What is RLD - Reference Listed Drug definition and explanation for pharmaceutical research

Reference Listed Drugs (RLDs) are FDA-approved innovator medicines used as standards in bioequivalence testing for generics and biosimilars. These products play a critical role in:


  • Supporting clinical and bioequivalence (BE) studies
  • Facilitating regulatory filings across multiple markets
  • Ensuring accurate comparisons for generics and formulations
  • Sourcing niche, patented, or difficult-to-access products globally

Ikris Pharma International bridges the access gap by sourcing authentic, batch-certified RLDs from trusted global manufacturers. We ensure full compliance with all relevant regulations and logistics requirements.

Why Global Sponsors Trust Ikris for Comparator Drug Sourcing


  • Well-established Network – We source RLDs from 30+ countries, including the USA, EU (Belgium, Bulgaria, Germany, France, Latvia, Poland, Netherlands, etc), Canada, Japan, Australia, and the UK.
  • Comparator Drug Expertise – Extensive catalog of originator brands and bioequivalence-compliant batches.
  • EU-GDP Certified Warehouse – Fully compliant storage facility operating under EU GDP guidelines with SOPs aligned to European regulatory mandates.
  • Controlled Storage & Delivery – Cold chain, ambient, and temperature-specific supply chain solutions.
  • 100% Regulatory Documentation – We provide all required documents, including COA (Certificate of Analysis), COC (Certificate of Conformity), COO (Certificate of Origin), Packing List, Batch Numbers, Product Traceability, and Country-Specific Invoices.
  • Trusted by CROs & Sponsors – Partnerships with top clinical research organizations and pharma manufacturers.
Four-step seamless RLD procurement process for clinical trials

Broadest Therapeutic Access for Clinical & BE Trials

  • Oncology & Hematology
  • Central Nervous System (CNS)
  • Cardiology & Metabolic Disorders
  • Immunology & Autoimmune Diseases
  • Rare & Orphan Conditions
  • Antiretrovirals & Antivirals
  • Gastroenterology & Hepatology
  • Endocrinology & Hormonal Therapies
  • Respiratory & Allergy Treatments
  • Pain Management & Rheumatology
  • Pediatric & Geriatric Medicines

Logistics & Delivery

  • Temperature-controlled packaging with stability data
  • Real-time GPS-enabled tracking
  • Delivery to CROs, hospitals, research labs, and sponsors in over 40+ countries
  • Import clearance & customs support for major regulatory markets

Documentation & Compliance

  • CoA, MSDS, Batch Traceability & Certificate of Origin
  • Sourced from US FDA, EMA, TGA, MHRA & PMDA-approved markets
  • Follows WHO-GDP and GDP-compliant shipping standards
  • Confidentiality & integrity maintained for sponsor and study data

Who We Work With

  • CROs for comparator drug sourcing in BE and clinical trials
  • Global pharma innovators for originator reference supply
  • Biosimilar & generic developers for regulatory submissions
  • Regulatory teams needing compliant comparator batches
  • Hospitals & research institutes for study-based access

Pharma Compliances

Certified by US FDA for compliance with global pharmaceutical standards
WHO-GMP certified facility ensuring Good Manufacturing Practices
EU-GMP approved for high-quality pharmaceutical manufacturing
Approved by ANVISA Brazil for pharmaceutical exports
EMA compliant for medicines meeting European quality standards
SAHPRA approved pharmaceutical supplier in compliance with South African regulations
PIC/S certified ensuring internationally recognized GMP compliance
TGA approved pharmaceutical exports meeting Australian standards
UK MHRA licensed for safe and regulated medicine supply
PMDA Japan compliant for pharmaceutical quality and safety

Ready to Export Finished Formulations?

Looking for a pharmaceutical exporter who understands regulations, ensures authenticity, and delivers with precision? Connect with Ikris Pharma International today.

Please feel free to contact us:

+91-8527273611 - +32 4286 1216
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