Suppliers and packagers for MANNITOL 15%

MANNITOL 15%

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Hospira	MANNITOL 15%	mannitol	INJECTABLE;INJECTION	016269	NDA	Henry Schein, Inc.	0404-9905-50	1 VIAL, SINGLE-DOSE in 1 BAG (0404-9905-50) / 50 mL in 1 VIAL, SINGLE-DOSE	2022-01-12
Hospira	MANNITOL 15%	mannitol	INJECTABLE;INJECTION	016269	NDA	Hospira, Inc.	0409-4031-01	25 VIAL, SINGLE-DOSE in 1 TRAY (0409-4031-01) / 50 mL in 1 VIAL, SINGLE-DOSE (0409-4031-16)	2004-11-30
Hospira	MANNITOL 15%	mannitol	INJECTABLE;INJECTION	016269	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1468-1	50 mL in 1 VIAL, SINGLE-DOSE (51662-1468-1)	2019-12-13
Hospira	MANNITOL 15%	mannitol	INJECTABLE;INJECTION	016269	NDA	HF Acquisition Co LLC, DBA HealthFirst	51662-1468-3	25 POUCH in 1 CASE (51662-1468-3) / 1 VIAL, SINGLE-DOSE in 1 POUCH (51662-1468-2) / 50 mL in 1 VIAL, SINGLE-DOSE	2019-12-13

Suppliers and packagers for MANNITOL 15%

Last updated: June 14, 2026

Mannitol 15% (150 mg/mL) Suppliers: Who Manufactures the Infusion Product and What to Source for US/Global Procurement

Mannitol 15% injection (commonly 150 mg/mL), an osmotic diuretic used for intracranial pressure reduction and prevention/treatment of acute renal failure in selected settings, is supplied globally as sterile, parenteral-grade mannitol solution. In the US, procurement and IP exposure are typically governed by FDA listing (Orange Book if applicable) and the manufacturer’s NDA/ANDA portfolio; in many markets, the product is sourced from multiple sterile injectables plants under DMFs and finished-product registrations.

High-confidence sourcing targets for “Mannitol 15%” purchasing are the finished-product manufacturers listed on FDA and major international regulatory catalogs, plus distributors with direct chilled/ambient logistics for sterile injectables. Exact supplier lists vary by country, vial size (e.g., 100 mL, 250 mL, 500 mL), container closure, and whether the source is branded vs. generic.

---

Which companies supply mannitol 15% injection (150 mg/mL) in the US?

US finished-product supply is usually split across generic sterile injectables manufacturers and brand-originators. For procurement-grade accuracy, buyers should map:

1. NDC level manufacturer/labeler (finished-product)
2. Plant location (sterile manufacturing site)
3. Pack configuration (bag vs vial, volume)
4. DMF coverage (if importing API or using contract sterile fill-finish)

What to request from each supplier

• Sterile injectables compliance package (sterility assurance, bioburden control, endotoxin)
• Certificate of Analysis (CoA) format and test panel
• Stability data for 15% mannitol under the labeled storage conditions
• Container-closure compatibility statement (for leachables/extractables)
• Source chain transparency: API from which mannitol producer and where it is crystallized/processed

---

What suppliers provide mannitol API for making 15% injection?

If the sourcing scope includes upstream supply (API rather than finished product), buyers typically qualify:

• Mannitol (USP/EP/JP grade) producers
• API crystallization and refining plants
• Sterile-ready solution formulation capability (dilution, filtration, final filling into sterile containers)

Common API supply pathways

• Direct API import for in-house sterile fill-finish
• Contract manufacturing for solution compounding and aseptic filling
• Hybrid: API purchased, sterile fill-finish by CDMO

---

How do vial vs bag formats change supplier eligibility for mannitol 15%?

Mannitol 15% is sold in multiple package formats. Supplier qualification depends on:

• Container type: plastic infusion bags vs glass vials
• Closure system: rubber stoppers, seals, and overlay films
• Leak testing method and batch-level integrity testing
• Compatibility with infusion sets (particulate control and adsorption risk)

Procurement implication

A supplier that can provide the drug substance does not automatically have a validated aseptic process for every packaging format.

---

Which raw material specs matter for mannitol 15% injection procurement?

Sterile injectable acceptance centers on specification compliance rather than just content strength.

Spec items typically critical

• Mannitol assay and identity (USP/EP criteria)
• Residual solvents (for upstream processing)
• Optical rotation and crystallinity behavior (grade-dependent)
• Sodium, chloride, and sulfate limits (impurity controls)
• Endotoxin and sterility (finished product)
• pH and osmolality targets for the 15% formulation

---

What manufacturing standards qualify suppliers of mannitol 15% for hospital procurement?

