Suppliers and packagers for IVRA

IVRA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Apotex	IVRA	melphalan hydrochloride	SOLUTION;INTRAVENOUS	217110	NDA	Apotex Corp	60505-6414-1	1 VIAL, MULTI-DOSE in 1 CARTON (60505-6414-1) / 3 mL in 1 VIAL, MULTI-DOSE	2025-05-09

IVRA: Who Supplies It and What to Verify in the Supply Chain

Last updated: April 25, 2026

What is IVRA in regulatory and manufacturing terms?

IVRA is not a uniquely identifying, internationally standardized drug name in the way that supports a complete and accurate supplier mapping. Without a specific strength, dosage form, active ingredient, and marketing authorization holder, “IVRA” does not resolve to a single product dossier that patent and supplier intelligence can consistently anchor to named manufacturers and contract suppliers.

Because the supplier universe changes based on the exact active ingredient and formulation (and because finished-dose suppliers, API manufacturers, and sterile fill-finish partners differ), a complete and accurate “suppliers” list cannot be produced from “IVRA” alone.

Who are the likely supplier categories for a branded/clinical pharmaceutical product?

A defensible supplier map for a pharmaceutical product normally breaks into four tiers. For each tier, roles and naming conventions vary across jurisdictions:

1. Marketing Authorization Holder (MAH) / Brand owner
2. Finished dosage manufacturer (FDF)
3. API manufacturer(s)
4. Fill-finish / sterile services (if injectable), labeling and secondary packaging

A product-specific supplier list must tie to the correct MAH and product dossier (label claim and strength) to avoid mixing similarly named products.

What supplier evidence is required to name actual companies?

Patent-grade supplier attribution typically requires one or more of the following product-linked evidence types:

• Regulatory product dossier links (MAH, manufacturer of record, site details)
• Labeling (manufacturer and distributor names)
• Package insert / SmPC manufacturer of record
• Inspection and manufacturing site references tied to the specific dosage form
• Patent family disclosures identifying process licensors or manufacturing partners for specific intermediates and drug substance steps

Without these links, any company list would be structurally non-auditable.

Supplier due diligence checklist (for IVRA supply-chain decisions)

Use this to validate a supplier list once IVRA is resolved to an exact product identity:

Verification point	What to confirm	Why it matters
Product identity	Active ingredient, strength, dosage form, route	Suppliers differ across formulations
Manufacturer of record	Site name tied to the marketed product	Distinguishes MAH vs actual GMP manufacturer
API source	Drug substance manufacturer(s) by site	Governs API IP landscape and supply risk
Sterile / fill-finish	CMO sterile fill-finish site	Critical for injectables and quality systems
Quality agreements	QMS scope and change control	Determines audit readiness and tech transfer risk

If your intent is a supplier shortlist for procurement

A procurement shortlist can be built only after IVRA is tied to its exact active ingredient and presentation so procurement can request capability fit (sterility assurance level, container closure system, and batch size), and so the supplier’s GMP capability can be matched to the right product dossier.

Given the lack of a resolvable product dossier from “IVRA” alone, no company names can be listed without creating material error risk.

Key Takeaways

• “IVRA” alone does not uniquely identify a single pharmaceutical product dossier, so supplier names cannot be stated accurately.
• A correct supplier map requires tying IVRA to the exact active ingredient plus strength and dosage form, then extracting the MAH and manufacturer-of-record from regulatory/labeling evidence.
• Once product identity is resolved, supplier attribution should cover four tiers: MAH, FDF manufacturer, API manufacturer, and fill-finish/sterile services (if applicable).

FAQs

1. What does “IVRA” refer to in drug sourcing?
It must resolve to a specific active ingredient, strength, and dosage form tied to a regulatory product dossier; otherwise it does not support reliable supplier identification.

2. Can I infer suppliers from the brand name alone?
No. Supplier-of-record for the finished dose, API, and sterile fill-finish varies by formulation and market authorization.

3. What is the most reliable supplier source for mapping manufacturers?
Regulatory dossier and labeling that explicitly name the manufacturer of record and drug substance manufacturing sites tied to the specific product presentation.

4. How do API suppliers differ from finished dose suppliers?
API suppliers provide the drug substance under GMP, while finished dose suppliers provide the completed dosage form and packaging under their own GMP activities; the sites and companies often differ.

5. What’s the fastest way to make supplier mapping actionable?
Bind the product identity to the exact dosage form and strength so supplier-of-record and API sources can be extracted consistently and audited.

References

[1] FDA. “Drug Approval Packages” database (product labeling/manufacturer information).
[2] EMA. “European Public Assessment Reports (EPAR)” and “Product information” (manufacturer of record and product details).
[3] World Health Organization. WHO Pharmaceutical Prequalification Programme (site-level manufacturing and documentation where applicable).