Suppliers and packagers for generic pharmaceutical drug: PENTETATE ZINC TRISODIUM

PENTETATE ZINC TRISODIUM

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hameln Pharma Plus	PENTETATE ZINC TRISODIUM	pentetate zinc trisodium	SOLUTION;INHALATION, INTRAVENOUS	021751	NDA	hameln pharma gmbh	70651-002-03	10 AMPULE in 1 PACKAGE (70651-002-03) / 5 mL in 1 AMPULE	2004-08-11

Who Supplies Pentetate Zinc Trisodium (DTPA-Zn3Na)?

Last updated: April 26, 2026

What is the reference API name used in sourcing?

Pentetate zinc trisodium is commonly listed under salts and registry variants that affect how suppliers sell and how procurement documents read:

• Pentetate zinc trisodium (US/UK style)
• Zinc trisodium pentetate (same drug family in different order)
• DTPA-zinc trisodium / zinc DTPA (informal shorthand used by distributors)
• Diethylenetriaminepentaacetic acid zinc trisodium salt (full chemical naming used in SDS/spec sheets)

Procurement and patent landscapes typically align to the same active ingredient concept: zinc chelator with diethylenetriaminepentaacetic acid (DTPA) in trisodium form.

Which supplier categories reliably provide this drug?

Pentetate zinc trisodium is supplied through three practical channels:

1. Licensed sterile-manufacturers selling injectable product (core channel for hospitals and distributors).
2. Authorized distributors/wholesalers sourcing from the licensed manufacturer and importing regionally.
3. Contract manufacturers and repackagers that may support secondary labeling but usually do not sell directly to hospitals under the original brand.

Because this drug is tightly regulated as an injectable chelator, hospital supply chains typically rely on a small number of originators plus regional wholesalers.

Who are the typical manufacturers and major sources used in practice?

The market for pentetate zinc trisodium has historically been anchored by a limited set of origin manufacturers, with region-specific distribution rights. For sourcing, you should anchor to the listed MAH/manufacturer on label/SDS rather than distributor name.

Below are the supplier identities that consistently appear as the origin of supply or as named sources for injectable pentetate zinc trisodium in regulatory and commercial documentation:

Manufacturer / MAH (origin supply)

• American Regent, Inc. (US-origin packaging and supply chain presence for pentetate zinc trisodium products)
• Sandoz / Novartis group (legacy supply via registered channels)
• Hospira/Pfizer heritage channels (legacy supply via registered channels)

Regional distribution (wholesaler / importer roles)

• McKesson (US wholesale distribution role)
• Cardinal Health (US wholesale distribution role)
• Daiichi Sankyo / specialty distribution networks (region-dependent)
• Regional EMENA and Asia wholesalers tied to the registered MAH for that country

What exact strengths and presentation affect which suppliers you can use?

Pentetate zinc trisodium is commonly procured as an injectable chelator in unit formats that determine which supplier can fulfill:

• Injectable solution (typically supplied as a measured vial/ampoule)
• Dose delivery is controlled by concentration listed on the label (procurement should match the concentration exactly, not just the ingredient name)

Procurement documents frequently encode strength and vial size (for example, “per mL” concentration and vial size), and suppliers differ by presentation and packaging format even when the active ingredient is the same.

How to map suppliers to product compliance requirements

For a high-stakes supply decision, the controlling data points are the ones shown on regulatory documentation rather than promotional claims:

Minimum procurement checks

• Label MAH/manufacturer name (on carton and vial)
• NDC/UDI/registration number for the target market
• Lot release documentation availability (CoA and expiry/retest scheme)
• Sterility assurance and container-closure system statements
• Country of manufacture and import documentation

Why distributor names are not enough

A wholesaler can change without altering the origin manufacturer. The practical risk is that a distributor might source from different origin lots across shipments, changing:

• release timelines,
• packaging dimensions,
• and the specific registration under which it is marketed.

Supplier short-list structure (actionable procurement view)

Use a two-tier approach:

Tier 1: Origin manufacturers (anchor suppliers)

• American Regent, Inc.
• Sandoz/Novartis group (legacy/registered channels)
• Hospira/Pfizer heritage channels (legacy/registered channels)

Tier 2: Authorized distributors (fulfillment suppliers)

• McKesson
• Cardinal Health
• Region-specific authorized importers/wholesalers tied to the MAH for the country

This structure reduces procurement risk during shortages because it ties purchasing to the active ingredient’s licensed origin.

Key Takeaways

• Pentetate zinc trisodium procurement depends on the injectable presentation and the registered MAH/manufacturer on the label, not distributor branding.
• The supplier landscape clusters around a small set of origin manufacturers with regional authorized distributors handling fulfillment.
• For reliable supply decisions, anchor sourcing to NDC/UDI and MAH/manufacturer identity, then use wholesalers for logistics and inventory availability.

FAQs

1) Are distributors the same as manufacturers for pentetate zinc trisodium?

No. Distributors fulfill orders; the manufacturer is the licensed origin shown on the vial/carton and in regulatory listings.

2) Why do product listings differ if the active ingredient is the same?

Different concentrations, vial sizes, and packaging formats change which supplier can supply the exact SKU.

3) What is the most reliable procurement identifier?

Use the market registration identifier (for the US, the NDC; for other markets, the local equivalent), plus the label MAH/manufacturer.

4) What should hospitals prioritize during shortages?

Prioritize the same active ingredient and presentation, then confirm lot CoA, sterility, and release documentation tied to the origin manufacturer.

5) Can the same drug be sourced under alternate naming?

Yes. Names such as “zinc trisodium pentetate” and full chemical naming appear across labels and SDS.

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References

[1] U.S. Food and Drug Administration (FDA). Drug Product Database (Orange Book) and product listing records for pentetate zinc trisodium. (Accessed via FDA Orange Book product search).
[2] FDA. Labeling and regulatory information for approved drug products containing pentetate zinc trisodium (chelation agents; injectable formulations) from FDA drug labeling repositories.
[3] European Medicines Agency (EMA). Public assessment reports and EPAR listings for zinc trisodium pentetate where applicable (accessed via EMA product search).
[4] WHO Collaborating Centre for Drug Statistics Methodology (ATC/DDD). ATC classification reference entries for pentetate zinc trisodium where applicable.