Alcami is a contract development and manufacturing organization (CDMO) with executive offices in Wilmington and Durham, North Carolina. Our goal is to support our clients in bringing 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.
Our capabilities include:
- API development and manufacturing
- Analytical development
- Analytical testing
- Formulation development
- High-potency APIs
- Oral solid dose manufacturing
- Packaging and labeling
- Sterile/parenteral manufacturing
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Alcami meets all applicable local, state, and federal regulatory requirements, including current GMPs and country guidelines for the United States, 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).
It is our goal to be the most efficient, safe, and reliable option to bring your product to market.