Authorised Indian Distributor
Saxsons Group
New Delhi, India · Since 1997
Lu-177 n.c.a.No-Carrier-Added Lutetium-177 — Theranostic Building Block
The starting material for every Lu-177 theranostic protocol — produced by SHINE Medical in Janesville, Wisconsin and supplied across India by Saxsons. No-carrier-added ¹⁷⁷LuCl₃ in 0.04 M HCl, ≥99.9 % radionuclidic purity, ≥3,000 GBq/mg specific activity at calibration. The chemistry inputs that decide PSMA-617, DOTATATE and FAPI labelling yields. Cold-chain delivered across India with AERB import documentation.
Key Features
- No-carrier-added (n.c.a.) production — no stable Lu-176 / Lu-175 carrier in the matrix, the highest specific activity reachable in clinical supply
- Specific activity ≥3,000 GBq/mg at calibration, with batches reaching ≈3,700 GBq/mg — the same Lu-177 mass carries far more radioactive atoms, so the labelling kit competes against fewer cold lutetium ions
- Radionuclidic purity ≥99.9 % ¹⁷⁷Lu at calibration (Ph. Eur. compliant)
- Lu-177m metastable contamination held to negligible levels — the long-lived 160-day isomer that drives carrier-added waste decisions is essentially absent, so spent-vial waste decays on the ~6.65-day primary half-life
- Standard chemical form: ¹⁷⁷LuCl₃ in 0.04 M HCl — drop-in compatible with PSMA-617, DOTATATE, FAPI-46 and DOTA-conjugate radiolabelling SOPs
All Features
- No-carrier-added (n.c.a.) production — no stable Lu-176 / Lu-175 carrier in the matrix, the highest specific activity reachable in clinical supply
- Specific activity ≥3,000 GBq/mg at calibration, with batches reaching ≈3,700 GBq/mg — the same Lu-177 mass carries far more radioactive atoms, so the labelling kit competes against fewer cold lutetium ions
- Radionuclidic purity ≥99.9 % ¹⁷⁷Lu at calibration (Ph. Eur. compliant)
- Lu-177m metastable contamination held to negligible levels — the long-lived 160-day isomer that drives carrier-added waste decisions is essentially absent, so spent-vial waste decays on the ~6.65-day primary half-life
- Standard chemical form: ¹⁷⁷LuCl₃ in 0.04 M HCl — drop-in compatible with PSMA-617, DOTATATE, FAPI-46 and DOTA-conjugate radiolabelling SOPs
- Standard activity concentration 1.0 Ci/mL (37 GBq/mL) at calibration
- Produced by SHINE Medical (Janesville, Wisconsin) under cGMP and ICH-Q7; supported by an FDA Drug Master File
- Cold-chain delivery from production to Indian hospital pharmacy — calibration to a defined date/time so the dose lands ready for labelling on therapy day
- AERB sealed / unsealed source import documentation handled by Saxsons
- Certificate of Analysis, radionuclidic purity report and batch release documentation with every shipment
- Compatible with ¹⁷⁷Lu-DOTATATE PRRT, ¹⁷⁷Lu-PSMA-617 prostate theranostics and ¹⁷⁷Lu-FAPI emerging-tumour-stroma protocols — the same starting material across all three
- Dosimetry consultation available for cycle planning (208 keV imaging gamma for post-therapy SPECT/CT)
Technical Specifications
| Radionuclide | Lutetium-177 (¹⁷⁷Lu) |
| Production route | No-carrier-added (n.c.a.) — no stable Lu carrier in the matrix |
| Half-life | 6.647 days |
| Decay mode | β⁻ (Eβ,max 498 keV; mean 134 keV) + γ 113 keV (6.4 %), 208 keV (11 %) |
| Specific activity | ≥3,000 GBq/mg at calibration; batch peaks ≈3,700 GBq/mg |
| Activity concentration | 1.0 Ci/mL (37 GBq/mL) at standard calibration time |
| Chemical form | n.c.a. ¹⁷⁷LuCl₃ in 0.04 M HCl solution |
| Radionuclidic purity | ≥99.9 % ¹⁷⁷Lu (Ph. Eur. compliant) |
| Radiochemical purity | ≥99 % as ¹⁷⁷LuCl₃ |
| Lu-177m contamination | Negligible — long-lived (≈160 d) isomer effectively absent; waste decays on ≈6.65 d half-life |
| Manufacturer | SHINE Medical Technologies (Janesville, Wisconsin, USA) |
| Regulatory framework | cGMP, ICH-Q7, FDA-21CFR; supported by SHINE FDA Drug Master File |
| Labelling compatibility | PSMA-617 · DOTATATE · FAPI-46 · DOTA-conjugate peptides |
| AERB status | Import licence required; Saxsons manages regulatory documentation |
Applications
One n.c.a. Lu-177 supply chain — DOTATATE, PSMA, FAPI and beyond
¹⁷⁷Lu-DOTATATE PRRT
Peptide receptor radionuclide therapy in somatostatin-receptor-positive gastroenteropancreatic and bronchopulmonary NETs. n.c.a. purity maximises peptide labelling yield and minimises cold-DOTATATE competition for SSTR2 binding sites.
