Last Updated: May 2, 2026

Suppliers and packagers for generic pharmaceutical drug: POLYETHYLENE GLYCOL 3350


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POLYETHYLENE GLYCOL 3350

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Bayer Healthcare Llc MIRALAX polyethylene glycol 3350 FOR SOLUTION;ORAL 022015 NDA Bayer HealthCare LLC. 11523-4357-2 2 CARTON in 1 CARTON (11523-4357-2) / 20 PACKET in 1 CARTON / 17 g in 1 PACKET 2007-02-01
Bayer Healthcare Llc MIRALAX polyethylene glycol 3350 FOR SOLUTION;ORAL 022015 NDA Bayer HealthCare LLC. 11523-4357-3 2 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION (11523-4357-3) / 578 g in 1 BOTTLE, PLASTIC 2007-02-01
Bayer Healthcare Llc MIRALAX polyethylene glycol 3350 FOR SOLUTION;ORAL 022015 NDA Bayer HealthCare LLC. 11523-4357-5 24 PACKET in 1 CARTON (11523-4357-5) / 17 g in 1 PACKET 2007-02-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers for POLYETHYLENE GLYCOL 3350 (PEG 3350): Who Sells It and Under What Product Formats

Last updated: April 23, 2026

Which companies supply POLYETHYLENE GLYCOL 3350?

POLYETHYLENE GLYCOL 3350 (PEG 3350) is a commodity-grade excipient that multiple global chemical and excipient suppliers sell under multiple compendial and specification-aligned product lines. The supplier set below reflects companies that publicly market PEG 3350 for pharmaceutical and related industrial use, typically with product forms spanning granular powder and molten liquid.

Major global suppliers (pharma-excipient marketed)

Supplier Common product naming seen in catalogs Typical form(s)
BASF PEG 3350 (also marketed as macrogol 3350 in some markets) Solid (flakes/granules) and/or molten grade lines
Merck / MilliporeSigma PEG 3350 Solid
The Dow Chemical Company PEG 3350 Solid and/or liquid grades depending on catalog
Croda PEG 3350 / macrogol 3350 lines Solid and/or liquid formulations depending on grade
Kao Chemicals PEG / macrogol 3350 Solid
PPG? / Specialty excipient brands PEG 3350 branded excipient products Solid
Ashland PEG / macrogol excipient lines Solid and/or liquid grades

API/excipient distributors and re-packagers (often source multiple manufacturers)

Distributor What they typically do How PEG 3350 is sold
TCI Chemicals Chemical supplier and distributor Bulk solid; often multiple quality grades by use case
Fisher Scientific (Thermo) Distributor PEG 3350 in catalog packaging sizes
VWR / Avantor Distributor PEG 3350 with manufacturer-labeled COA for each lot
Spectrum Chemical Distributor Bulk and intermediate packaging

Note: PEG 3350 is widely sold by multiple brands; for compliance-sensitive use, buyers typically select the specific manufacturer grade aligned to pharmacopeias and documented specs through lot-level COAs.

What product specifications do buyers typically match for PEG 3350?

PEG 3350 is usually supplied with documentation aligned to pharmacopeial requirements for polyethylene glycols and macrogols. Buyers typically validate, per their regulatory framework (FDA/EMA/ICH or local), the following spec categories in the supplier’s CoA and/or product specification sheet:

  • Average molecular weight range consistent with 3350 (often reported as “PEG 3350” or “macrogol 3350”)
  • Hydroxyl value (indicative of polymer chain end functionality)
  • Viscosity or melting range (grade-dependent)
  • pH (for certain pharma uses)
  • Color (Hazen/APHA or similar) and transmittance
  • Water content
  • Peroxide and oxidizable impurities (oxidation stability indicators)
  • Residual catalyst/starting material limits (grade-dependent)
  • Residual heavy metals (typical elemental limits by pharmacopeia approach)
  • Microbial limits (where the supplier markets a pharma-excipient grade)
  • Specific pharmacopeial statements (e.g., USP, Ph. Eur., JP compatibility)

What are common packaging formats and grade types?

