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.
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.
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.
Successful Application of the New Elemental Impurities Regulation
Balancing HPAPI Control with the Chemistry and Efficiency Needs of a CDMO
Extractables & Leachables 101: The Past, Present, and Future
Important Steps for Quota, Import, and Export Processes for DEA Controlled Substances
Editorial: Aligning with Sponsors for Strategic Growth
White Paper: Optimizing HPAPI Manufacturing Performance
Formulating for Orphan Indication Drug Products
White Paper: A Practical Approach to Extractables and Leachables on Manufacturing Surfaces
Alcami Employee Recognized with Honor Flight
Alcami President & CEO Elected as 1st Vice President of the Board of Directors of the Drug, Chemical & Associated Technologies Association
Alcami Helps Medicines Development for Global Health Secure FDA Approval of Moxidectin for River Blindness
White Paper: Insight into Orphan Drug Formulations and Regulations
Case Study: Stability When You Need it Most