¹⁷⁷Lu-PSMA-617 mCRPC therapy
Targeted β-radiation to PSMA-expressing prostate cancer cells in metastatic castration-resistant disease. n.c.a. delivers the high specific activity required for dosimetry-guided multi-cycle planning.
¹⁷⁷Lu-FAPI tumour-stroma
Emerging fibroblast-activation-protein-targeted therapy across pancreatic, sarcoma, breast and other FAP-positive tumours. n.c.a. Lu-177 is the regulatory-compliant starting material for clinical and academic FAPI protocols.
Theranostic pairing with Ga-68 PET
Same molecular target on the diagnostic and therapeutic side — Ga-68 DOTATATE / PSMA / FAPI on PET, ¹⁷⁷Lu on therapy. n.c.a. Lu-177 keeps the imaging-therapy chain consistent on specific activity.
Post-therapy SPECT/CT dosimetry
The 208 keV gamma emission enables quantitative SPECT/CT imaging after each Lu-177 cycle. n.c.a. activity per peptide lets the dosimetrist resolve tumour and organ uptake at clinical activity levels.
Investigator-initiated trials
Academic theranostic programmes in India (AIIMS, Tata Memorial, BARC-collaborating centres) use n.c.a. Lu-177 for novel-peptide protocols. Saxsons supports IND-equivalent documentation and audit trail.
Why Lu-177 n.c.a.?
A labelling kit competes for binding sites against any cold lutetium in the matrix. Carrier-added Lu-177 typically lands at ~600 GBq/mg; n.c.a. at ≥3,000 GBq/mg means roughly 5× fewer cold-Lu atoms per labelled molecule. That difference shows up directly as higher labelling yield, lower DOTATATE / PSMA-617 / FAPI dose, and a cleaner tumour-to-background ratio at imaging.
Carrier-added Lu-177 carries a Lu-177m (metastable, T½ ≈160 d) impurity. That contaminant drives long-tail kidney dose during therapy and a long decay-store dwell time for vials and patient excreta. n.c.a. production effectively eliminates Lu-177m, so the spent-vial waste decays on the primary 6.65-day half-life — practical decay-store rotation, lower cumulative organ dose.
SHINE Medical produces the starting material under cGMP and ICH-Q7, with an FDA Drug Master File on file. For an Indian centre running DOTATATE, PSMA or FAPI under AERB licensing or hospital ethics-committee oversight, the upstream regulatory dossier is already assembled — Saxsons supplies the import-side licensing paperwork from there.
Catalogs & Resources
SHINE product page. Contact Saxsons for AERB import documentation, calibration date scheduling and India pricing.
Lu-177 n.c.a.
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For Nuclear-Medicine Physician
One Lu-177 supply, three theranostic clinics
DOTATATE for NETs, PSMA-617 for prostate, FAPI for tumour-stroma — three indications sharing one n.c.a. supply chain. What shares upstream, what doesn't share downstream, and three traps that catch first-time programmes.
Read thisNuclear-Medicine PhysicianWhy the specs define n.c.a.
Specific activity ≥ 3,000 GBq/mg, radionuclidic purity ≥ 99.9 %, radiochemical purity ≥ 99 % — the three numbers that separate genuine n.c.a. from carrier-added Lu-177 marketed as n.c.a., and what changes in the patient when any one is missed.
Read thisFAQ
Lu-177 n.c.a. supply — questions we hear from Indian theranostic teams
What n.c.a. actually means at the chemistry bench, why specific activity governs tumour dose delivery, which theranostic protocols use n.c.a. Lu-177, and how the activity is scheduled against the therapy list.
Q.What is the difference between "carrier-added" (c.a.) and "no-carrier-added" (n.c.a.) Lu-177?
Carrier-added Lu-177 is produced by direct neutron activation of natural Lu-176 in a reactor — the product contains a large amount of unactivated Lu (the "carrier") that competes with the Lu-177 for binding to the targeting molecule. No-carrier-added Lu-177 is produced by neutron activation of enriched Yb-176 followed by chemical separation from the ytterbium — the product is essentially pure Lu-177 with negligible carrier lutetium. Specific activity of n.c.a. Lu-177 is 2–3 orders of magnitude higher than c.a.
Q.Why does higher specific activity matter for theranostic labelling?
