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
Submitting Samples through Alcami OnDemand™
Early Phase Development of Biologics
Regulatory Requirements for Early Phase Drug Product Development
Editorial: Designing a CMC Strategy for Accelerated Development of Biotherapeutics
Editorial: Novel Therapies Roundtable Discussion
Editorial: Overcoming the Opioid Overdose Crisis
White Paper: Structural Characterization of Biologics Using High-Resolution Mass Spectrometry
Alcami Pays Tribute to Fallen Patriots this Memorial Day
Alcami Supports Homestead High School’s Varsity Robotics Club
Alcami and Students 2 Science Inspire Future Scientists
Bio Integrates - May 22BIO International - June 3 - 6Chemspec Europe - June 26-28
