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Lutetium Lu 177 dotatate bulk supplier for pharma manufacturers

Lutetium Lu 177 Dotatate 7.4 GBq/ vial Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 7.4 GBq/ vial

Reference Brands: Lutathera (USA, EU)

Category: Oncology Cancer Care

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.

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Product Description:

Lutetium Lu 177 dotatate is a radiopharmaceutical rather than a drug in the ordinary sense. A somatostatin analogue peptide is chemically tethered to a radioactive lutetium-177 atom. The peptide binds somatostatin receptor type 2, which neuroendocrine tumours express in great abundance, and the radionuclide is carried inside the cell where its beta emissions destroy DNA over a range of about two millimetres — long enough to kill neighbouring tumour cells, short enough to spare surrounding tissue.

It is used for somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours, given as four intravenous infusions eight weeks apart, with an amino acid solution co-infused to protect the kidneys from peptide reabsorption. Eligibility is established by receptor imaging beforehand — a tumour that does not take up the tracer will not take up the therapy. Nausea from the amino acid infusion, myelosuppression, and a small long-term risk of myelodysplastic syndrome are the main concerns.

Sourcing notes. This product decays. The half-life is under seven days, so it is manufactured to order against a named patient and a booked infusion slot, shipped in shielded containers under nuclear transport rules, and wasted entirely if the appointment slips. Only licensed nuclear medicine centres can receive it.

How Lutetium Lu 177 Dotatate is supplied today, and licensing ahead of patent expiry

Named-patient import Where a patient needs the product in a market where it is not registered, named-patient import is the lawful route. It requires the treating physician's documentation and authorisation from the destination regulator. We handle this pathway. Named-patient access
Authorised distribution For registered markets, supply runs through the manufacturer's authorised distribution channel. We can identify the authorised route for your market and tell you whether the product is registered there at all. Innovator sourcing
A genericised alternative Where the clinical requirement is the drug class rather than this specific molecule, there is often an off-patent alternative that is faster to register and materially cheaper. Tell us the indication and target market and we will say plainly whether one exists. Discuss alternatives
Licensing and generic development Patents expire country by country, and in many countries development and dossier filing can start before expiry under research and regulatory-review exemptions. We connect manufacturers developing this molecule, dossier holders, licensees and tech-transfer partners for markets where it is, or will become, off-patent. Partner on this molecule
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Frequently Asked Questions

Lutetium Lu 177 dotatate is used to treat somatostatin receptor‑positive gastroenteropancreatic neuroendocrine tumors (GEP‑NETs) in adults and in children aged 12 years and older.

It is a radioconjugate composed of a somatostatin‑analog peptide (Tyr³‑octreotate, DOTA‑TATE) chelated to the radioisotope lutetium‑177.

The trade name is Lutathera.

It is manufactured by Advanced Accelerator Applications, a subsidiary of Novartis.

The generic name is Lutetium Lu 177 dotatate.

The brand name is Lutathera.

It is produced under Good Manufacturing Practice (GMP) by Advanced Accelerator Applications / Novartis, with facilities and supply chain managed internationally.

Lutathera (Lutetium Lu 177 Dotatate) is developed and sold by Novartis (Advanced Accelerator Applications). PharmaTradz handles enquiries for authorised supply of the originator product and for named-patient import where it is not registered.

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