Authorised Indian Distributor
Saxsons Group
New Delhi, India · Since 1997
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.
| 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 |
One n.c.a. Lu-177 supply chain — DOTATATE, PSMA, FAPI and beyond
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.
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.
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.
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.
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.
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.
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.
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
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 this Nuclear-Medicine PhysicianSpecific 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 thisContact 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.