4620 Creekstone Drive
Durham, NC 27703
Toll Free: (800) 575-4224
Alcami is a world-class, fully-integrated contract development and manufacturing organization (CDMO) headquartered in North Carolina, with executive offices in Durham and Wilmington. Alcami helps biologics and pharmaceutical companies of all sizes navigate the complex road of delivering breakthrough therapies to patients faster, from concept to commercialization. Alcami connects its global clients with customizable and innovative solutions for API development and manufacturing, solid state chemistry, formulation development, analytical development and testing services, clinical and commercial finished dosage form manufacturing (oral solid dose and parenteral), packaging, and stability services. The company offers an exceptional end-to-end outsourcing opportunity as well as individualized development and manufacturing services that can be combined for a less fragmented, faster product pathway. From early-stage development and scale up to integrated manufacturing and commercial success, Alcami’s expertise ensures the best possible outcome for your product at every level.
Alcami makes it easy to advance a client’s product through the clinic to commercialization. Using an approach that integrates program, project, and process in a unique and highly effective way, Alcami transforms a product’s potential into reality. The company meets all applicable local, state, and federal regulatory requirements, including current GMPs and country guidelines for the US, Canada, EU, and EU Member State regulatory bodies (e.g., EMA, MPA, IMB). The company’s quality management system incorporates international standards and meets expectations established by USP, EP, and JP. The organization complies with all regulations and standards regarding controlled substances (DEA), radioactive materials (NRC), environmental protection (EPA), child-resistant container-closures (CPSC), and employee safety (OSHA).
Alcami’s Durham and Wilmington, North Carolina laboratories offer pharmaceutical development services for small and large molecules in any phase. Since 1985, these facilities have supported more than 500 IND filings and over 50 NDAs, ANDAs, and NADAs. The company’s Germantown, Wisconsin cGMP center of excellence for API development, scale up, and commercialization provides process development and scale up and clinical and commercial supply services for customers worldwide. Its St. Louis, Missouri center of excellence for analytical testing and Wilmington, North Carolina technology center provide comprehensive analytical testing solutions for clients’ new drug entities and biopharmaceuticals as well as generic drugs, chemicals, and animal health and medicated consumer health products. Alcami’s cGMP drug product manufacturing facilities support preclinical, clinical, and commercial supply. Its Charleston, South Carolina, facility focuses on processing parenteral products, while its Wilmington, North Carolina facility manufactures oral solid dosage forms. Both manufacturing sites are fully integrated with the company’s packaging and distribution center. Alcami also has international sales offices in Cambridge, Massachusetts, San Diego, California, and Tokyo, Japan to help support clients across the globe.
Posted Date: 11/25/2019
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