Alcami is a world-class contract development and manufacturing organization (CDMO) headquartered in Wilmington, North Carolina. Alcami is the first company to offer a solution that is tailored to small and mid-size pharmaceutical and biotechnology companies, offering a range of services from four distinct pillars. Beyond that, we can integrate our services so customers experience a simplified engagement with a single project management relationship, full visibility from development into manufacturing, and shorter turnaround times. With over 1,000 employees operating at seven sites in the United States and Europe, 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 a world class end-to-end outsourcing opportunity that can be integrated for a less fragmented, cost-effective, and faster pathway for products through the clinical toward commercialization, as well as individualized development and manufacturing services.
It is our goal to be the most efficient, safe and reliable option to bring your product to market.
We make it easy for our partners to bring their products through the clinic to commercialization, embracing an approach that integrates our operations in a unique and highly effective way and where a product’s potential is turned into reality day-after-day. With a flexible and responsive approach, our Project and Program Management group will ensure the focus is always on the best possible outcome for your product at every level.
Alcami meets all applicable local, state and federal regulatory requirements, including current GMPs and country guidelines for the U.S., Canada, EU and EU Member State regulatory bodies (e.g., 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 drug product development for small and large molecules through two laboratories located in Durham and Wilmington, North Carolina. 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, Wisconsin and Weert, Netherlands support Alcami’s process development / scale-up and clinical and commercial supply of APIs for customers worldwide. The Weert facility also serves as the company’s Center of Excellence for Solid State Chemistry. Regional cGMP analytical laboratories in St. Louis, Missouri, Wilmington, North Carolina and Edison, New Jersey provide comprehensive analytical testing solutions for Alcami customers’ 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 clinical and commercial supply. Our Charleston, South Carolina facility is focused on processing parenteral products while the Wilmington, North Carolina facility is dedicated to solid oral dose manufacture. Both are fully integrated with Alcami’s packaging and distribution center.