Tablets & Capsules

TC0614SB

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Xcelience offers a suite of services from preformulation and development through manufacturing and clinical distribution. Entrust all your clinical outsourcing needs by partnering with a single CDMO. Services include preformulation development, analytical services, formulation development, GMP manufacturing, and clinical supplies packaging and distribution. Xcelience's responsibility is delivering the best science and service with our commitment to quality, cost and speed. Since 1997, Xcelience has been known for reliably expediting drug product development and clinical manufacturing for oral solid, semi-solid and liquid dosage forms. In 2012, Xcelience increased its existing service offerings capacity for packaging and distribution, by opening the West Grace Street facility in Tampa. In 2013, Xcelience introduced its first international expansion by opening a new facility in Birmingham, UK. This facility provides a central distribution hub for labeling and distribution throughout Europe and is the first step in a multi-stage plan to provide our clients with global clinical packaging and distribution services. GMP Manufacturing Clinical supplies manufacturing capabilities include: • Tablets • Capsules • API into capsule • Liquid in capsule • Powder in bottle • Semi-solids • Non-sterile liquids Clinical Supplies Packaging, Distribution & Logistics • Primary and secondary packaging • Global distribution • Storage • Returns, retains, reconciliation and destruction • Clinical supplies project management Xcelience 35415 West Laurel St. Tampa, FL 33607 Tel: 813-286-0404 Email: info@xcelience.com Website: www.xcelience.com Company Description and Background Preformulation • Salt screens • Polymorph screens • Drug substance characterization • Excipient compatibility • Accelerated stability • Chiral stability Analytical Services • Method development • Qualification and validation • Raw material testing • Stability sample analysis • Dissolution testing • Chiral determination • Cleaning evaluations • Technical packages for drug substance Formulation Development • Tablets (immediate, modified & sustained release, chewable & lozenges) • Liquid or powder filled capsules (gelatin or HPMC) • Semi-solids (ointments, creams & gels) • Oral liquids (solutions, suspensions & emulsions) Services and Capabilities Xcelience 104 June 2014 Tablets & Capsules Solid Dosage SourceBook Sourcebook_PBE-CCR 6/10/14 1:37 PM Page 104

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