VENOFER: Pharmaceutical manufacturers, suppliers, and distributors

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Am Regent	VENOFER	iron sucrose	INJECTABLE;INTRAVENOUS	021135	NDA	American Regent, Inc.	0517-2310-05	5 VIAL, SINGLE-DOSE in 1 BOX (0517-2310-05) / 10 mL in 1 VIAL, SINGLE-DOSE (0517-2310-01)	2007-06-12
Am Regent	VENOFER	iron sucrose	INJECTABLE;INTRAVENOUS	021135	NDA	American Regent, Inc.	0517-2325-10	10 VIAL, SINGLE-DOSE in 1 BOX (0517-2325-10) / 2.5 mL in 1 VIAL, SINGLE-DOSE (0517-2325-01)	2011-01-27
Am Regent	VENOFER	iron sucrose	INJECTABLE;INTRAVENOUS	021135	NDA	American Regent, Inc.	0517-2340-99	10 VIAL, SINGLE-DOSE in 1 CARTON (0517-2340-99) / 5 mL in 1 VIAL, SINGLE-DOSE	2014-07-14
Am Regent	VENOFER	iron sucrose	INJECTABLE;INTRAVENOUS	021135	NDA	American Regent, Inc.	0517-2340-01	1 VIAL, SINGLE-DOSE in 1 BOX (0517-2340-01) / 5 mL in 1 VIAL, SINGLE-DOSE	2014-07-14
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: May 27, 2026

Suppliers for VENOFER (iron sucrose): key manufacturers, contract-fill bottlers, and supply-chain risk points

Executive summary: VENOFER (iron sucrose injection) is supplied by its marketing authorization holder in each market and sourced through a small set of industrial upstream vendors for iron sucrose drug substance and parenteral manufacturing. In the US, the Orange Book lists VENOFER products and associated applicants/holders, which is the fastest way to identify the legal product supplier and the associated manufacturing network. For procurement planning, the highest practical risk points are (1) batch release and parametric controls for parenteral sterile manufacturing, (2) drug-substance feedstock and dewatering capacity for iron sucrose, and (3) availability of finished drug product tied to specific NDC and strength presentations.

What follows focuses on supplier identification based on regulator-linked product entries (Orange Book/FDA label supply chain links) and common parenteral manufacturing realities for iron sucrose products.

Who supplies VENOFER (iron sucrose injection) in the US and what companies are listed on the FDA label?

Primary supplier (US commercial product): VENOFER is marketed in the US under the brand “VENOFER” and held on FDA product listings by the brand’s marketing authorization holder. For supplier diligence, the “applicant/holder” and “labeler” fields on FDA listings are used to map the responsible party for product release and labeling.

Procurement-ready supplier mapping (what to extract from FDA files):

Labeler / applicant / marketing authorization holder for each NDC (strength and pack size).
Manufacturer(s) listed under the FDA label “Manufactured for” / “Distributed by” language.
Drug substance manufacturer (often captured in CMC for ANDA/505(b)(2) or NDA manufacturing sections, but can be inferred from cross-referenced manufacturer names when the label names them).

Orange Book and regulatory listing basis:

The Orange Book is the canonical index for identifying the product “holder” and any listed patents tied to that specific drug product/NDC. Patent-holder identity often tracks the supplier/commercial owner of the branded product, but drug manufacturing can be executed by a contract sterile manufacturer.
For finished product procurement, the FDA label’s “Manufactured by/for” language is typically the decisive supplier designation.

What upstream suppliers make iron sucrose drug substance (the feedstock for VENOFER)?

Iron sucrose is a complex iron-carbohydrate complex manufactured via controlled precipitation/complexation and stringent purification to achieve a consistent particle size distribution and low free iron content suitable for IV use.

Upstream supplier categories that typically constrain iron sucrose supply:

Iron salts and base chemistry suppliers
- Supply of ferric iron precursors and process-grade reagents used in the complexation step.
- Quality controls include contaminants, residual metals, and reaction-grade consistency.
Specialty process and filtration systems vendors
- Industrial dewatering and filtration equipment vendors matter indirectly because batch throughput depends on process robustness and filter media availability.
Contract drug-substance manufacturers
- Many parenteral complex drugs rely on one or two industrial producers of the drug substance, then finished dosage manufacturing happens via a sterile fill-finish site.

Supplier diligence lens for iron sucrose:

Batch-to-batch consistency is governed by process parameters (complexation conditions, washing steps, and purification endpoints).
Sterility and endotoxin acceptance criteria apply at finished product stage, but upstream purity drives overall compliance margin.

Which companies perform VENOFER sterile fill-finish and batch release for each NDC?

Finished product for VENOFER is an IV parenteral formulation requiring:

A sterile manufacturing environment
Aseptic or terminal sterilization approach appropriate to the product
Tight control of particulate matter, pH, osmolality, and endotoxin

How to identify the real fill-finish supplier (actionable method):

Use the label “Manufactured by” and “Manufactured for” statements tied to each NDC.
Cross-check whether the listed “manufacturer” appears consistently across presentations (e.g., 50 mg/5 mL and 100 mg/10 mL) since sterile plants often run multiple strengths.

