A proven track record of cGMP in sterile drug manufacturing
Hikma’s expertise, talent, and engrained commitment to quality ensure our 503B business meets cGMP (Current Good Manufacturing Practice) standards.
The same Quality that has underpinned the manufacture and distribution of hundreds of millions of vials to US hospitals is the basis of Hikma’s 503B business.
Extensive access to raw
Extensive supplier relationships provide access to both API and finished dosage forms for over 120 drug products.
We are able to leverage the volumes that we manufacture to ensure a consistent supply of all raw materials and components.
Established relationships with our hospital customers
Supported by the same trusted sales and customer service operations that US hospitals rely on.
Additional user-friendly online systems for seamless ordering and tracking of 503B products.
Dedicated, purpose-built facility designed to meet FDA requirements, adding automation and segregation technology.
Every batch is tested for sterility, potency and endotoxins.
What Hikma 503B Represents.
Hikma 503B is a new FDA-Registered 503B Outsourcing Facility focused on providing high quality, ready-to-administer injectable medications that are customized to the specific needs of patients in the United States. Hikma 503B builds on Hikma’s expertise and position as a leading supplier of injectable medicines to US hospitals with a strong reputation for quality and reliability. Our goal is to provide our US hospital customers a reliable source of high quality compounded sterile preparations to enable them to meet the needs of their providers and patients.