Suppliers and packagers for generic pharmaceutical drug: gallium dotatate ga-68

gallium dotatate ga-68

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Aaa Usa Inc	NETSPOT	gallium dotatate ga-68	POWDER;INTRAVENOUS	208547	NDA	Advanced Accelerator Applications USA, Inc	69488-001-40	1 KIT in 1 KIT (69488-001-40) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, SINGLE-DOSE	2016-06-01

Gallium Ga-68 Dotatate (GA-68 DOTATATE) Suppliers: Who Manufactures, Licenses, and Supplies the FDA-Ready Radiopharmaceutical Supply Chain

Last updated: May 24, 2026

What companies supply Gallium Ga-68 dotatate for clinical use in the US and EU?

Gallium Ga-68 dotatate (commonly marketed as DOTATATE GA 68, and in some markets as NETSPOT-compatible products) is supplied as a ready-to-use or kit-based radiopharmaceutical that depends on local labeling, distribution, and cyclotron or generator workflows. The supplier set in practice is narrower than the broader “pet radiopharmaceutical” field because Ga-68 dotatate is tightly tied to production capacity (generator availability), radiolabeling/kit manufacturing, and FDA/NMPA batch release.

Key supplier archetypes

1. Radiopharmaceutical manufacturer/label holder (owns the marketed product and quality release for each lot).
2. Gallium-68 generator supplier / generator workflow operator (enables Ga-68 feedstock).
3. Radiopharmacy that reconstitutes/labels (where applicable under local regulations).
4. Distributors and authorized nuclear medicine centers (local logistics and cold-chain handling).

US supply reality In the US, Ga-68 dotatate is supplied through radiopharmaceutical product channels tied to FDA-approved labeling and lot release. The US supplier set is dominated by manufacturers with the product NDA/BLA labeling and the radiopharmacy partners that fulfill institutional demand.

EU supply reality In the EU, commercial availability varies by country and relies on NCA release, local GMP release sites, and radiopharmacy distribution networks. Multiple companies can appear in listings because of local marketing authorizations even when the underlying product manufacture is concentrated.

Actionable supplier due diligence for procurement teams

• Confirm whether you need commercial manufactured product versus kit + local Ga-68 generator workflow.
• Validate:
  • labeling route (institutional vs hospital pharmacy use),
  • lot release responsibility in your country,
  • generator compatibility standards and isotope availability windows,
  • shipping lane stability and lead times under short half-life logistics.

What manufacturers make the kit or finished dose for Ga-68 dotatate?

Ga-68 dotatate products are typically supplied as:

• a prefilled/ready-to-use dose, or
• a kit intended for radiolabeling/reconstitution at a radiopharmacy using Ga-68.

In practice, only a limited number of manufacturers hold the capability to produce and release:

• GMP radiopharmaceutical kits or labeled sterile doses,
• stable packaging for Ga-68 logistics,
• validated assay methods, sterility/endotoxin controls,
• batch release documentation suitable for nuclear medicine settings.

Procurement checklist

• Source documentation: certificate of analysis (CoA) and release testing (sterility/endotoxin/radionuclidic purity/radiochemical purity).
• Expiry and maximum allowed time from compounding to administration.
• Packaging size options (patient dose vs multi-dose formats).

Are there multiple branded versions of Ga-68 dotatate, and who are their label holders?

Different regions list Ga-68 dotatate under different brand names tied to local marketing authorization holders. For procurement and contracting, the key determinant is the label holder for your market because it controls:

• availability under national pricing/reimbursement regimes,
• lot release obligations,
• adverse event and batch recall responsibility,
• and the “compatible substitution” position with payers and regulators.

Contracting implication: treat “supplier” as “authorized label holder” for your territory, not merely the distributor.

What is the Ga-68 dotatate supply chain model: manufacturer vs distributor vs radiopharmacy?

The supply chain for Ga-68 dotatate usually splits into these layers:

1) Isotope supply (Ga-68 generator workflow)

• Ga-68 is supplied via Ge-68/Ga-68 generator systems or through production pathways in some markets.
• Generator availability can be a gating item during supply disruptions.

2) Radiolabeling and product assembly

• For kit-based routes, radiopharmacies assemble doses close to administration time.
• For ready-to-use routes, manufacturers ship finished doses and radiopharmacies administer.

3) Logistics for a short half-life isotope

Ga-68 has a short half-life (about 68 minutes). Supplier performance depends on:

• same-day delivery windows,
• validated shipping temperatures and packaging,
• rapid receiving and dose preparation processes.

When do Ga-68 dotatate supply shortages occur and what mitigation works?

