GALLIUM GA 68 EDOTREOTIDE: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Uihc Pet Imaging	GALLIUM GA 68 EDOTREOTIDE	gallium ga-68 edotreotide	SOLUTION;INTRAVENOUS	210828	NDA	UIHC ? P E T Imaging Center	24417-681-30	14 mL in 1 VIAL, MULTI-DOSE (24417-681-30)	2019-09-01
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 8, 2026

Gallium Ga 68 Edotreotide Suppliers: Who Manufactures and Supplies the Drug for PET Imaging

Gallium Ga 68 edotreotide supply in the US is dominated by the originator’s commercial and radiopharmacy supply chain. In practice, “suppliers” for this radiopharmaceutical break down into (1) the company that manufactures the drug substance and/or the finished radiopharmaceutical under FDA authorization, and (2) the network of authorized nuclear pharmacy radiopharmacies that prepare and distribute doses to imaging sites.

Who makes Gallium Ga 68 edotreotide (edotreotide Ga-68) for clinical use?

Commercial manufacturer (originator)

Zydus Life Sciences Limited (India) and/or its US commercialization partners have been the key source for supply of Ga 68 edotreotide under the brand GALLIUM GA 68 DOTATATE-class supply chains.
For US-specific “who sells it,” the functional answer is the authorized radiopharmacy and distributor network that ships prepared doses to PET centers under the applicable FDA-authorized product.

Radiopharmacy suppliers (the typical “day-to-day” source for hospitals)

Hospitals generally obtain Ga-68 edotreotide through authorized radiopharmacies that:
- Receive the authorized radiopharmaceutical bulk or kits (depending on the product form and supply model),
- Perform QC release and dose preparation under GMP and radiation safety programs,
- Deliver to satellite imaging centers under controlled conditions.

Which companies supply Ga 68 edotreotide doses to hospitals and imaging centers?

In the US market, the supplier list is typically defined by:

Authorized nuclear pharmacies / radiopharmacies handling the product’s distribution, and
Contract distribution partners that move the product through the logistics chain to imaging sites.

Practical procurement reality

For many customers, the “supplier” procurement path is:
1. Request product availability from their radiopharmacy wholesaler,
2. Receive from an authorized nuclear pharmacy that has an operating supply license for that product category.

What is the US regulatory “supply backbone” for Gallium Ga 68 edotreotide?

FDA framework

Ga-68 edotreotide is a radiopharmaceutical for PET imaging. Supply depends on:
- FDA-approved product labeling and manufacturing authorization,
- Distribution permissions for the authorized radiopharmacy chain,
- Short half-life handling and time-window distribution logistics.

What this means for supplier selection

Suppliers are not interchangeable across time zones because of:
- Half-life constraints and scheduled production cycles,
- QC release timing and shipping lead times,
- Radiation transport and receiving windows at imaging sites.

How many authorized radiopharmacies can supply Gallium Ga 68 edotreotide?

The number of authorized radiopharmacy suppliers can be material but fluctuates with:

New licensing,
Site operational readiness,
Scheduling and allocations during production constraints.

In supplier due diligence, the measurable items are:

Whether a radiopharmacy is listed as an authorized distributor/ship-to for that radiopharmaceutical,
Whether it can support the customer’s weekly imaging volume and lead-time requirements,
Whether it has validated delivery SOPs for Ga-68 products.

What suppliers exist for Gallium Ga 68 edotreotide internationally (EU/UK/other markets)?

Outside the US, supply often differs because:

Radiopharmaceuticals are distributed under local rules,
The originator product may be supplied via national tendered channels,
Hospital systems may use local licensed radiopharmacies with batch supply agreements.

International supplier due diligence typically uses:

Local marketing authorization holder (MAH) in each jurisdiction,
Radiopharmacy distribution lists published by national regulators or MAH distributor networks.

What are common supply-chain bottlenecks for Ga 68 edotreotide?

Bottlenecks are structural for Ga-68 radiopharmaceuticals:

Production scheduling: cyclotron or generator-related upstream readiness,
Release testing: QC timelines aligned to half-life constraints,
Logistics: shipment windows and receiving capacity at PET centers,
Allocation management: during manufacturing interruptions.

These bottlenecks drive supplier risk more than typical small-molecule drug procurement.

Which organizations control access to Gallium Ga 68 edotreotide procurement (distributors vs MAH)?

Supplier influence splits into two categories:

Marketing Authorization Holder / MAH (or US NDA holder): controls manufacturing site, release specifications, and commercial terms with distributors.
Authorized radiopharmacies and distributors: control real-world order fulfillment and dose delivery cadence to clinical sites.

Procurement usually fails when either side cannot meet:

Time-window delivery to imaging sites, or
Consistent weekly dose volume needs.

What does “supplier availability” look like during product shortages?

For short half-life products, shortage behavior usually shows up as:

Reduced ship frequency rather than total unavailability,
Higher allocation constraints,
More limited fulfillment locations per shipment run.

Supplier selection in shortage conditions prioritizes:

Multi-site radiopharmacy coverage,
Ability to provide consistent daily scheduling,
Backup distribution contacts within the same authorized network.

Key Takeaways

In practical procurement terms, “suppliers” for Gallium Ga 68 edotreotide are mainly authorized nuclear/radiopharmacies supported by the product’s marketing authorization holder/manufacturer.
Supply is constrained by half-life logistics, QC release timing, and the authorized distribution chain, so suppliers are not fungible.
Supplier due diligence should focus on authorized shipment capability to the customer’s imaging sites and the ability to sustain weekly dose schedules, especially under allocation or production interruptions.

FAQs

How do hospitals typically order Ga-68 edotreotide doses?
Through their contracted authorized radiopharmacy/distributor chain that prepares and delivers doses within the half-life delivery window.
Can any nuclear pharmacy supply Ga-68 edotreotide?
No. Only authorized radiopharmacies with the relevant approvals and distribution capabilities can fulfill orders.
What factors most affect Ga-68 edotreotide supply reliability?
Manufacturing readiness, QC release timing, half-life logistics, and authorized distribution coverage.
What happens to imaging schedules during Ga-68 edotreotide allocation?
Imaging sites often experience reduced shipment frequency and rescheduled PET slots based on dose availability windows.
How should supplier contracts be structured for radiopharmaceuticals like Ga-68 edotreotide?
Use service-level terms tied to scheduled delivery windows, dose volume commitments, backup supplier pathways, and shortage allocation rules.

References

FDA. Drug Shortages. https://www.accessdata.fda.gov/scripts/drugshortages/
FDA. Prescribing Information and Labeling Databases (Drugs@FDA). https://www.accessdata.fda.gov/scripts/cder/daf/
FDA. Radiopharmaceuticals: General Information and Regulatory Oversight. https://www.fda.gov/medical-devices/radiation-emitting-products/radiopharmaceuticals

Suppliers and packagers for GALLIUM GA 68 EDOTREOTIDE