Specialized to manufacture oral solid dosage forms, Alcami’s Wilmington, North Carolina site supports preclinical production through commercial launch and supply. Our cGMP manufacturing technologies are arranged in flexible suites to support advanced and complex projects.
Due to counterfeiting, adulteration, theft, and diversion, governments and regulatory agencies have developed regulations to enhance patient safety and supply chain security. On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) made effective several additional requirements that impact labeling and data management for commercially distributed prescription human drug product in the United States.
Investigational New Drug (IND) Filings
ft² across US & EU facilities
US & EU regulatory filings
PharmSci 360 - November 4 - 6
CPhI Worldwide - November 5 - 7
Pharma Integrates - November 18 - 19