Suppliers and packagers for generic pharmaceutical drug: iobenguane sulfate i-123

iobenguane sulfate i-123

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Ge Healthcare	ADREVIEW	iobenguane sulfate i-123	SOLUTION;INTRAVENOUS	022290	NDA	Medi-Physics Inc.	17156-235-01	1 VIAL, GLASS in 1 CONTAINER (17156-235-01) / 5 mL in 1 VIAL, GLASS	2008-09-19

Suppliers and packagers for generic pharmaceutical drug: iobenguane sulfate i-123

Last updated: June 3, 2026

Iobenguane Sulfate I-123 Suppliers: Who Manufactures and Supplies This FDA-Approved Radiopharmaceutical?

Iobenguane sulfate I-123 (diagnostic radiopharmaceutical; iodine I-123, microencapsulated) is supplied through a limited number of qualified radiopharmaceutical manufacturers and specialty distributors tied to the product’s FDA authorization and nuclear medicine distribution chain. Because supply is constrained by radionuclide procurement, sterile radiopharmaceutical manufacturing capacity, and cold-chain logistics, supplier lists in practice map to the licensed radiopharmacy network that can reconstitute and dispense under FDA labeling and applicable state rules.

Which companies supply iobenguane sulfate I-123 for hospitals and radiopharmacies?

Featured-snippet answer: The practical “suppliers” are the licensed radiopharmaceutical manufacturers holding the FDA NDA/labeling authorization for iobenguane sulfate I-123 and the specialty nuclear distribution companies that ship to authorized radiopharmacies and imaging centers.

Common supply-chain roles (how iobenguane sulfate I-123 gets to patients)

• Manufacturers (radio-pharma producers): Produce iobenguane sulfate I-123 as a sterile, labeled radiopharmaceutical product (including container preparation, QC release, and radionuclide-specific batch controls).
• Specialty distributors: Handle regulated distribution of short-lived radionuclides (temperature control, chain-of-custody, radiation safety documentation).
• Authorized radiopharmacies / nuclear medicine providers: Receive the product and administer it to patients under provider licensure and radiopharmacy standards.

Supplier identification method used in procurement

Organizations typically source via:

• FDA labeling and package insert supply info (manufacturer/distributor names and ordering channels)
• Nuclear medicine wholesaler catalogs (only those with validated lanes for I-123)
• Institutional purchasing contracts with radiopharma suppliers/distributors

What is the FDA and labeling supply footprint for iobenguane sulfate I-123?

Featured-snippet answer: The labeling for iobenguane sulfate I-123 contains the NDA/label holder and the named manufacturer/distributor responsible for the marketed radiopharmaceutical. That labeling footprint is the controlling reference for contracting and for inventory substitutions.

What to look for on the package insert

• Label holder/manufacturer identity
• Distribution/distributor name(s)
• Ordering address/phone and special handling
• Unit-of-use presentation (vial strength and kit configuration as applicable)

How many suppliers can realistically provide iobenguane sulfate I-123 in the US?

Featured-snippet answer: The number of true “market suppliers” is small, while the number of “ordering points” is larger due to radiopharmacy networks and specialty distributors.

Why the supplier base is narrow

• Short-lived radionuclide supply and tight QC release windows
• Sterile radiopharmaceutical manufacturing and release capacity limits
• Radiation safety handling and shipping constraints
• Limited authorized distribution partners and restricted cold-chain lanes

Where do iobenguane sulfate I-123 suppliers ship from, and how is cold chain handled?

Featured-snippet answer: Shipment lanes are constrained to regulated cold-chain and radiation-compliant workflows, typically from manufacturer or authorized regional distribution hubs to licensed radiopharmacies and hospitals.

Logistics requirements affecting supplier qualification

• Radiation safety documentation and chain-of-custody
• Time-on-route limits driven by radionuclide half-life
• Temperature and container integrity checks
• Receiving and inventory logging protocols at the radiopharmacy

What supply risks exist for iobenguane sulfate I-123 (backorders, allocation, shortages)?

Featured-snippet answer: Supply risk is dominated by radionuclide availability, batch release timing, and radiopharma manufacturing capacity rather than typical API or sterile fill-finish bottlenecks.

Risk drivers that show up in procurement

• Batch release delays caused by QC/sterility or radionuclide potency testing windows
• Radionuclide production schedule changes
• Distribution partner capacity constraints
• Demand spikes tied to imaging volumes

How does iobenguane sulfate I-123 supplier selection work for hospitals and IDNs?

Featured-snippet answer: Buyers qualify suppliers based on delivery reliability, validated radiation-handling procedures, and contract terms that cover short lead times and dose-specific ordering.

Procurement controls used by IDNs

• Single-source vs multi-source contracting for dose-critical imaging
• Service-level requirements (on-time delivery, lot tracking, recall procedures)
• Substitution policy for equivalent radiopharmaceutical presentations only when labeling permits
• Contract pricing tied to administered dose ordering model

Key Takeaways

• iobenguane sulfate I-123 has a constrained supplier market in practice because radionuclide supply, sterile radiopharmaceutical manufacturing, and regulated nuclear distribution limit the number of real manufacturers and credible distribution partners.
• For high-stakes contracting and dispensing operations, the controlling “supplier” reference is the drug’s FDA labeling footprint (manufacturer and distributor named in the package insert).
• Hospital and radiopharmacy procurement focuses on logistics reliability and radiation-compliant delivery, not only unit price.

FAQs

1. How do I confirm the correct manufacturer/distributor for iobenguane sulfate I-123 before placing an order?
   Check the product labeling/package insert and the exact vial/kit labeling on the received unit and purchase order.

2. Can radiopharmacies administer iobenguane sulfate I-123 from any distributor?
   Only distributors delivering from appropriately authorized supply chains consistent with the labeled product and receiving facility licensure.

3. What causes shipment delays for iobenguane sulfate I-123 more often than “standard” drug shortages?
   Radionuclide production schedules and radiopharmaceutical batch release timing.

4. How should hospitals manage inventory planning for a short-lived radiopharmaceutical like I-123 iobenguane?
   Use dose-time windows, confirmed lot/expiry handling procedures, and multi-lane distribution coverage where contracts permit.

5. What documentation should a hospital expect from iobenguane sulfate I-123 suppliers?
   Lot traceability and radiation safety shipping/receiving documentation consistent with regulated nuclear distribution.

References

1. FDA. Drug Approval Package for Iobenguane I-123 (as applicable in FDA records). U.S. Food and Drug Administration.
2. FDA. Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book). U.S. Food and Drug Administration.
3. FDA. Radiopharmaceutical guidance and current good manufacturing practice and distribution requirements (as applicable). U.S. Food and Drug Administration.