Key operational supply constraints in sterile IV drugs:

Availability of aseptic filling lines compatible with VENOFER container format.
Availability of qualified vials/closures and inspection capacity for visible particulate controls.
Release testing throughput (sterility, endotoxin, assay).

How does NDC-level packaging affect VENOFER supplier availability and lead times?

VENOFER comes in multiple strengths and presentations. In parenterals, supplier and lead-time risk is frequently NDC-specific rather than brand-wide.

Procurement implications:

If a specific NDC is manufactured in one sterile plant, that site’s capacity and downtime schedule controls product availability for that NDC.
Shortages can occur when one NDC production run is delayed even if other NDCs remain in stock.

What procurement teams should monitor for each NDC:

Finished product release calendars tied to fill-finish runs
Shelf-life release constraints after batch production
Supply continuity based on distribution route and warehouse allocation

What patent estate and legal status matters for VENOFER supply competition (generic and 505(b)(2))?

Patent protection affects who can manufacture and sell a competing iron sucrose product, but it does not usually prevent supply of the branded product itself. It does, however, influence whether alternative suppliers can enter at the product or formulation level.

Supplier competition pathways that can change supply:

Generic iron sucrose products may emerge if a competitor can launch with a permissible regulatory pathway.
505(b)(2) variants typically require bridge safety/efficacy data or reliance on published reference information.

Why this matters for “suppliers”:

A larger approved competitor set increases procurement leverage.
Patent and exclusivity terms often keep the supplier pool narrow, placing more weight on the branded manufacturer’s capacity planning.

Are there biosimilar risks for VENOFER supply?

No. VENOFER is a small-molecule iron-carbohydrate complex (not a biologic). Biosimilar frameworks do not apply.

What alternative iron sucrose brands or equivalent products affect VENOFER supplier leverage?

For procurement leverage, the key is whether there are:

Other FDA-approved iron sucrose injections with different NDCs and different manufacturing sites.
Other IV iron class alternatives that can substitute clinically, such as ferric carboxymaltose, ferric derisomaltose, ferric gluconate, ferumoxytol, depending on formulary and label contraindication nuances.

Supplier leverage logic:

Even if VENOFER faces a manufacturing bottleneck, equivalent IV iron products can reduce total demand pressure.
Substitution is constrained by clinical protocols and payor formularies.

What supply-chain and manufacturing barriers most often disrupt VENOFER availability?

For IV sterile drugs like VENOFER, typical barriers include:

Sterile fill-finish capacity constraints, including line downtime and vial inspection capacity
Drug-substance batch failures due to complexation endpoint variability or impurity excursions
Raw material shortages for iron salts and specialty reagents
Quality system events (deviations, CAPA extensions) that pause batch release
Container closure supply issues (vials and stoppers)

Most sensitive failure modes:

Particulate excursion risk and visible particle counts
Endotoxin or sterility test delays affecting release timing
pH adjustment or osmolality drift during formulation

Which distributors are typically involved in VENOFER distribution, and can they switch sources?

For a branded parenteral, distribution is usually handled by:

Authorized wholesalers and large distributors tied to the labeler’s distribution agreements
Specialty channels if immunology and oncology networks are relevant, which is less common for iron sucrose

Distribution flexibility:

Wholesalers typically distribute what the labeler supplies. If manufacturing is constrained, distributors cannot change the product supplier without FDA-recognized sourcing that matches the marketed NDC presentation.

How strong is the supplier concentration risk for VENOFER?

Concentration risk is usually high when:

The marketed product is produced in a small number of sterile sites
The drug substance comes from one or two industrial producers
Multiple strengths share the same bottleneck intermediate or finishing line

Supplier concentration indicators to check in due diligence:

Whether label-listed manufacturers show one dominant fill-finish site
Whether multiple NDCs map to the same manufacturer identity
Whether alternative NDCs exist with different manufacturing sites that can be used as substitutable procurement inventory

Key Takeaways

VENOFER supplier identification starts with regulator-linked product listings at the NDC level to find the labeler/applicant holder and the manufacturer(s) named on the FDA label.
The supply-chain risk concentrates in drug-substance consistency, sterile fill-finish capacity, and batch release testing rather than in biosimilar competition.
Procurement leverage improves when alternative IV iron products exist and when multiple VENOFER NDCs are manufactured at different sites; otherwise, lead times track the bottleneck site.

FAQs

How can I identify the manufacturer of a specific VENOFER NDC from public sources?
Check the FDA label language for “Manufactured by/for” and match to the NDC strength and package.
Does VENOFER have biosimilar entry risk like monoclonal antibodies?
No. VENOFER is not a biologic; biosimilar pathways do not apply.
What are the most common manufacturing steps that create supply bottlenecks for iron sucrose IV drugs?
Drug substance complexation/purification, sterile fill-finish line capacity, and batch release testing (sterility/endotoxin).
Can wholesalers switch VENOFER suppliers if one manufacturer is delayed?
Not typically without sourcing that matches the marketed NDC and label-relevant manufacturing authorization.
What substitution options reduce reliance on VENOFER procurement during shortages?
Other IV iron formulations approved for similar indications, subject to clinical protocol and formulary restrictions.

References (APA)

U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
U.S. Food and Drug Administration. Drug Label Information for VENOFER (iron sucrose). FDA.

Suppliers and packagers for VENOFER

VENOFER