Suppliers and packagers for generic pharmaceutical drug: indium in-111 pentetreotide kit

indium in-111 pentetreotide kit

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 and packagers for generic pharmaceutical drug: indium in-111 pentetreotide kit

Last updated: May 30, 2026

Who supplies the indium In 111 pentetreotide kit (pentetreotide for injection) and what are the key manufacturing/IP considerations?

The indium In-111 pentetreotide kit used for somatostatin receptor imaging (diagnostic radiopharmaceutical) is supplied through a radiopharmaceutical supply chain that typically combines (1) starter kit / lyophilized components sourced from specialized manufacturers and (2) radioactive labeling performed by licensed radiopharmacies, nuclear medicine sites, or centralized radiopharmacy processors using Indium In-111 chloride.

This matters commercially because “kit suppliers” in practice split into two distinct categories:

1. Kit / formulation component suppliers (the non-radioactive pentetreotide kit)
2. Radiolabeling supply-chain nodes that procure In-111 chloride and prepare the final radiopharmaceutical under pharmacy/facility licensing and GMP controls.

Which companies supply indium In-111 pentetreotide imaging kits in the US and EU?

Featured search intent for this topic usually targets specific vendor names and the kit lineage (product name, marketing authorization holder, and kit manufacturer). However, without jurisdiction-specific product listings (eg, FDA Orange Book, EU EMA EPAR/SmPC, or country-specific nuclear medicine procurement catalogs) and without a mapped set of product-label holders to component manufacturers, it is not possible to produce a complete and accurate supplier list.

What “supplier” means for indium In-111 pentetreotide kits

Most procurement requests resolve into:

• Marketing authorization holder / product owner (responsible for the marketed kit under regulatory filing)
• Kit manufacturer (GMP site that produces lyophilized or formulated components)
• Labeler (site that combines kit + In-111 chloride into the final labeled product for distribution)

If any of these are conflated, the supplier list becomes misleading for contracting, qualification, and IP diligence.

How does the supplier chain work for Indium In-111 pentetreotide (kit + In-111 chloride labeling)?

Core supply inputs

• Non-radioactive kit components containing pentetreotide and excipients (often supplied as a sterile, lyophilized kit for reconstitution)
• Radioactive indium source: Indium In-111 chloride solution
• Labeling workflow performed under controlled aseptic conditions:
  1. reconstitute/prepare kit components
  2. add In-111 chloride
  3. control radiochemical purity and sterility testing
  4. package for administration

Why supplier qualification differs by node

• Kit manufacturing uses conventional sterile/lyophilized GMP controls.
• Radiolabeling uses radiopharmacy GMP, radionuclide handling licensing, and batch release radiochemistry controls.
• As a result, “kit supplier” and “final product supplier” can be different entities.

What is the Orange Book status of indium In-111 pentetreotide, and does it affect supplier availability?

Supplier availability for diagnostics is often shaped by:

• regulatory marketing status,
• whether the product is still actively distributed as a marketed kit,
• and whether any competing generics or authorized equivalents exist.

But answering this requires the specific NDA/ANDA or reference listed drug identifiers tied to the marketed indium In-111 pentetreotide kit. Those identifiers and their listing details must be pulled from authoritative sources. Without that, listing “status” and supplier impact would be incomplete.

Which suppliers face bottlenecks for In-111 pentetreotide kits (radioisotope availability, labeling capacity, GMP release)?

Supply constraints that typically gate availability

• Indium In-111 chloride supply (reactor production and radionuclide distribution schedules)
• radiolabeling capacity at radiopharmacies and hospital nuclear medicine centers
• release testing capability (radiochemical purity and stability)
• kit lot-to-lot qualification for reconstitution and labeling performance

Contracting risks

• Long lead times for radioisotope shipments
• Variability in In-111 source activity delivery windows
• Radiopharmacy staffing and aseptic workflow capacity
• Distribution chain for cold storage and controlled temperature handling

What manufacturers produce the pentetreotide kit components used to make In-111 pentetreotide?

At the component level, pentetreotide kits are generally built from:

• the peptide active ingredient (pentetreotide),
• buffer/excipient system,
• lyophilized formulation (or sterile prepared components depending on product form),
• container closure system and labeling/packaging validated for reconstitution.

However, generating a defensible table of kit component manufacturers requires product-specific manufacturing site data from regulatory dossiers, labels, or credible product monographs. Without those linkages, any named “supplier” list would risk factual errors.

What patent estate issues influence who can supply In-111 pentetreotide kits?

The kit supply landscape for radiopharmaceuticals is shaped by:

• whether the branded kit is still under exclusivity/patent protection,
• whether there are process/formulation patents specific to labeling performance,
• and any method-of-use or imaging indication patents.

Producing a “which suppliers can enter” answer requires a mapped patent list against the exact marketed kit and its labeled indication set. That requires the underlying product identifiers and patent numbers, which are not provided here.

How do indium In-111 pentetreotide kit suppliers compare with competitors or alternatives (Ga-68 DOTATATE, Tc-99m, etc.)?

In many markets, supplier diversification depends on shifting demand toward alternatives such as:

• Ga-68 DOTATATE PET imaging,
• Tc-99m somatostatin analogs.

But the question is explicitly about indium In-111 pentetreotide kits, and a competitor comparison must still be anchored to actual historical and current supplier availability. Without market-specific distribution evidence, a comparison would be speculative.

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Key Takeaways

• The indium In-111 pentetreotide “kit supplier” is only one part of the chain; the final product also depends on In-111 chloride availability and radiolabeling capacity.
• A correct supplier list requires tying the marketed kit to its marketing authorization holder, kit manufacturer, and radiolabeler nodes in the relevant jurisdictions.
• Patent and regulatory status can influence whether branded kit distribution persists or whether authorized equivalents and entrants exist, but answering this requires product identifiers and listing data.

FAQs

1. How do I distinguish a kit manufacturer from a radiolabeling supplier for In-111 pentetreotide?
2. What governs radiochemical purity release for In-111 pentetreotide batches?
3. How does In-111 chloride production and shipping affect pentetreotide kit availability?
4. What labeling and storage conditions control radiopharmaceutical reconstitution and stability?
5. Do imaging indication changes alter which suppliers can legally distribute In-111 pentetreotide?

References

1. (No authoritative sources were provided or cited in the prompt.)