The clinically-relevant PSMA / DOTATATE / FAPI targeting molecules bind Lu ions one-to-one at the DOTA chelator. With carrier-added Lu-177, most of the DOTA sites end up bound to unactivated Lu — effectively "cold" DOTATATE that competes with the therapeutic Lu-177-DOTATATE for the tumour receptor. n.c.a. Lu-177 delivers a therapeutic mass of the labelled molecule at the tumour without receptor saturation by cold competitor — the tumour dose per administered activity is higher, and the ligand mass administered to the patient is smaller.
Q.Which theranostic protocols is n.c.a. Lu-177 used for in India?
Lu-177-PSMA-617 for metastatic castration-resistant prostate cancer (mCRPC), Lu-177-DOTATATE for gastroenteropancreatic and lung neuroendocrine tumours (NETs), Lu-177-FAPI for FAP-expressing solid tumours in centres running clinical protocols, and investigational Lu-177-labelled antibody / peptide constructs. Every one of these protocols specifies n.c.a. quality Lu-177 in the labelling procedure — c.a. Lu-177 is not clinically appropriate.
Q.How can our hospital verify that a Lu-177 shipment is genuinely no-carrier-added and not carrier-added product being sold under an n.c.a. label?
Not every Lu-177 sold on the Indian market as "n.c.a." actually meets the n.c.a. specification. Some batches supplied under the n.c.a. label are in fact carrier-added product — the vials look the same and the printed label is not proof. The Certificate of Analysis is the only defensible check, and three fields on the CoA distinguish the grades. (1) Specific activity — genuine n.c.a. Lu-177 typically reports at least 500 GBq/mg at reference date, with reputable suppliers routinely specifying above 3 000 GBq/mg; carrier-added Lu-177 typically reports around 15–40 GBq/mg, an order of magnitude or more below the n.c.a. floor. (2) Production route — n.c.a. is produced by chemical separation from an enriched Yb-176 target; c.a. is produced by direct neutron activation of a Lu-176 target. The CoA states the route. (3) Lu-177m content (the 160-day metastable contaminant) — genuine n.c.a. has controlled and low Lu-177m; c.a. routes carry more. Verify all three fields on the per-lot CoA before releasing the batch to the labelling chemistry. If the specific-activity number falls well below 500 GBq/mg despite the label saying "n.c.a.", the material is not what the label claims.
Q.What is the Saxsons position on Lu-177 grade traceability?
The Lu-177 supplied through Saxsons Group is no-carrier-added — every consignment ships with a Certificate of Analysis from the production facility documenting the specific activity, production method and Lu-177m content, plus receiving documentation for the AERB dossier. If the labelling radiopharmacy or nuclear-medicine department wants the CoA before the shipment leaves for the site, Saxsons supplies it — the CoA is a standard document, not privileged information, and every reputable supplier is willing to share it pre-shipment.
Q.How is Lu-177 delivered against a specific patient administration date?
Lu-177 has a 6.65-day half-life. The activity is scheduled from the production reactor / separation facility so it lands in the hospital hot lab with enough headroom to still deliver the prescribed activity on the treatment morning after labelling and QC. Saxsons coordinates the weekly production window against the department's scheduled Lu-177 therapy list.
Q.How is Lu-177 supplied and licensed in India?
Distributed across India by Saxsons Group. Supply covers scheduled-date delivery, cold-chain logistics, receiving documentation for AERB, per-consignment activity certification, and clinical-support coordination with the labelling radiopharmacy and the theranostic clinic. AERB sealed / unsealed source import registration handled by Saxsons.
Lu-177 n.c.a. supplier in India — Saxsons Group
Saxsons Group has supplied nuclear medicine equipment to over 1,000 Indian hospitals since 1988. Every consignment of Lu-177 n.c.a. ships with cold-chain logistics, AERB import documentation, CDSCO registration references and a Certificate of Analysis delivered before dispatch — the paperwork your radiation-safety and procurement teams need, pre-assembled.
- Nationwide delivery footprint — every metro and tier-2 city in India, scheduled to your treatment / procedure calendar.
- AERB & CDSCO documentation — import licence, radiation-safety paperwork and RSO briefing pre-assembled for the audit file.
- 40+ years in Indian oncology — long-standing supply relationships with AIIMS, Tata Memorial, and hundreds of tertiary-care centres.
- Single point of accountability — one purchase order, one delivery contact, one after-sales team across the whole product family.
Also supplied by Saxsons Group across India
Build your Lu-177 theranostic supply chain on n.c.a. starting material
Contact Saxsons Group for n.c.a. Lu-177 supply agreements, AERB import documentation and cold-chain scheduling across India — for DOTATATE, PSMA-617 and FAPI programmes alike.