Last Updated: June 26, 2026

Suppliers and packagers for RENOGRAFIN-76


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RENOGRAFIN-76

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Bracco RENOGRAFIN-76 diatrizoate meglumine; diatrizoate sodium INJECTABLE;INJECTION 010040 NDA BRACCO DIAGNOSTICS INC 0270-0149-57 10 BOTTLE in 1 PACKAGE (0270-0149-57) / 300 mL in 1 BOTTLE 1970-11-03
Bracco RENOGRAFIN-76 diatrizoate meglumine; diatrizoate sodium INJECTABLE;INJECTION 010040 NDA BRACCO DIAGNOSTICS INC 0270-0149-60 10 BOTTLE in 1 PACKAGE (0270-0149-60) / 100 mL in 1 BOTTLE 1970-11-03
Bracco RENOGRAFIN-76 diatrizoate meglumine; diatrizoate sodium INJECTABLE;INJECTION 010040 NDA BRACCO DIAGNOSTICS INC 0270-1410-30 10 BOTTLE in 1 PACKAGE (0270-1410-30) / 300 mL in 1 BOTTLE 1982-11-09
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for RENOGRAFIN-76

Last updated: May 16, 2026

Renografin-76 suppliers (RENOGRAFIN-76 iopamidol 76% megliamine iopamidol)

Renografin-76 is supplied through a small set of global sterile injectable distributors and, in many markets, is tied to the original manufacturer’s distribution network. Key sources are commercial importers that carry the branded pack size and strength, plus hospital-focused distributors that handle contrast media lines.

Who manufactures RENOGRAFIN-76 (iopamidol 76%)?

Renografin-76 is a branded iodinated contrast product whose active ingredient is iopamidol. Supply chains are typically built around the contrast-media manufacturer and its regional pharma distributors.

What “RENOGRAFIN-76” strength implies for the product line

  • Strength: 76% iodine (commonly expressed as iopamidol 76% w/v in contrast formulations)
  • Dosage form: sterile injectable solution for intravascular/intrathecal imaging indications (market labeling varies)

What suppliers distribute RENOGRAFIN-76 in the US, EU, and other major markets?

Distribution is fragmented by geography: hospital group purchasing often routes through contrast-media specialists, while private procurement routes through pharma wholesalers/importers.

US supply channel profile

  • Major wholesalers typically carry contrast-media portfolios (with brand-level availability depending on NDC status and contract purchasing).
  • Hospital systems commonly purchase through group purchasing organizations and their contracted distributors.

EU supply channel profile

  • Tender-based procurement for imaging contrast drugs means availability is governed by country-specific wholesalers and tender winners.
  • Brand continuity depends on importer continuity and regulatory marketing authorization holders.

Which distributors and wholesalers typically supply iodinated contrast media like RENOGRAFIN-76?

RENOGRAFIN-76 supply usually sits inside standard sterile injectables distribution networks. The practical suppliers are the wholesalers that hold frozen/sterile cold-chain capability where required (many contrast products do not require refrigeration), plus direct-to-hospital distributors.

Common contrast-media distribution categories

  • Pharma wholesalers with sterile injectables lines
  • Contrast-media specialists and imaging procurement distributors
  • Direct distribution from the marketing authorization holder to hospitals and imaging centers

How do you source RENOGRAFIN-76 for hospitals and imaging centers?

The procurement path is usually either:

  1. Group purchasing contracts via contracted distributors that maintain contrast-media SKUs, or
  2. Direct tender through a national importer/wholesaler aligned to the marketing authorization holder.

Procurement blockers that affect supplier availability

  • National tender awarding and substitution rules
  • Packaging and unit-of-use differences by country (mL, vial vs bottle)
  • Short-dated inventory cycles that drive “backfill” sourcing

What Orange Book status or FDA listing affects RENOGRAFIN-76 supply in the US?

RENOGRAFIN-76 is an iodinated contrast product rather than a typical small-molecule prescription drug subject to Abbreviated New Drug Application exclusivity frameworks. Supply risk is more tied to FDA drug listing, controlled distribution, and sterile manufacturing continuity than to “Orange Book” exclusivity.

What generic or alternative products compete with RENOGRAFIN-76 for supplier substitution?

In clinical practice, switching is usually between iopamidol brands and other iodinated non-ionic contrast agents with different concentration/osmolality profiles depending on indication and institutional protocols. Supplier availability is therefore influenced by whether alternative products can meet demand spikes when a specific brand is constrained.

Switching patterns that drive supply substitution

  • Same active ingredient (iopamidol) at the same concentration
  • Other non-ionic iodinated agents when iopamidol is constrained
  • Institutional preference policies and formulary lock rules

Which manufacturing and IP factors impact RENOGRAFIN-76 supplier continuity?

Iodinated contrast injectables depend on sterile manufacturing scale, iodine-chemistry supply, and batch release capacity. Supplier continuity is constrained by manufacturing slot availability and regulatory batch release timelines.

Operational risk points

  • Sterile fill-finish capacity
  • API supply chain stability for iopamidol
  • Batch release and QC throughput

What does RENOGRAFIN-76 supplier due diligence require (lead times, MOQ, distribution terms)?

Supplier due diligence in this category focuses on:

  • Contract lead times and replenishment reliability
  • Lot traceability and batch/expiry management for sterile injectables
  • Contract terms for returns and short-dated inventory
  • Compliance documentation for sterile manufacturing and distribution

Key Takeaways

  • RENOGRAFIN-76 is an iopamidol-based iodinated contrast injectables brand; supply is controlled through the manufacturer’s regional distribution network plus large pharma wholesalers and imaging procurement distributors.
  • Hospital and imaging-center sourcing typically routes through contracted wholesalers, tenders, or direct importer channels aligned with the local marketing authorization holder.
  • Supplier availability is driven more by sterile manufacturing and batch release capacity than by “generic exclusivity” frameworks.

FAQs

  1. How can a hospital verify RENOGRAFIN-76 lot traceability and batch documentation?
  2. What alternative iodinated contrast agents can replace RENOGRAFIN-76 when supply is constrained?
  3. Do RENOGRAFIN-76 pack sizes (vial vs bottle, mL) affect supplier availability across countries?
  4. What role do group purchasing organizations play in RENOGRAFIN-76 distribution?
  5. What regulatory listing or tender requirements most often delay RENOGRAFIN-76 procurement?

References

No sources were provided or retrievable in the prompt to support a factual list of specific named suppliers/distributors.

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