Suppliers generally offer PEG 3350 in one or more of these formats:

  • Solid grades (flakes, granules, or powders) for direct compounding or blending
  • Molten/temperature-managed grades (supplied as solid but melted/handled in-process)
  • Pharma-excipient grade vs industrial grade (buyers should select based on intended dosage form and regulatory pathway)

How to choose between suppliers (decision points that show up in real procurement)?

Procurement for PEG 3350 usually pivots on documented ability to deliver:

  • Pharmacopeial alignment (USP / EP / JP statements on the product spec)
  • Lot-to-lot repeatability: molecular weight distribution and viscosity/physical properties
  • Impurity profile (oxidizable substances, peroxides, heavy metals, residual ethylene glycol/1,4-dioxane controls where applicable)
  • Traceability: CoA issuance and batch labeling format
  • Supply reliability: multi-sourcing capability and lead-time history

Where PEG 3350 is used, and why supplier compliance matters

PEG 3350 is an excipient used in multiple therapeutic categories where purity, impurities, and microbial control can affect patient safety and product stability:

  • Oral laxatives (osmotic effect)
  • Tablet and capsule formulations (binder/disintegrant/processing aid)
  • Creams, gels, and suppositories (base/vehicle)
  • Fill/finish and analytical needs (processing aid and reference material in some workflows)

These use cases drive higher buyer scrutiny on CoA content and spec adherence.

Supplier landscape: what to expect by region

Global manufacturers and major excipient suppliers typically sell PEG 3350 via:

  • Direct sales to large pharma and excipient buyers (with controlled spec and documentation packages)
  • Distributor channels for smaller manufacturers and labs
  • Local warehousing with lot-level documentation support

The practical implication for sourcing is that most buyers should screen suppliers for both:

  • Documented pharmacopeial-grade product
  • Demonstrated COA/traceability workflow

Key Takeaways

  • PEG 3350 is supplied by major chemical and excipient vendors including BASF, Merck/MilliporeSigma, Dow, Croda, and Kao, with broad distribution also via TCI, Fisher Scientific, VWR/Avantor, and Spectrum.
  • Supplier selection typically depends on pharmacopeial alignment, impurity profile, batch traceability, and lot-to-lot repeatability.
  • Buyers should procure PEG 3350 using the specific grade/spec that matches their intended dosage form and regulatory requirements, not just the polymer name.

FAQs

1) Is PEG 3350 sold as “PEG 3350” and “macrogol 3350”?

Yes. PEG 3350 is commonly labeled as macrogol 3350 in many pharmaceutical contexts.

2) Can I source PEG 3350 through distributors instead of manufacturers?

Yes. Distributors typically sell PEG 3350 in packaged lots backed by supplier/manufacturer COAs, but the grade/spec should match the intended regulatory use.

3) What specs matter most for pharmaceutical PEG 3350?

The most scrutinized categories are molecular weight alignment, viscosity/melting behavior, impurity limits (including oxidation-related impurities), heavy metals, water content, and pharmacopeial compliance statements.

4) Are there pharma-grade and industrial-grade versions?

Yes. Suppliers often differentiate by grade based on microbial control, impurity limits, and documentation.

5) How do buyers validate PEG 3350 from a new supplier?

Buyers typically use the supplier’s product specification and lot COA, then confirm critical quality attributes relevant to their formulation (notably physical properties and impurity profile) for at least early incoming lots.

References

[1] BASF. Product information for polyethylene glycols/macrogols including PEG 3350 (company product listings).
[2] Merck. MilliporeSigma product listings for PEG 3350 (product page/specifications).
[3] Dow. Product listings for polyethylene glycol grades including PEG 3350.
[4] Croda. Excipient product listings covering macrogol/PEG 3350.
[5] Kao Chemicals. Polyethylene glycol/macrogol product listings including PEG 3350.
[6] TCI Chemicals. PEG 3350 product listings and specifications.
[7] Thermo Fisher Scientific. PEG 3350 product listing and documentation.
[8] Avantor (VWR). PEG 3350 product listing and COA availability.
[9] Spectrum Chemical. PEG 3350 catalog listing and grade information.

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