How to Source Lutetium Lu 177 dotatate for Pharmaceutical Formulation

Lutetium Lu 177 dotatate (Injection, 7.4 GBq/ vial) is classified under Oncology Cancer Care. It is therapeutically aligned with reference brands such as Lutathera (USA, EU). This guide highlights key sourcing factors buyers should consider when procuring high-quality Lutetium Lu 177 dotatate for formulation, R&D, or bulk manufacturing.

Product Overview: Lutathera is a radiolabeled peptide receptor radionuclide therapy (PRRT) used to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs) that express somatostatin receptors. It works by delivering targeted radiation directly to tumor cells, minimizing damage to surrounding healthy tissue. The therapy is administered via intravenous infusion under specialized medical supervision, usually in cycles of four doses spaced eight weeks apart.

1. Regulatory Compliance & Documentation

Ensure suppliers provide:

• ✔ Valid DMF (Drug Master File)
• ✔ COA (Certificate of Analysis) for each batch
• ✔ GMP, ISO, or ICH Q7 compliance certificates

2. Purity, Grade & Specification Matching

Lutetium Lu 177 dotatate must meet exact grade and purity for your dosage form:

• ✔ USP / EP / JP grade verification
• ✔ Particle size distribution check
• ✔ Residual solvent and heavy metal limits

3. Supplier Reliability & Audit History

• ✔ Positive past audit reports
• ✔ Pharma client references
• ✔ Years of proven API manufacturing experience

4. Commercial Terms: Pricing, MOQ & Flexibility

• ✔ Transparent pricing
• ✔ Pilot batch MOQ flexibility
• ✔ Volume-based discounts

5. Lead Time, Inventory & Logistics

Typical lead time for Lutetium Lu 177 dotatate is 4–6 weeks.

• ✔ Emergency dispatch options
• ✔ Regional warehousing
• ✔ Special storage if needed

6. Formulation Support

• ✔ Technical datasheets
• ✔ Sample availability
• ✔ Stability study support

Conclusion

Sourcing Lutetium Lu 177 dotatate is more than procurement—it’s a strategic partnership. With its injection form and 7.4 GBq/ vial specification, choosing a compliant supplier ensures consistent quality and regulatory approval. Prioritize documentation, verify compatibility, and build relationships with transparent, reliable suppliers to secure long-term success.

Frequently Asked Questions For Sourcing of Lutetium Lu 177 dotatate