmaceutical finance, including executive roles at Edge Therapeutics and Oceana Therapeutics. Holds a B.S. in Finance from American University.
James Schaub
EVP & COO
Operations leader with experience at Trigen Laboratories and King Pharmaceuticals. Holds an M.B.A. from Rutgers Business School and specializes in manufacturing and M&A strategy.
Christopher Klein
General Counsel
Legal executive with prior roles at Fougera Pharmaceuticals and Bristol-Myers Squibb. Holds a J.D. from Fordham University and expertise in pharmaceutical regulatory compliance.
Questions
What does Osmotica Pharmaceuticals specialize in?
We specialize in controlled and modified drug delivery systems through our proprietary Osmodex® technology, offering CDMO services from development to commercial manufacturing.
Where is Osmotica's manufacturing facility located?
Our FDA-inspected facility is located at 895 Sawyer Road, Marietta, Georgia 30062.
What clinical trials are currently active?
We are conducting Phase III trials for arbaclofen ER to treat spasticity in multiple sclerosis patients. Visit clinicaltrials.gov for enrollment details.
What technologies does Osmotica develop?
We focus on laser drilling and Osmotic Technology for extended-release formulations, including approved products like Osmolex ER™ and venlafaxine HCl ER tablets.
