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.
Whether you are looking for an all-inclusive integrated offering or an individualized development or manufacturing service, Alcami has the solution to the complex needs of your product.
The increasing trend of highly potent active pharmaceutical ingredients (HPAPIs) being used in new drug development candidates has created a tremendous demand for high containment development and production capabilities.
Balancing HPAPI Control with the Chemistry and Efficiency Needs of a CDMO
Extractables & Leachables 101: The Past, Present, and Future
The Importance of Microbial In-Use Studies
Early Phase Development of Biologics
eBook: Analytical Testing in Drug Development
Analytics in Solid State Chemistry: What You Need to Know
A 3-Minute Introduction To Rapid Sterility Testing
Introduction to Quality by Design
Editorial: Enabling Technologies Advance Poorly Soluble Highly Potent APIs
500Investigational New Drug (IND) Filings
500,000ft² across US & EU facilities
600 US & EU regulatory filings
Alcami and Wisconsin Department of Natural Resources Enter Third Year of Environmental Stewardship Program
Video: High-Potency APIs
Video: Animal Health
ChemOutsourcing - September 17 - 19
Contract Pharma - September 26 - 27
BioJapan - October 9 - 11
BioFlorida - October 20 - 22
PDA Micro - October 21 - 23
