Suppliers and packagers for DRAX EXAMETAZIME

DRAX EXAMETAZIME

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Jubilant	DRAX EXAMETAZIME	technetium tc-99m exametazime kit	POWDER;INTRAVENOUS	208870	NDA	Jubilant DraxImage Inc., dba Jubilant Radiopharma	65174-200-05	5 VIAL in 1 CARTON (65174-200-05) / 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL (65174-200-01)	2017-08-17

DRAXIMAGE Exametazime Suppliers and Procurement Status

Last updated: July 31, 2026

DRAXIMAGE Exametazime is a technetium-99m radiopharmaceutical kit supplied by Jubilant DraxImage Inc., part of Jubilant Radiopharma. The kit contains exametazime for reconstitution and radiolabeling with sodium pertechnetate Tc-99m. It is supplied to licensed nuclear pharmacies and hospital radiopharmacy departments rather than through ordinary pharmaceutical wholesalers.[1]

Who manufactures DRAXIMAGE Exametazime?

Product	Active component	Manufacturer or marketer	Dosage form	Primary market
DRAXIMAGE Exametazime	Exametazime, 500 micrograms per vial	Jubilant DraxImage Inc.	Sterile lyophilized kit for Tc-99m labeling	Canada
CERETEC	Exametazime, 500 micrograms per vial	GE HealthCare, through its radiopharmaceutical business	Sterile lyophilized kit for Tc-99m labeling	United States and selected international markets

Jubilant DraxImage Inc. is the identified manufacturer and Canadian product sponsor for DRAXIMAGE Exametazime. The company’s Canadian address is 16751 Trans-Canada Highway, Kirkland, Quebec.[1]

DRAXIMAGE Exametazime is not the same commercial product as CERETEC, although both contain exametazime and are used to prepare technetium Tc-99m exametazime injections.

Where can DRAXIMAGE Exametazime be purchased?

DRAXIMAGE Exametazime is generally procured through the following channels:

1. Jubilant Radiopharma or Jubilant DraxImage direct commercial sales.
2. Licensed Canadian nuclear pharmacies.
3. Hospital radiopharmacy purchasing departments.
4. Authorized pharmaceutical or radiopharmaceutical distributors serving Canadian institutions.

The product is normally shipped through controlled radiopharmaceutical distribution channels because the finished preparation is used with radioactive technetium-99m and has specialized storage, preparation, transport, and handling requirements.

Public wholesaler listings should be verified directly before procurement. Distributor availability can change based on national supply, batch release, product allocation, and regional licensing.

What is the regulatory status of DRAXIMAGE Exametazime?

DRAXIMAGE Exametazime is a Canadian-authorized radiopharmaceutical kit. The product is reconstituted with sodium pertechnetate Tc-99m obtained from an approved generator or other licensed source before clinical use.[1]

Product characteristics

Attribute	Information
Product type	Kit for preparation of a radiopharmaceutical
Drug substance	Exametazime
Radioactive component	Technetium-99m, added at the radiopharmacy
Strength	500 micrograms per vial
Route	Intravenous after radiolabeling
Main clinical use	Cerebral perfusion imaging and leukocyte labeling
Prescription status	Institutional and prescription radiopharmaceutical use
Supply channel	Licensed radiopharmacy and hospital procurement

The kit itself is not supplied as a ready-to-inject radioactive product. Tc-99m must be added by qualified personnel under applicable radiation-safety and pharmaceutical standards.

Is DRAXIMAGE Exametazime available in the United States?

The principal U.S. commercial exametazime product is CERETEC, not DRAXIMAGE Exametazime. CERETEC is associated with GE HealthCare and is the principal U.S. reference product for exametazime-based technetium Tc-99m imaging.[2]

A Canadian-labeled DRAXIMAGE product should not be assumed to be legally interchangeable with the U.S. product. Cross-border procurement depends on FDA authorization, importer requirements, state pharmacy rules, radioactive-material licensing, and product-specific distribution controls.

U.S. alternative

U.S. product	Supplier	Relationship to DRAXIMAGE Exametazime
CERETEC	GE HealthCare	Same active drug class and radiolabeling concept; separate commercial product and regulatory authorization

What suppliers provide the technetium-99m component?

Jubilant DraxImage supplies the exametazime kit. It does not supply all components required for the final radiopharmaceutical preparation.

Tc-99m is typically obtained separately from:

• A licensed molybdenum-99/technetium-99m generator.
• A commercial radiopharmaceutical manufacturer.
• A hospital-based nuclear pharmacy.
• A regional radiopharmacy licensed to handle and dispense Tc-99m.