Buyers generally require evidence of:

• Aseptic processing controls
• Environmental monitoring and cleanroom classification
• Media fill results
• Sterility assurance level target and validation documentation
• Batch record traceability tied to NDC/lot release

Documentation hospitals and wholesalers ask for

• GMP compliance statements
• Batch release and sterility/endotoxin CoA
• Serialization or track-and-trace records (where required)
• Recall history and CAPA summaries on request

---

What is the typical regulatory status for mannitol 15% injection in the US (FDA listing/Orange Book)?

Procurement planning uses FDA systems:

• NDC Directory for labeled strength, dosage form, and manufacturer
• Orange Book when there are listed patents tied to an approved product
• CDER drug listings for labeling and approval history

Why this matters for supplier selection

If multiple suppliers sell the same dosage strength, the buyer still needs to match:

• Labeling indications
• Container and administration instructions
• Lot availability and continuity of supply (critical for sterile injectables)

---

Which generics and private-label brands are sold as mannitol 15% injection?

In many countries, mannitol 15% is available as:

• Generic sterile injectables
• Hospital supply distributor private label
• Brand-origin products (where historically introduced)

How to build a competitor-supply matrix

At minimum, map:

• NDC (or local registration number)
• volume per unit (100 mL, 250 mL, etc.)
• labeler and manufacturer
• shelf life and storage conditions
• backorder frequency (from wholesaler inventory reports)

---

When do procurement supply risks increase for mannitol 15% injection (shortages/allocations)?

Risk spikes usually track:

• Sterile fill-finish capacity constraints at major plants
• API price spikes or supply interruptions
• Regulatory actions impacting specific lots (sterility/endotoxin excursions)
• Transportation disruptions for refrigerated or humidity-sensitive packaging components (if applicable)

Mitigation steps buyers use

• Dual-source qualification (at least 2 finished-product manufacturers)
• Buffer inventory at health system level for 30 to 90 days
• Include alternate pack sizes to preserve treatment continuity

---

How do you qualify a new supplier for mannitol 15% injection (checklist for RFP)?

Qualification requirements

• GMP audit readiness (remote documents first, then on-site if needed)
• Lot-by-lot CoA review protocol
• Analytical method acceptance (assay, impurities, endotoxin, sterility)
• Stability program: confirm labeled shelf life and after-opening guidance (if stated)
• Packaging verification: leak integrity, particulates, and container compatibility

Commercial terms to lock

• Lead time for sterile lots
• Minimum order quantities by volume and closure format
• Allocation policy during market stress
• Quality agreement template and change control notification SLAs

---

Global supply: which regions tend to dominate mannitol 15% injection manufacturing?

Manufacturing concentration for sterile injectables typically clusters in:

• EU and UK sterile injectables hubs
• US sterile injectables capacity
• India and China for generic sterile solutions in many export channels

Procurement implication

Global sourcing often requires:

• Importer-of-record responsibility clarity
• Local labeling compliance
• Cold chain requirements only when specified (mannitol 15% is often ambient controlled unless otherwise labeled)

---

Key Takeaways

• Mannitol 15% injection is supplied through multiple sterile injectables manufacturers; best procurement accuracy comes from mapping NDC/registration + plant + packaging format.
• Supplier qualification should prioritize sterility/endotoxin release performance, GMP evidence, stability, and container-closure compatibility over just strength and price.
• Supply risk is most sensitive to aseptic fill-finish capacity and lot-level sterility assurance outcomes, so dual-source planning reduces downtime.

---

FAQs

1) What packaging formats are used for mannitol 15% injection (150 mg/mL)?
Common formats include infusion bags and vials; exact selection depends on local availability and hospital workflow.

2) Does mannitol 15% require special storage conditions?
Storage is defined by the labeled product; procurement should follow the supplier’s product label and stability program.

3) Can hospital pharmacies substitute different volume presentations of mannitol 15%?
Substitution is typically allowed only when the formulation, container type, and labeling match the clinical protocol.

4) What quality tests matter most for sterile mannitol 15% injection lots?
Sterility, endotoxin, assay/identity, impurity profile, and container integrity/leak testing are core acceptance items.

5) How should buyers manage shortages for mannitol 15% injection?
Use qualified dual sources, maintain a buffer inventory, and predefine pack-size alternatives to prevent treatment interruption.

---

References (APA)

1. FDA. (n.d.). NDC Directory (Drug Products). U.S. Food and Drug Administration.
2. FDA. (n.d.). Drugs@FDA. U.S. Food and Drug Administration.
3. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.