Founded in 2016 and headquartered in New Jersey, USA, Specialty PharmaSource is a trusted global partner for sourcing Comparator Drug Products and Reference Listed Drugs (RLDs) supporting bioequivalence studies and clinical trials worldwide.
Our Specialties:
- Sourcing branded Comparator Drug Products and RLDs, including hard-to-find, shortage-listed, and limited-availability products, in single or multiple batches
- Procurement of unlicensed medicines in accordance with applicable regulatory frameworks
- Clinical trial ancillaries and support supplies
- Clinical packaging, labeling, and controlled storage solutions
- Clinical manufacturing of sterile injectables (vials, prefilled syringes, cartridges, and IV bags)
- Global distribution to healthcare organizations, hospitals, pharmaceutical companies, CROs, and R&D institutions
Our Differentiators:
- Fully compliant with FDA, DEA, DSCSA, GDP, and GCP regulatory requirements
- Demonstrated expertise supporting Phase III oncology and complex clinical trials
- Broad access to branded innovator and generic pharmaceutical products
- Established global import and export infrastructure with regulatory oversight
- End-to-end batch traceability with comprehensive documentation controls
- Proactive and structured supply continuity strategies during drug shortages
At Specialty PharmaSource, we combine U.S.-based regulatory expertise with global reach to deliver reliable, compliant, and secure pharmaceutical sourcing and clinical manufacturing solutions.