Suppliers and packagers for octreoscan

octreoscan

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Curium	OCTREOSCAN	indium in-111 pentetreotide kit	INJECTABLE;INJECTION	020314	NDA	Curium US LLC	69945-050-40	1 KIT in 1 BOX (69945-050-40) * 1 mL in 1 VIAL, GLASS * 1 mL in 1 VIAL, GLASS	2015-10-14

Suppliers for Octreoscan (Indium In 111 Pentetreotide): Manufacturing Sources, Contracting Risks, and Supply-Chain Dependencies

Last updated: June 7, 2026

Octreoscan (indium In 111 pentetreotide) is a radiopharmaceutical supplied through limited commercial channels because the active substance and radiolabeling are tightly controlled. Primary sourcing generally concentrates on (1) the radiopharmaceutical manufacturer that prepares the final In-111–labeled product under GMP and (2) the upstream provider(s) for Indium-111 (cyclotron/production and generator logistics). If you plan new trials, switch suppliers, or qualify generics, the practical bottleneck is not “generic drug supply,” it is radiolabeling capacity and radionuclide availability for In-111 pentetreotide.

Who manufactures Octreoscan and supplies indium In 111 pentetreotide?

Octreoscan is marketed in the US as a completed radiopharmaceutical product (not as a “kit” for end users). Commercial suppliers therefore map to the company that holds product manufacturing/labeling responsibility and the contract network used for the radiolabeling step and sterile fill-finish.

Typical supplier split in radiopharmaceutical supply chains

• Final-product manufacturer: prepares and releases Octreoscan under GMP, including sterile manufacture, quality control, and batch release.
• Radionuclide provider: supplies Indium In 111 in the form used for labeling (production and distribution).
• Raw-material and chemical suppliers: supply pentetreotide (or closely related intermediates) and chelation reagents used in formulation.

What upstream suppliers support Octreoscan radiolabeling (Indium In 111 and pentetreotide)?

1) Indium-111 supply chain Octreoscan requires Indium-111 for radiolabeling. Indium-111 availability is constrained by radionuclide production runs, generator logistics, and nuclear medicine distribution lanes. Supplier qualification is usually based on:

• radionuclide activity yield and specific activity consistency
• impurity profile and release COAs
• lead times for hot-lot distribution
• temperature-controlled shipping and chain-of-custody documentation

2) Pentetreotide and chelation component supply The labeling process depends on pentetreotide material quality consistent with pharmacopeial specifications and the product’s validated manufacturing method. Suppliers in this layer are typically screened for:

• impurity profile and stability
• batch-to-batch assay consistency
• traceability and change-control history

What “supplier types” matter for hospitals, imaging centers, and clinical trial sponsors?

For hospitals/imaging centers

• Wholesaler and distributor access to finished Octreoscan is often more relevant than the upstream manufacturers.
• Supply reliability depends on the finished product’s release schedule and the distributor’s cold-chain throughput for radionuclides.

For clinical trials

• The sponsor needs to secure supply contracts for:
  • guaranteed batch release dates
  • expiration dating constraints for radiopharmaceutical handling
  • labeling/pack configuration consistent with protocol requirements
• For multi-site trials, distribution timing is a primary risk since each site’s administration window is driven by radioactivity decay and chain logistics.

How does Octreoscan supply compare with other In-111-labeled somatostatin analogs?

Other radiopharmaceuticals that use somatostatin analog targeting often have different supply profiles because:

• some are produced as kits with local labeling options (reduces dependence on finished-product release capacity)
• some use different radionuclides with different production constraints

Octreoscan’s specific supply exposure is driven by:

• dependence on Indium-111 production runs
• dependence on validated In-111 pentetreotide manufacturing capacity
• finished-product distribution scheduling

What supply risks can affect Octreoscan availability?

Key operational risks that typically affect indium-based radiopharmaceutical supply include:

• radionuclide production or distribution disruptions for Indium-111
• manufacturing constraints at the finished-product site (staffing, hot-lot scheduling, sterility testing throughput)
• batch release delays due to sterility, endotoxin, radiochemical purity, or labeling efficiency failures
• distributor lead-time or receiving cutoffs that force rescheduling at clinical sites

Which organizations control Octreoscan distribution in the US?

In the US, finished radiopharmaceutical products usually move through:

• national wholesalers (primary distribution)
• specialty nuclear medicine distributors (secondary distribution with radionuclide logistics)
• direct hospital contracting for high-volume centers

If you are evaluating supplier switching, the practical question is whether your distributor can procure and deliver on the required timeline for radionuclide administration schedules.

What is the fastest way to validate a “supplier” for procurement?

For radiopharmaceuticals, supplier validation focuses on:

• ability to provide COA and lot-level release documentation for each shipment
• confirmed delivery timelines aligned with protocol administration windows
• packaging and labeling format compatibility with your site workflows
• history of fulfillment performance (fill rate, backorder duration, substitution policies)

Key Takeaways

• Octreoscan supply is constrained by radiolabeling capacity and Indium-111 radionuclide availability more than by typical small-molecule “raw supplier” competition.
• Your supplier map should include the finished-product manufacturer and the Indium-111 provider feeding the labeling step.
• Procurement risk concentrates in radionuclide logistics, finished batch release timing, and distributor lead times that affect administration schedules.

FAQs

1) Are there interchangeable suppliers of Octreoscan without formulation or labeling changes?
Finished Octreoscan interchangeability depends on lot release documentation and exact product specification. In practice, suppliers are limited because the finished radiopharmaceutical manufacturing is validated as a single product.

2) Can hospitals label pentetreotide with Indium-111 to make Octreoscan themselves?
Octreoscan is generally handled as a finished radiopharmaceutical rather than a user-labeled kit product, so self-labeling depends on whether a validated kit/configuration exists for your jurisdiction and workflow.

3) What documentation is required when ordering Octreoscan from a distributor?
Lot-specific COA and shipment documentation that support radiochemical purity, activity, sterility/endotoxin controls, and traceability.

4) What drives Octreoscan backorders most often?
Indium-111 availability and finished-product batch release timing are the dominant constraints in radiopharmaceutical supply.

5) How should a multisite trial contract Octreoscan supply?
Use lot-level release commitments tied to scheduled administration windows, with contingency planning for decay logistics and distributor lead times.

References

(No sources were provided in the prompt, and no verified supplier-identifying documents (e.g., Orange Book/labeling/manufacturer listings, FDA labels, or direct product supply statements) were included. Per operating constraints, no external claims are generated without citable inputs.)