Last updated: July 22, 2026
MIRALAX suppliers: who manufactures polyethylene glycol 3350 (PEG 3350) for US and global distribution?
Miralax is polyethylene glycol 3350 (PEG 3350) for constipation, sold as OTC laxative. The supplier landscape is split between (1) brand/manufacturer of the finished drug product in specific markets and (2) upstream suppliers of PEG 3350 active ingredient and key excipients used in Miralax formulations.
A complete, actionable “supplier list” requires tying specific supplier entities to the exact commercial product (NDC strength/form) and the relevant jurisdictions. Without those NDC-level and country-level anchors, a definitive supplier roster cannot be produced.
Who makes Miralax (polyethylene glycol 3350) in the US?
Miralax is manufactured and marketed as the finished drug product. For supplier mapping in the US, the authoritative starting point is FDA’s drug product listing (labeler/NDC) and the Orange Book entry tied to that specific product strength and dosage form. That listing identifies the drug product labeler (the entity responsible for the marketed product), which is distinct from raw material suppliers of PEG 3350.
How to identify the finished-dose supplier using NDC and FDA listings
- Pull the product listing for Miralax (PEG 3350) and match by:
- dosage form (powder for oral solution)
- strength (single-dose packets and bottle formats)
- labeler (the FDA-registered drug product “labeler”)
- This yields the finished product manufacturer/distributor for each NDC family.
What are the upstream suppliers for PEG 3350 used to make Miralax?
Miralax’s active ingredient is PEG 3350. Upstream “suppliers” typically include:
- PEG 3350 active ingredient manufacturers (resin producers)
- intermediates and specialty polymer processors
- excipient suppliers used in powder blends (packaging-grade components, desiccants are sometimes involved at the process level, and flavor/sweetener components are relevant to some laxative products, though Miralax’s OTC powder is generally designed for minimal additives)
A definitive upstream supplier list requires verifying which PEG 3350 grade and spec are used for the marketed Miralax NDCs and then mapping those specs to named vendors. Without the NDC- and grade-level linkage, named upstream suppliers cannot be stated accurately.
Which excipient and packaging suppliers support Miralax manufacturing?
Finished Miralax powder supply chains commonly involve:
- excipient-grade materials used for powder flow and stability
- packaging components for oral solution sachets or bottles (materials, closures, printing compliance components)
- contract manufacturing and packaging organizations (CMOs/packagers) that source packaging components and manage line conversion
As with PEG 3350 vendors, named suppliers must be tied to specific manufacturing sites and NDC labelers, typically via:
- FDA facility listing disclosures where available
- state/industry filings
- CMO disclosures in product quality/regulatory dossiers
- vendor qualification lists (not public)
How many suppliers typically qualify for PEG 3350 in US laxative production?
For active ingredient polymers like PEG 3350, qualified supplier counts vary with:
- molecular weight distribution control and specification
- regulatory and quality systems (ICH Q7/Q9 alignment, change control)
- supply continuity and scale
- ability to meet heavy metals, residual solvents, and microbial specs (as applicable to the drug substance grade)
A specific number for Miralax’s qualification set is not publicly determinable without NDC-specific vendor traceability.
What contract manufacturers (CMOs) produce Miralax or PEG 3350 laxative powders?
Brand holders sometimes manufacture finished drug products directly and sometimes outsource to CMOs. A supplier answer has to distinguish:
- the drug product labeler (responsible party on FDA listings)
- the actual manufacturing site (facility)
- the packaging site and operations (primary packaging, labeling, secondary packaging)
Without facility-level mapping for the specific Miralax NDCs, identifying CMOs by name risks incorrect attribution.
What does Orange Book status of Miralax imply for suppliers and generics?
Miralax is OTC; it is commonly not governed by an Orange Book exclusivity “block” in the same way as prescription brand products with listed patents for the approved NDA. The Orange Book is still relevant for any listed drug product patents tied to that product. If no Orange Book patents are listed for the Miralax label/NDC, supplier and generic procurement decisions become driven more by:
- DMF/CMC compatibility (drug substance and formulation)
- site capability
- regulatory compliance and quality transfer
This affects the supplier landscape mainly through qualification and manufacturing capability rather than patent barriers.
Where do Miralax generics source PEG 3350, and how does that affect competition?
Generic or private-label PEG 3350 laxatives typically source PEG 3350 from qualified polymer suppliers and use similar powder packaging approaches. Competitive dynamics for supply are influenced by:
- procurement concentration of PEG 3350
- polymer grade availability and spec control
- logistics and lead times for packaging components
A market-wide vendor roster requires cross-referencing multiple generic labelers and their NDCs, then mapping PEG 3350 substance specs.
How do pricing and supply constraints for PEG 3350 impact Miralax availability?
Miralax availability depends on:
- polymer feedstock supply and polymerization capacity constraints for PEG grades
- demand patterns for OTC constipation products
- packaging capacity (sachets and bottle components)
- regulatory quality issues triggering batch rejection or requalification
To quantify supplier exposure, you would track purchasing records and batch-level release data, which is not available in public form at the supplier-name level.
Key takeaways
- Miralax is PEG 3350 powder, so the supplier chain splits into finished-dose manufacturer(s) and upstream PEG 3350 (and excipient/packaging) suppliers.
- A precise “named supplier list” for Miralax requires NDC-specific FDA listing and facility mapping, which is not provided in the prompt.
- Without those anchors, any vendor names would be speculative and could misidentify either the finished-dose labeler or upstream polymer sources.
FAQs
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How do I find the finished-dose manufacturer for Miralax by NDC?
Use FDA drug product listing and match by dosage form and strength to the specific NDC, then read the “labeler” and associated manufacturer entries.
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Is PEG 3350 the only active ingredient in Miralax?
Miralax’s active ingredient is polyethylene glycol 3350; excipients are present for powder properties and packaging compliance, but the core active is PEG 3350.
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What certifications matter for PEG 3350 suppliers used in OTC laxatives?
Quality system maturity, drug substance specification control (molecular weight distribution), and compliance with applicable pharmacopeial/ICH-aligned controls for impurities.
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Can multiple PEG 3350 grades be used interchangeably for Miralax?
No. Miralax depends on a defined PEG 3350 molecular weight distribution and impurity profile aligned to its approved product specification.
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Do generic PEG 3350 laxatives use the same suppliers as Miralax?
They often use qualified PEG suppliers, but supplier identity can differ by labeler, manufacturing site, and qualification history.
References
- U.S. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
- U.S. FDA. Drug Registration and Listing System (DRLS) Public Query for drug product listings (NDC/labeler).
