Saxsons Group
Lu-177 No-Carrier-Added + PSMA-617 Theranostic Therapy Vial
n.c.a.
no carrier added
GMP
manufactured
PSMA-617
application
mCRPC
indication
Cold-chain
India delivery

Authorised Indian Distributor

Saxsons Group

New Delhi, India · Since 1997

SX
Nuclear Medicine NM-002 AERB Importable No-Carrier-Added GMP Produced

Lu-177 n.c.a. + PSMA-617 VISION-Protocol Theranostic — PSMA-positive mCRPC

No-carrier-added Lutetium-177 (produced by SHINE Medical, supplied across India by Saxsons) paired with PSMA-617 (vipivotide tetraxetan) for targeted radionuclide therapy in metastatic castration-resistant prostate cancer. The VISION-trial protocol — n.c.a. starting material, ≥99.9 % radionuclidic purity, AERB-importable, delivered cold-chain across India.

Key Features

  • No-carrier-added (n.c.a.) production — highest specific activity available
  • GMP-compliant manufacturing for clinical use
  • Optimal tumour-to-background ratio for PSMA-617 labelling
  • Low mass dose — minimal pharmacological effect at therapeutic activity levels
  • Consistent specific activity batch-to-batch for reproducible dosimetry
View all features

All Features

  • No-carrier-added (n.c.a.) production — highest specific activity available
  • GMP-compliant manufacturing for clinical use
  • Optimal tumour-to-background ratio for PSMA-617 labelling
  • Low mass dose — minimal pharmacological effect at therapeutic activity levels
  • Consistent specific activity batch-to-batch for reproducible dosimetry
  • Full radionuclidic purity testing per pharmacopoeial standards
  • Cold-chain managed delivery from production to Indian hospitals
  • Compatible with PSMA-617 kit labelling at standard radiopharmacy conditions
  • Certificate of Analysis and batch release documentation with every shipment
  • AERB import documentation support through Saxsons Group
  • Activity calibration at a defined date/time — dose ready on delivery
  • Supported by dosimetry consultation for therapy planning

Technical Specifications

Radionuclide Lutetium-177 (Lu-177)
Production route No-carrier-added (n.c.a.) reactor production
Half-life 6.647 days
Decay mode β⁻ (max 498 keV); γ 113 keV (6.4%), 208 keV (11%)
Specific activity n.c.a. — highest available (TBq/mg)
Chemical form Lutetium chloride in dilute HCl
Radionuclidic purity ≥ 99.9% (Ph. Eur. compliant)
Radiochemical purity Tested post-labelling; typical ≥ 98%
Clinical indication PSMA-positive metastatic castration-resistant prostate cancer (mCRPC)
Labelling target PSMA-617 (vipivotide tetraxetan)
Therapy sessions Up to 6 cycles; 7.4 GBq per cycle (standard)
Quality release Certificate of Analysis per batch; GMP documentation
AERB status Import licence required; Saxsons manages regulatory documentation

Applications

Targeted theranostics — one isotope, imaging and therapy

PSMA-617 Therapy (mCRPC)

FDA/EMA-approved treatment backbone for metastatic castration-resistant prostate cancer. Lu-177 PSMA-617 delivers targeted β-radiation to PSMA-expressing tumour cells.

Post-PSMA PET Response

Paired with Ga-68 or F-18 PSMA PET for theranostic cycle planning and inter-cycle response assessment. Same PSMA target — one for imaging, one for therapy.

Dosimetry-Guided Therapy

n.c.a. Lu-177's high specific activity enables individualised dosimetry with SPECT/CT using the 208 keV gamma photon — tumour and organ dose quantification between cycles.

Academic & Research

Consistent n.c.a. batches support comparative dosimetry research, novel PSMA-targeting peptide development and multi-centre theranostic clinical trials.

Combination Protocols

Emerging combination data with PARP inhibitors and AR-targeted agents. n.c.a. purity required for mechanistic studies of radiosensitisation.

Expanded PSMA Indications

Investigational use in PSMA-positive salivary gland carcinoma, renal cell carcinoma and other PSMA-overexpressing solid tumours.

Why Lu-177 n.c.a. + PSMA-617?

n.c.a.
No carrier added

Carrier-added Lu-177 dilutes specific activity, lowering PSMA-617 labelling efficiency and increasing non-specific radiation dose. n.c.a. Lu-177 achieves the highest labelling yields and lowest cold-metal content — the clinical standard for PSMA therapy.

GMP
Clinical compliance

GMP certification covers the full production chain — target irradiation, chemical separation, formulation, QC and release. Every shipment carries batch release documentation for AERB compliance and hospital pharmacy acceptance.

India reach
Logistics managed

Saxsons coordinates cold-chain import, AERB licensing, customs clearance and same-day hospital delivery on therapy day. Your radiopharmacist receives ready-to-label Lu-177 — no logistics burden on the department.

Catalogs & Resources

SHINE product page for the upstream Lu-177 n.c.a. starting material. Contact Saxsons for AERB import documentation, cold-chain scheduling and PSMA-617 peptide kit pairing.

Available through Saxsons Group

Establish your PSMA theranostics programme

Contact Saxsons Group for supply agreements, AERB import documentation and dosimetry support for your Lu-177 + PSMA-617 therapy programme in India.