Suppliers and packagers for DATSCAN

DATSCAN

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 Hlthcare Inc	DATSCAN	ioflupane i-123	SOLUTION;INTRAVENOUS	022454	NDA	Medi-Physics Inc. dba GE Healthcare.	17156-210-01	1 VIAL, GLASS in 1 CONTAINER (17156-210-01) / 2.5 mL in 1 VIAL, GLASS	2011-03-01

Datscan (ioflupane I 123) Suppliers: Who Manufactures the Drug Product, How It Is Sourced, and What Supply Risks Matter

Last updated: May 31, 2026

Datscan is supplied in the US as a radiopharmaceutical, ioflupane I 123 injection. The practical supplier universe is constrained to (1) the US marketing authorization holder listed on FDA records, (2) the radiopharmacy distribution channel that receives product and prepares administrations, and (3) upstream suppliers of critical inputs, including iodine-123 and GMP-manufactured precursor intermediates used in ioflupane production. The supply chain is additionally shaped by cyclotron/radiochemical logistics, cold-chain storage rules, and short shelf-life.

Which companies supply Datscan (ioflupane I 123) to the US market?

In the US, Datscan is marketed under an FDA-approved application and is supplied through radiopharmacies that handle receipt, storage, and administration preparation. The “supplier” question splits into two practical tiers: the manufacturer of the drug substance/drug product and the downstream distributors that get it into clinics.

Who is the marketing authorization holder and primary supplier

• The primary branded product supplier in the US is the FDA-registered holder responsible for commercialization of Datscan (ioflupane I 123 injection).
• Downstream entities are radiopharmacies and distribution partners that receive Datscan shipments and supply nuclear medicine sites.

Radiopharmacy distribution: who actually delivers Datscan to clinics

Most US clinical administration is executed by radiopharmacies rather than general wholesalers. These organizations:

• receive Datscan from the marketing supply chain,
• perform required handling steps under validated procedures,
• coordinate delivery to nuclear medicine providers within product time windows tied to iodine-123 decay.

What is the Datscan supply chain upstream of the finished injection?

For radiopharmaceuticals, “supplier” often means multiple upstream input providers rather than a single plant.

Key upstream inputs that determine supply

1. Iodine-123 (production depends on reactor targets and Mo-123 decay pathways or cyclotron-linked production, varying by country and supply contract).
2. Ioflupane synthesis starting materials and intermediates manufactured under GMP.
3. Radiochemical processing and formulation equipment used to prepare sterile injection doses.
4. Sterile fill-finish and radiopharmaceutical QA release processes.

Why upstream supplier count is usually small

Regulatory expectations for radiopharmaceuticals, the specialized production route for iodine-123 based radiochemistry, and batch release timelines limit the number of qualifying commercial suppliers.

Which radiopharmacies commonly distribute Datscan and how does that affect procurement?

Clinical procurement is typically performed by nuclear medicine groups, hospitals, or imaging centers that order through a contracted radiopharmacy.

Procurement pattern

• Hospitals usually place orders with a radiopharmacy that has an established lane for receipt and administration scheduling.
• Radiopharmacies maintain buffer stock when clinically and logistically feasible, but shelf-life and decay mean supply is frequently “order-to-usage” rather than long-term inventory.

Operational constraints that create practical supply risk

• scheduling tight to iodine-123 activity limits
• transport time limits for dose acceptance
• capacity constraints at the radiopharmacy preparation stage during peak demand

How do iodine-123 and radiochemical logistics influence Datscan availability?

Datscan availability is sensitive to the radiochemical supply chain.

Supply bottlenecks

• reduced iodine-123 availability
• transport disruptions for time-decaying activity
• limited release capacity at radiopharmaceutical manufacturing or QC sites

Contracting implications for buyers

Buyers that diversify radiopharmacy distributors can reduce delivery risk, but diversification does not remove the upstream dependence on iodine-123 and GMP release capacity.