The relevant supplier for Tc-99m depends on the hospital’s generator contract, radiopharmacy network, geography, and delivery schedule. Exametazime kit procurement and Tc-99m procurement are therefore separate purchasing decisions.

What companies compete with Jubilant DraxImage in exametazime?

The principal branded competitor is GE HealthCare with CERETEC.

Company	Product	Market position
Jubilant Radiopharma	DRAXIMAGE Exametazime	Canadian exametazime kit
GE HealthCare	CERETEC	Major international and U.S. exametazime kit
Hospital or compounding radiopharmacy	Locally prepared Tc-99m-labeled leukocytes, where permitted	Service-based alternative rather than a direct commercial kit

The competitive landscape is limited because exametazime is a specialized nuclear-medicine product. Supply decisions are affected by regulatory approval, radioactive-material licensing, short product-use windows, radiopharmacy capability, and local distribution infrastructure.

What should buyers verify before ordering DRAXIMAGE Exametazime?

Institutional buyers should verify the following commercial and regulatory points with Jubilant or the authorized distributor:

Procurement issue	Required verification
Product identity	DRAXIMAGE Exametazime, 500-microgram vial
Market authorization	Canadian authorization and current product status
Package configuration	Number of vials per pack and kit contents
Expiry	Kit expiry and post-reconstitution use period
Storage	Label-directed storage conditions
Radioactive material	Separate Tc-99m source and licensed handling
Delivery	Radiopharmaceutical logistics and delivery window
Quality documentation	Lot number, certificate documentation, and release information
Institutional eligibility	Hospital or nuclear-pharmacy licensing
Substitution	Whether CERETEC or another product is acceptable under institutional protocols

Does DRAXIMAGE Exametazime have generic suppliers?

No conventional generic supplier should be assumed for DRAXIMAGE Exametazime. Commercial availability is concentrated in branded exametazime kits, particularly DRAXIMAGE Exametazime and CERETEC. Any alternative must be assessed for:

• Active ingredient and vial strength.
• Approved radiolabeling procedure.
• Indications and labeling.
• Regulatory jurisdiction.
• Stability and radiochemical purity requirements.
• Institutional nuclear-medicine protocols.

A hospital-prepared radiolabeled product may be a service alternative in some jurisdictions, but it is not automatically a generic equivalent to DRAXIMAGE Exametazime.

Key Takeaways

• Jubilant DraxImage Inc. is the identified manufacturer and Canadian supplier of DRAXIMAGE Exametazime.
• The product is a 500-microgram exametazime kit used with sodium pertechnetate Tc-99m.
• Procurement is normally through Jubilant Radiopharma, licensed nuclear pharmacies, hospital radiopharmacies, or authorized radiopharmaceutical distributors.
• CERETEC from GE HealthCare is the principal branded alternative, particularly in the United States.
• Tc-99m is sourced separately from a licensed generator or radiopharmacy.
• Product availability, importation, and substitution must be confirmed for the specific country and institution.

FAQs About DRAXIMAGE Exametazime Suppliers

Who is the direct supplier of DRAXIMAGE Exametazime in Canada?

Jubilant DraxImage Inc., operating within Jubilant Radiopharma, is the direct manufacturer and commercial supplier identified in the Canadian product monograph.[1]

Is DRAXIMAGE Exametazime sold through regular pharmacy wholesalers?

It is generally distributed through specialized radiopharmaceutical channels, licensed nuclear pharmacies, and hospital radiopharmacy departments rather than ordinary community-pharmacy wholesalers.

What is the U.S. equivalent of DRAXIMAGE Exametazime?

CERETEC, supplied by GE HealthCare, is the principal U.S. commercial exametazime kit.

Does the DRAXIMAGE kit include technetium-99m?

No. The kit contains exametazime reagents. Sodium pertechnetate Tc-99m is added separately by an authorized radiopharmacy.

Can a hospital import DRAXIMAGE Exametazime from Canada?

Importation depends on the destination country’s drug, radioactive-material, customs, and pharmacy rules. Canadian authorization alone does not establish authorization for sale or use in another jurisdiction.

References

1. Jubilant DraxImage Inc. (n.d.). DRAXIMAGE Exametazime: Product monograph. Health Canada Drug Product and Compiance Directorate.

2. GE HealthCare. (n.d.). CERETEC exametazime kit for the preparation of technetium Tc 99m exametazime injection: Prescribing information. U.S. Food and Drug Administration labeling database.