OSMITROL 5% IN WATER: Pharmaceutical manufacturers, suppliers, and packagers

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Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Baxter Hlthcare	OSMITROL 5% IN WATER	mannitol	INJECTABLE;INJECTION	013684	NDA	Baxter Healthcare Company	0338-0353-03	500 mL in 1 BAG (0338-0353-03)	1964-06-08
Baxter Hlthcare	OSMITROL 5% IN WATER	mannitol	INJECTABLE;INJECTION	013684	NDA	Baxter Healthcare Company	0338-0357-02	250 mL in 1 BAG (0338-0357-02)	1964-06-08
Baxter Hlthcare	OSMITROL 5% IN WATER	mannitol	INJECTABLE;INJECTION	013684	NDA	Baxter Healthcare Company	0338-0357-03	500 mL in 1 BAG (0338-0357-03)	1964-06-08
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: June 4, 2026

OSMITROL 5% IN WATER Suppliers: Who Makes the 5% Osmolality-Adjusted Solution?

OSMITROL 5% IN WATER is a branded, ready-to-use pharmaceutical solution product. Supplier identification depends on the specific market (country), pack size, and labeling (Rx vs OTC) because the manufacturer or releaser can differ by geography and distribution channel.

What companies supply OSMITROL 5% IN WATER in the US?

OSMITROL 5% IN WATER is not uniquely tied to a single public-facing supplier without the country-specific product label details (manufacturer of record and labeler). Without those label identifiers, “suppliers” can mean different things:

manufacturer of the solution (site producing the bulk)
labeler/marketing authorization holder
national distributor/releaser

Who is the manufacturer of OSMITROL 5% IN WATER by labeler/marketing authorization holder?

To determine the manufacturer, the authoritative source is the product’s label and the regulator listing for that specific dosage form and strength (“in water” and 5%). For US sourcing, the Orange Book is the first place to check when the product is an FDA-approved drug with listed patents; for non-patented or non-Orange-Book products, FDA drug listing still indicates the labeler, though it does not always expose the actual manufacturing site.

Are OSMITROL 5% IN WATER suppliers the same across EU and UK?

Europe and the UK typically separate:

marketing authorization holder (MAH)
manufacturer(s) listed on the product information
batch release site (QPPV-related arrangements can vary)

Without country-specific labeling, cross-jurisdiction supplier mapping is unreliable.

Which wholesalers distribute OSMITROL 5% IN WATER?

Wholesaler availability is driven by national tendering and distribution contracts. In most markets, branded liquid solutions are carried by major pharmaceutical distributors, but the exact product listing varies by SKU and NDC/pack.

What ingredients define OSMITROL 5% IN WATER and how does that affect sourcing?

The key sourcing point for “in water” products is whether the 5% refers to:

the active ingredient concentration
a specific solute concentration (commonly a therapeutic osmotic agent)

Supplier sets tighten if OSMITROL’s active is a widely used, standardized API with multiple manufacturers versus a specialized excipient system or sterile compounded ingredient. For commercial sourcing, regulatory drug substance listing and GMP supply chain visibility often determine which firms can qualify as contract manufacturers or re-packers.

Does “5% in water” imply sterile, infusion-grade manufacture?

If the product is intended for clinical administration, it typically requires sterile manufacturing controls and specific batch release testing. That narrows the pool to contract sterile-liquid manufacturers with demonstrated sterile compliance.

Is OSMITROL 5% IN WATER compounded or commercially manufactured?

Commercial products are manufactured at licensed sites and released under batch controls. Compounded products are made by outsourcing facilities and are often not identical in supply behavior.

How many suppliers exist for OSMITROL 5% IN WATER and what are the likely roles?

In most markets, the supply chain for a branded solution generally includes:

1 primary manufacturer (or a small number of manufacturing sites)
1 or more labelers/MAHs
multiple distributors and relabelers

Supplier counts change by geography and whether the product is distributed through hospitals, mail-order, or retail channels.

What is the typical supplier structure for sterile liquid solution products?

Primary API and excipient sourcing is consolidated early.
Sterile filling and packaging is done by specialized sterile liquid contractors or by the brand’s own sites.
Distribution is managed by wholesalers and hospital GPO supply channels.

What patent and regulatory status affects who can supply OSMITROL 5% IN WATER?

If OSMITROL 5% IN WATER is protected by exclusivity, formulation IP, or limited manufacturing authorizations, it can constrain generic or alternative sourcing. If it is off-patent, supply may broaden to additional labelers and manufacturers.

Is OSMITROL 5% IN WATER listed on the Orange Book?

If the product is listed in FDA’s Orange Book, it provides a structured view of market exclusivity and patent coverage that can indicate which entities are positioned to supply authorized generic versions or AB-rated products.

Is it FDA-listed only as a drug (labeler information) without Orange Book patents?

Many solution products are listed as drugs but not covered by Orange Book patents. In those cases, supplier identification is driven by FDA drug product listing and labeler/manufacturer fields rather than patent tables.

What generic entry risks exist for OSMITROL 5% IN WATER?

The main entry risks are not patent-only. They are also:

sterile manufacturing capacity constraints
stability and container-closure system requirements for liquids
regulatory classification and labeling expectations

Can a different manufacturer supply the same OSMITROL 5% IN WATER SKU?

Yes if the product is a simple reformulation or if regulatory pathways allow. No if it is tightly constrained by manufacturing method validation, sterility assurance, or data exclusivity tied to the specific product.

Key Takeaways

Supplier identification for OSMITROL 5% IN WATER requires the country-specific labeler/manufacturer of record and product listing identifiers.
Supply chains for sterile liquid solutions typically split into manufacturer, labeler/MAH, and distributors.
Patent and FDA listing status influence whether additional labelers and generic-like supplies can enter.

FAQs

How do I identify the manufacturer of OSMITROL 5% IN WATER from the product label?
Use the “Manufacturer” or “Distributed by” fields and match them to the regulator’s drug listing for the same strength and dosage form.
Does OSMITROL 5% IN WATER require sterile GMP manufacturing?
If intended for parenteral or clinical administration, the product is typically manufactured as sterile solution with validated sterile controls.
Are wholesalers the same supplier as the product manufacturer?
No. Wholesalers distribute. The manufacturer produces and releases batches.
Can multiple sites manufacture OSMITROL 5% IN WATER?
Yes, but only those approved and listed for the product can supply compliant batches for the labeled SKU.
What documentation best supports supplier qualification for procurement?
Certificate of Analysis (CoA), manufacturer of record documentation, GMP status, and batch release information tied to the specific SKU.

References

No sources were provided in the request, and no product label, country, NDC/identifier, or regulatory listing record was provided to cite.

Suppliers and packagers for OSMITROL 5% IN WATER