What manufacturing and QA steps define the supplier qualification barrier for Datscan?

Supplier qualification for radiopharmaceuticals is narrower than for conventional injectables.

Qualification drivers

• validated radiochemical identity and purity testing
• validated sterility assurance and endotoxin testing
• activity concentration measurement and dose volume validation
• batch release timing compatible with clinic administration windows

Why contract manufacturing is uncommon

Even when contract manufacturing exists, the supplier pool is limited because radiopharmaceutical production is capital- and process-intensive and tightly regulated.

Can generic or biosimilar competitors affect Datscan supply?

Datscan is not a “biologic” in the biosimilar sense. Its main competitive pressure, when any exists, would come from alternative iodine-123 labeled ioflupane products or pathway-specific competition, subject to regulatory approvals and market uptake.

Practical impact on procurement

Even if alternatives exist or are approved in some markets, US procurement is still dominated by entities that can reliably source iodine-123, manufacture under GMP, and provide radiopharmacy distribution with predictable lead times.

What supply risks exist for Datscan in the US?

Risk is best assessed across three layers: radiopharmaceutical production, radiochemistry inputs, and distribution capacity.

Top supply risk categories

• upstream iodine-123 production shortfalls
• constrained batch release capacity and QC turnaround times
• radiopharmacy scheduling capacity at major administration centers

Where buyers see the impact

• dose availability shortfall leading to rescheduling
• last-mile delivery timing issues
• increased lead times during peak demand

Supplier comparison: what differs between manufacturing suppliers and radiopharmacy distributors?

Layer	“Supplier” type	What they provide	What can constrain availability
Upstream	iodine-123 supplier(s)	raw radionuclide availability	isotope production capacity, procurement contracts
Midstream	ioflupane drug substance/intermediate suppliers	GMP intermediates	GMP approval status, batch release timing
Finished product	drug product manufacturer	sterile ioflupane I 123 doses	radiochemical processing capacity, QC release window
Downstream	radiopharmacies/distributors	delivery and administration handling	transport time limits, prep scheduling, local inventory policies

Key Takeaways

• Datscan procurement in the US is dominated by the FDA-commercial supply chain tied to the marketing authorization holder and radiopharmacy distribution partners.
• Upstream dependence on iodine-123 and radiochemical GMP release timing is the primary determinant of availability.
• “Supplier” for Datscan must be interpreted as a chain: isotope supply, radiopharmaceutical manufacturing, and radiopharmacy distribution, not just a single manufacturer name.
• Supply risk is usually expressed as short-term dose availability and scheduling rather than total market withdrawal.

FAQs

1. Is Datscan available through standard drug wholesalers?
   Usually via radiopharmacies and specialized distributors that can handle radiopharmaceutical receipt and administration logistics.

2. What is the main bottleneck for Datscan supply?
   Iodine-123 availability and radiochemical batch release capacity, followed by radiopharmacy preparation and delivery windows.

3. Do hospitals need to stock Datscan in advance?
   Many rely on radiopharmacy scheduling and short-term allocations because dose activity decays and administration timing is constrained.

4. Are there generic equivalents of Datscan that reduce supplier risk?
   Any alternative depends on regulatory approvals and practical ability to source iodine-123 and meet radiopharmacy distribution timelines.

5. What factors most influence delivery timing for Datscan doses?
   The manufacturing QC release timeline, transport time windows for iodine-123 activity, and radiopharmacy capacity for preparation.

References (APA)

1. U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. https://www.accessdata.fda.gov/scripts/cder/daf/
2. U.S. Food and Drug Administration. (n.d.). Drugs@FDA: Datscan (ioflupane I 123). https://www.accessdata.fda.gov/scripts/cder/daf/
3. U.S. Food and Drug Administration. (n.d.). Radiopharmaceuticals: current good manufacturing practice and regulation resources. https://www.fda.gov/