Supply constraints typically correlate with:

• generator supply or generator fielding delays,
• manufacturing batch timing and release backlogs,
• regulatory batch release pauses,
• transport interruptions affecting short shelf-life logistics.

Mitigation that maps to actual procurement levers

• Multi-source contracting for either:
  • generator workflow, and/or
  • finished dose or kits, depending on your radiopharmacy model.
• Buffer inventory at the radiopharmacy level consistent with on-hand compounding capacity and validated administration window.
• Pre-arranged cold-chain receiving SLAs with distributors.

Who supplies Gallium-68 generators used for dotatate production?

Because Ga-68 generator availability impacts the ability to produce Ga-68 dotatate kits locally, procurement teams often need both:

• the Ga-68 dotatate kit/finished dose supplier, and
• a reliable generator supplier or generator workflow partner.

Key due diligence

• generator model compatibility with the label’s recommended compounding method,
• delivered generator yield profile and validation,
• generator exchange schedule and service coverage in your region,
• lot traceability and radionuclidic purity compliance.

How does distributor coverage affect which suppliers hospitals can actually buy from?

Hospital buying is often constrained by:

• distributor authorization status,
• regional service coverage,
• refrigerated/shipping qualification,
• and the radiopharmacy’s operational model.

As a result, a label holder might sell through a limited set of authorized distributors, meaning “supplier choice” for hospitals is effectively a distributor list.

How strong are supplier alternatives for Ga-68 dotatate if one manufacturer is unavailable?

In radiopharmaceuticals with short-lived isotopes, alternative sourcing is frequently limited by:

• synchronized generator supply,
• validated radiolabeling SOP alignment,
• bridging documentation required by hospital quality systems,
• and label-based substitution rules in your jurisdiction.

The practical alternative assessment is:

• How quickly you can switch to an alternate kit/finished dose supplier while keeping compliance for radiochemical purity, sterility, and dose timing.
• Whether the alternate supplier supports your facility’s compounding workflow without revalidation delays.

What FDA regulatory status affects supplier availability for Ga-68 dotatate?

In the US, supplier availability is tied to:

• FDA-approved product labeling,
• current manufacturing site status,
• and lot release compliance under FDA oversight.

Procurement impact:

• if a supplier’s product has manufacturing or quality issues, distribution can stop quickly because radiopharmaceutical lot release is not interchangeable across label holders.

Which countries have the tightest Ga-68 dotatate sourcing constraints?

Countries with:

• limited generator infrastructure,
• few authorized radiopharmacies,
• or constrained transport lanes under short isotope half-life tend to face the most fragile supply. The supplier list also differs because marketing authorization holders vary by territory.

Supplier risk matrix for Ga-68 dotatate (what to score in vendor qualification)

Use the following scoring to rank supplier bids in a procurement process:

Risk dimension	What to verify with suppliers	High-risk signals
Lot release reliability	historical release cadence, QA consistency, batch documentation	frequent holds, delayed CoAs, limited QA transparency
Isotope workflow continuity	generator partnership/service, generator lead time	generator shortages, weak service coverage
Shipping performance	delivery SLAs, validated packaging, receiving windows	missed delivery windows, inconsistent packaging
Clinical operations compatibility	kit/label fit with SOPs, compounding windows	frequent dose preparation failures or out-of-spec results
Regulatory standing	manufacturing and distribution compliance	recurrent quality notifications affecting releases

Key takeaways

• Ga-68 dotatate supply is constrained by label holder manufacturing capacity, Ga-68 generator workflow, and short half-life logistics.
• For procurement decisions, “supplier” should be defined as the authorized label holder for your territory plus the authorized distributor/radiopharmacy pathway that can meet receiving and dose-prep windows.
• Supplier redundancy typically requires multi-source planning across either finished dose/kit supply and/or generator workflow, not only distributor substitutions.

FAQs

1. Can a hospital switch Ga-68 dotatate suppliers without revalidating radiopharmacy procedures?
2. What Ga-68 generator yield and radionuclidic purity specs matter for dotatate kit performance?
3. Do distributor authorization restrictions limit Ga-68 dotatate purchasing options in the US?
4. How should procurement define “approved substitutes” for Ga-68 dotatate under local nuclear medicine QA?
5. What lead times are realistic for Ga-68 dotatate kits versus ready-to-use doses during generator shortages?

References

1. FDA. “NDC/Drug Label Information for Gallium Ga 68 Dotatate.” U.S. Food and Drug Administration (accessed via FDA labeling/NDC lookups).
2. EMA. “Product Information for Gallium (68Ga) Edotreotide/dotatate-containing Radiopharmaceuticals.” European Medicines Agency (accessed via EPAR/SmPC lookups).