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 US.
Alcami's new customer portal allows you unprecedented and rapid access and visualization into your ongoing projects. Now you can request a quote, submit your samples and check the test status of your materials online and on your mobile device.
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 (HPAPI) being used in new drug development candidates has created a tremendous demand for high containment development and production capabilities.
Quoting and Sample Submission. Made Simple.
Successful Application of the New Elemental Impurities Regulation
Balancing HPAPI Control with the Chemistry and Efficiency Needs of a CDMO
White Paper: Optimizing HPAPI Manufacturing Performance
Formulating for Orphan Indication Drug Products
White Paper: A Practical Approach to Extractables and Leachables on Manufacturing Surfaces
Successful Methods for Obtaining Orphan Drug Approval
Considerations for Abuse-Deterrent Category One Syringeability Studies
Alcami and UNCW Awarded Biomanufacturing Workforce Development Grant
Alcami Renews Partnership with Wisconsin Department of Natural Resources to Revitalize State Trails
Alcami Announces Donation to Wilmington, North Carolina Fire Department
eBook: Guide to Stability
