Suppliers and packagers for gastrografin

gastrografin

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	GASTROGRAFIN	diatrizoate meglumine; diatrizoate sodium	SOLUTION;ORAL, RECTAL	011245	NDA	Bracco Diagnostics Inc	0270-0445-35	24 BOTTLE in 1 BOX (0270-0445-35) / 30 mL in 1 BOTTLE	1958-02-26
Bracco	GASTROGRAFIN	diatrizoate meglumine; diatrizoate sodium	SOLUTION;ORAL, RECTAL	011245	NDA	Bracco Diagnostics Inc	0270-0445-40	12 BOTTLE in 1 BOX (0270-0445-40) / 120 mL in 1 BOTTLE	1958-02-26

Suppliers and packagers for gastrografin

Last updated: June 5, 2026

Gastrografin suppliers: who manufactures, supplies, and distributes amid global iodinated contrast media shortages

Gastrografin (diatrizoate meglumine and diatrizoate sodium) is an iodinated contrast medium supplied through a global network of brand owners, wholesalers, and country-level distributors. In practice, procurement depends on national tendering and import channels rather than a single worldwide “primary supplier” model, because the same active ingredient is also marketed under multiple brand and private-label equivalents across regions.

Who are the main suppliers of Gastrografin (diatrizoate) by country and distribution channel?

Featured snippet answer: Gastrografin is manufactured by the original brand supplier for iodinated contrast media and is then distributed by national wholesalers and hospital procurement distributors in each market.

Typical supplier structure for Gastrografin procurement

• Brand/marketing authorization holder (local in-region entity or importer)
• Licensed importer (where applicable)
• Hospital supply distributor (tendered channel)
• Emergency supply and secondary distributors (parallel/secondary imports, where legally permitted)

How procurement lists map to “suppliers”

In hospital tender documentation, “supplier” is often a distributor of record (tender contractor), not the manufacturing site. For iodinated contrast media, this distinction matters for lead time, lot traceability, and pharmacovigilance obligations.

Which companies supply diatrizoate meglumine/diatrizoate sodium injections equivalent to Gastrografin?

Featured snippet answer: Suppliers fall into two buckets: (1) brand-market supply chains for Gastrografin and (2) equivalent-market suppliers selling diatrizoate meglumine and diatrizoate sodium injection under other brand names or private-label equivalents.

What “equivalent” usually means in procurement

• Same active ingredients: diatrizoate meglumine and diatrizoate sodium
• Same dosage form: injection for GI/contrast imaging use (country-specific labeling)
• Matching strength and packaging (bottle size, vial size, carton configuration)

Procurement risk point

Equivalent products can differ in:

• Packaging format and size (bottle vs vial, volume per unit)
• Osmolality and labeling indications (country-specific)
• Traceability and pharmacovigilance contact

What is the manufacturing and brand ownership landscape for Gastrografin?

Featured snippet answer: Gastrografin is a legacy iodinated contrast brand whose manufacturing and authorization are managed through established pharma supply chains; ownership varies by jurisdiction due to licensing and local marketing authorizations.

Why ownership varies

• Separate entities hold marketing authorization in each country
• Local importers maintain distribution rights and pharmacovigilance reporting contacts
• Distribution may involve multiple wholesalers depending on tender awards and inventory programs

What packaging formats do suppliers offer for Gastrografin, and how does this affect ordering?

Featured snippet answer: Supplier availability is driven by bottle/vial size and case pack configuration. Hospitals should match tender product codes exactly.

Packaging attributes procurement teams track

• Unit volume per bottle/vial
• Case pack count
• Sterility and storage conditions
• Lot-to-lot shelf-life and expiration management

Which procurement routes are used to source Gastrografin for radiology and GI contrast?

Featured snippet answer: The dominant routes are framework contracts and tender-based purchasing; emergency re-supply uses secondary distributors.

Common buying paths

• National group purchasing organizations
• Direct hospital tenders for contrast media
• Distributor-managed inventory programs for radiology departments
• Emergency purchase orders during iodinated contrast supply constraints

How do suppliers handle cold-chain versus ambient storage for Gastrografin?

Featured snippet answer: Gastrografin is typically handled as an ambient-storage contrast product (storage and transport conditions follow product labeling by market authorization).

Operational implications

• Storage capacity planning differs from refrigerated biologics
• Warehouse temperature excursions are typically monitored according to labeling and GDP requirements

What are the key supplier qualification criteria for Gastrografin (GDP, traceability, pharmacovigilance)?

Featured snippet answer: Hospitals and distributors qualify suppliers using GDP compliance, lot traceability, and pharmacovigilance readiness.

Supplier qualification checklist

• GDP compliance evidence
• Lot number and expiry traceability at delivery
• Recalls and pharmacovigilance escalation process
• Label language and marketing authorization matching the destination market
• Ability to provide certificates of analysis and documentation required by local regulation

What generic and alternative iodinated contrast sourcing risks exist for Gastrografin supply?

Featured snippet answer: Substitution risk is mainly product labeling, strength/package matching, and procurement code mapping, not just active ingredient equivalence.

Key risks in substitution

• Different concentration or total iodine delivery
• Different recommended volumes and administration instructions by labeling
• Different procurement NDC/product codes or national reimbursement codes

Key Takeaways

• Gastrografin sourcing is market-driven: procurement “suppliers” are usually wholesalers/distributors of record, not always the manufacturing brand owner.
• The most reliable ordering strategy is to match the exact active ingredients and product packaging/strength used in your tenders.
• Qualification should focus on GDP compliance, lot traceability, and pharmacovigilance documentation, given iodinated contrast supply variability.

FAQs

1) Can hospitals buy Gastrografin through any distributor, or only authorized channels?

Hospitals typically should source through tendered, authorized distributor channels that can provide GDP-compliant documentation and lot traceability required for pharmacovigilance.

2) Are Gastrografin equivalents interchangeable at the packaging and strength level?

Interchangeability depends on matching active ingredients, labeled indications, concentration, and packaging size. Tender codes usually require exact product match.

3) What documentation should a Gastrografin supplier provide at delivery?

Suppliers typically provide lot number, expiration date, documentation aligned with GDP requirements, and any required quality documents such as certificates of analysis where required by the destination healthcare system.

4) How do suppliers manage urgent demand spikes for iodinated contrast media like Gastrografin?

They rely on framework contract stock, distributor-managed inventory, and secondary emergency sourcing subject to regulatory and tender constraints.

5) What substitution disputes most often arise with diatrizoate contrast products?

Disputes most often arise from mismatched concentration, unit volume, labeling indications, or failure to match the exact procurement product code.

References

1. European Medicines Agency (EMA). Gastrografin (diatrizoate) product information and assessment documents (where applicable).
2. FDA. Orange Book and drug listing resources for iodinated contrast media (where applicable).
3. World Health Organization (WHO). GDP guidance and supply chain requirements for medicines (baseline principles relevant to contrast media distribution).