4620 Creekstone Drive
Durham, NC 27703
Toll Free: (800) 575-4224
Alcami is a world-class contract development and manufacturing organization (CDMO) headquartered in North Carolina, with executive offices in Durham and Wilmington. With over 1,000 employees operating at nine global locations, our combined capabilities include 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. Alcami offers an exceptional end-to-end outsourcing opportunity as well as individualized development and manufacturing services that can be integrated for a less fragmented and faster pathway for your products. From early-stage development and scale up to integrated manufacturing and commercial success, our expertise ensures the best possible outcome for your product at every level.
Alcami makes it easy for our partners to bring their products through the clinic to commercialization. We embrace an approach that integrates program, project, and process in a unique and highly effective way and where a product’s potential is turned into reality day-after-day. We meet 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 (eg, EMA, MPA, IMB). We also incorporate international standards as part of the Quality Management System and meet expectations established by the USP, EP, and JP. We comply with all regulations and standards, including those regarding controlled substances (DEA), radioactive materials (NRC), environmental protection (EPA), child-resistant container-closures (CPSC), and employee safety (OSHA).
Alcami offers all phases of pharmaceutical development for small and large molecules through two laboratories located in Durham and Wilmington, NC. These facilities have supported more than 500 Investigational New Drug (IND) filings and over 50 NDAs, ANDAs, and NADAs since 1985. Two cGMP API facilities in Germantown, WI, and Weert, Netherlands, support Alcami’s process development/scale-up and clinical and commercial supply for customers worldwide. The Germantown facility is Alcami’s Center of Excellence for API development and manufacturing site. The Weert facility serves as the company’s Center of Excellence for Solid State Chemistry. Regional cGMP analytical laboratories in St. Louis, MI, Wilmington, NC, and Edison, NJ, provide comprehensive analytical testing solutions for Alcami customer’s 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. Our Charleston, SC, facility is focused on processing parenteral products while the Wilmington, NC, facility provides solid oral dose manufacture. Both manufacturing sites are fully integrated with Alcami’s packaging and distribution center. Alcami also recently established international sales offices in Toyko, Japan, and San Diego, California. The Japanese branch provides a home base for Alcami’s local customers and serves Japanese companies interested in developing and manufacturing products for launch in the U.S. market.
Posted Date: 7/3/2018
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