Suppliers and packagers for generic pharmaceutical drug: dextrose

dextrose

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
B Braun	DEXTROSE 10% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	019626	NDA	B. Braun Medical Inc.	0264-7387-50	4 CONTAINER in 1 CASE (0264-7387-50) / 2000 mL in 1 CONTAINER	2015-02-19
B Braun	DEXTROSE 10% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	019626	NDA	B. Braun Medical Inc.	0264-7510-00	12 CONTAINER in 1 CASE (0264-7510-00) / 1000 mL in 1 CONTAINER	1988-02-02
B Braun	DEXTROSE 10% IN PLASTIC CONTAINER	dextrose	INJECTABLE;INJECTION	019626	NDA	B. Braun Medical Inc.	0264-7510-10	24 CONTAINER in 1 CASE (0264-7510-10) / 500 mL in 1 CONTAINER	1988-02-02

Pharmaceutical Dextrose Suppliers: Who Sells Dextrose API and Injection-Grade Dextrose Globally

Last updated: May 25, 2026

Executive summary: Dextrose supply chains split into (1) glucose/dextrose monohydrate made from corn or other starch feedstocks, (2) pharmaceutical-grade dextrose monohydrate/dextrose anhydrous used in IV solutions and tablets, and (3) finished sterile dextrose injections prepared under GMP. In practice, buyers source either from large commodity glucose producers that qualify into pharma, or from sterile injectables manufacturers with FDA/EMA-quality documentation and validated sourcing of pharmaceutical dextrose. Key suppliers span Archer Daniels Midland (ADM), Cargill, Tate & Lyle, Roquette, Gulshan Polyols (for dextrose monohydrate supply into pharma channels in some markets), and regional sterile injectables players that purchase USP-grade dextrose.

What companies supply pharmaceutical-grade dextrose (USP/pharma dextrose monohydrate and anhydrous)?

Short answer: Buyers typically purchase from large glucose/dextrose producers (USP/EP compliance) and from sterile injectables manufacturers that incorporate that dextrose into IV solutions under GMP.

Commodity dextrose monohydrate suppliers feeding pharma channels

These companies sit upstream in starch conversion and produce dextrose monohydrate and related glucose solids. They are common sources for USP dextrose ingredients, depending on buyer qualification, regulatory dossier readiness, and lot traceability.

• ADM (Archer Daniels Midland): global glucose and dextrose production scale; supplies industrial and food/pharma-qualified channels in many regions.
• Cargill: glucose solids including dextrose monohydrate; established pharmaceutical-grade supply programs via customer qualification.
• Tate & Lyle: corn-based glucose systems and dextrose products; supplies into regulated markets.
• Roquette: starch conversion and dextrose monohydrate; pharma focus via customer dossiers and quality systems.
• Gulshan Polyols: dextrose monohydrate production and distribution into international markets, including pharma pathways where supported by documentation.

Finished sterile dextrose injection suppliers (IV dextrose solutions)

For IV therapy, buyers often contract sterile injectables manufacturers rather than buying API and formulating sterile solutions. The manufacturer provides sterile processing, container-closure control, and batch release testing.

• ICU/sterile injectables suppliers vary by country and product (D5W, dextrose in saline, concentrated dextrose). The supplier set is driven by national tender structures and FDA/EMA product registrations.

Which suppliers sell dextrose for IV solutions (D5W, D10W, dextrose + saline) in the US?

Short answer: In the US, D5W and D10W are typically sourced from FDA-registered sterile injectables manufacturers. Dextrose API is commonly sourced from qualified glucose/dextrose ingredient producers upstream, then compounded and sterilized by the IV manufacturer.

What to look for when selecting an IV dextrose supplier

• NDA/ANDA status is less relevant for established sterile generics and more relevant for specific package presentations.
• FDA listing on the drug label for the finished product and the quality system alignment for GMP sterile manufacturing.
• Confirm USP-grade dextrose input and documented compendial conformity in the Drug Substance (DS) specification.

Common buyer-facing categories

• Finished “dextrose injection” manufacturers (sterile compounding plants with US release).
• Multi-dose and single-dose packaging suppliers (vial/bag formats).
• Contract sterile manufacturers (CMOs) that can fill dextrose solutions if a buyer holds formulation and regulatory rights.

What suppliers provide dextrose monohydrate for tablets, oral powders, and excipient use?

Short answer: Oral and excipient dextrose use is usually supplied by the same upstream dextrose monohydrate producers that support USP/EP/Ph. Eur compendial grades, plus specialized ingredient distributors that manage regulatory documentation.

Ingredient distributor vs. producer

• Producer supply: direct qualification for GMP and compendial compliance.
• Distributor supply: often faster access to inventories but requires buyers to audit the producer’s documentation chain and batch traceability.

Are Archer Daniels Midland, Cargill, Tate & Lyle, and Roquette major pharmaceutical dextrose sources?

Short answer: Yes for upstream dextrose solids. These firms supply glucose and dextrose products used in regulated markets, subject to buyer qualification and compendial grade documentation.

Typical buyer qualification signals

• USP/EP-ready specifications (purity, optical rotation, reducing sugars, sulfated ash, water content).
• GMP manufacturing and quality system audit outcomes.
• Export documentation aligned to destination market requirements (DMF/CEP pathways when applicable).

Which dextrose suppliers are strongest outside the US (EU, UK, Middle East, India)?

Short answer: EU/UK regulated supply depends on local sterile injectables availability, while the ingredient market commonly draws from European and global corn/glucose producers plus Asia-based dextrose monohydrate producers with export documentation.

Asia-based supplier role

• India-origin dextrose monohydrate producers such as Gulshan Polyols often compete on cost and scale, with pharma eligibility determined by buyer audits and compliance package completeness.

