Reference Listed Drugs (RLD) Supplier

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.

• 🌐 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.

1️⃣ Request & Product Identification:
Submit your requirement (INN/brand name, country of origin, pack size, quantity, and study type). Our global sourcing team finds the exact match from verified suppliers.
2️⃣ Quotation & Documentation:
We provide pricing, regulatory status, CoA availability, and shipping details. Special instructions (like stability studies or expiry window) are handled with care.
3️⃣ Regulatory & Customs Clearance:
We handle all CDSCO, DGFT, MOHFW, and international documentation for compliant delivery to your trial site or lab—seamlessly.
4️⃣ Verified Packing & Timely Delivery:
RLDs are dispatched under validated conditions—ambient, cold chain, or ultra-cold—as per study protocols. Global deliveries typically occur within 7–21 working days.

• 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

• 📦 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

• 🧾 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

• ✅ 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