Middle East import patterns

• Often route through distributors with established dossier and QA systems for pharmaceutical excipients and sterile supplies.

What dextrose manufacturing inputs drive supply (corn starch, other starches) and pricing?

Short answer: Dextrose is starch-derived. Supply depends on (1) global corn or alternative starch availability, (2) conversion capacity for glucose and dextrose solids, and (3) energy and freight conditions that affect conversion and export economics.

Feedstock sensitivity

• Corn-derived dextrose is tied to corn markets and ethanol-adjacent dynamics.
• Alternative starch sources (where used) shift sourcing risk but do not remove the feedstock input linkage.

Capacity and turnaround

• Dextrose is relatively commoditized, so supplier lead times depend on seasonal production schedules and pharma-grade inventory buffers.

What supplier risks matter for dextrose (quality, compendial compliance, sterile contamination)?

Short answer: Dextrose is high-volume but not “low-risk” for IV use because sterile processes and DS specifications impact patient safety.

Quality risk checklist

• DS compliance to USP/EP with stable identity and impurity profile.
• Batch-to-batch impurity control, including reducing sugar profiles and residual salts.
• Traceability from starch feedstock to dextrose monohydrate lots used for sterile compounding.

Sterile risk for IV products

• Container closure integrity, endotoxin testing, sterility assurance level controls.
• Cold chain considerations are usually less central for dextrose solutions than for biologics, but storage and bag/vial stability matter.

How do you compare dextrose API suppliers vs finished sterile dextrose injection suppliers?

Short answer: API suppliers compete on compendial dextrose quality, documentation, and supply reliability. Finished product suppliers compete on sterile manufacturing controls, regulatory product listing, and packaging format availability.

Comparison table: API vs finished sterile

Sourcing choice	What you buy	Main qualification focus	Key supplier set
API dextrose monohydrate	Dextrose solids (USP/EP grade)	DS specs, QC testing, GMP, traceability	ADM, Cargill, Tate & Lyle, Roquette, other dextrose monohydrate producers
Finished IV dextrose	Sterile dextrose injection bags/vials	Sterile GMP, endotoxin/sterility, labeling and release	Country-specific FDA/EMA sterile injectables manufacturers and CMOs
Excipient/oral dextrose	Dextrose monohydrate for oral use	Compendial grade and regulatory documentation	Upstream producers plus ingredient distributors

What patent landscape affects dextrose suppliers?

Short answer: Dextrose is a commodity active ingredient. Patent estates are generally not a barrier in the way they are for novel drugs. Competitive constraints are typically regulatory documentation, GMP audits, and sterile manufacturing capacity for finished products, not active-ingredient composition patents.

Practical IP constraints

• If a supplier claims a specific manufacturing method or impurity reduction process, those process patents can affect qualification in rare cases.
• Most buyers treat dextrose as low-IP and focus on regulatory and quality pathways.

Commercial outlook: what determines which dextrose suppliers win?

Short answer: Award decisions for dextrose are driven by (1) availability and lead time, (2) ability to meet US/EU labeling and compendial requirements, (3) documentation completeness for pharma/sterile programs, and (4) price discipline from commodity-scale producers.

Buying criteria that correlate with supplier wins

• Ability to supply multiple forms: dextrose monohydrate solids and/or finished dextrose injection presentations.
• Audit outcomes and batch documentation turnarounds.
• Contract terms tied to GMP supply assurance and change control.

Key Takeaways

• Dextrose supply splits into upstream glucose/dextrose producers (ingredient) and sterile injectables manufacturers (finished IV solutions).
• Major upstream players that commonly appear in pharma-qualified dextrose supply chains include ADM, Cargill, Tate & Lyle, and Roquette, with other producers such as Gulshan Polyols contributing in global markets where documentation supports pharma use.
• For IV therapy, the practical supplier decision is often the finished sterile product manufacturer because sterile manufacturing controls dominate risk.
• Competitive pressure is commodity-driven; supplier selection hinges on GMP qualification, compendial conformity, traceability, and delivery reliability rather than “patent protection” dynamics.

FAQs

1) Who manufactures USP dextrose monohydrate?

Upstream starch-conversion producers with GMP and compendial capabilities commonly supply USP dextrose monohydrate into pharma channels, including ADM, Cargill, Tate & Lyle, and Roquette, subject to buyer qualification and documentation.

2) Can hospitals source dextrose API directly instead of buying D5W/D10W?

Hospitals can source dextrose solids as ingredients, but most IV delivery is done by purchasing finished sterile dextrose injection products or using pharmacy compounding under local regulations and sterility standards.

3) Which suppliers are best for D5W and D10W in the US?

Best-fit suppliers are FDA-registered sterile dextrose injection manufacturers offering specific package formats and strengths; the qualifying supplier set is determined by product availability and contracting rather than a single universal dextrose API producer.

4) Are there alternative sources to corn-based dextrose?

Yes. Dextrose can be produced from various starch feedstocks depending on regional processing, but corn remains dominant; feedstock choice affects supply and pricing.

5) What matters most in dextrose quality for IV use?

Sterile manufacturing controls for the finished solution plus DS compendial compliance and traceability (lot identity, impurity profile, and endotoxin/sterility release testing) matter most.

References

1. Archer Daniels Midland Company (ADM). Company information and glucose/dextrose product operations.
2. Cargill. Glucose and dextrose manufacturing and product information.
3. Tate & Lyle. Glucose and dextrose product information.
4. Roquette. Starch conversion and dextrose product information.
5. Gulshan Polyols. Dextrose monohydrate product and manufacturing information.