Suppliers and packagers for MIRALAX

MIRALAX

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
Bayer Healthcare Llc	MIRALAX	polyethylene glycol 3350	FOR SOLUTION;ORAL	022015	NDA	Bayer HealthCare LLC.	11523-7234-1	17 g in 1 PACKET (11523-7234-1)	2007-02-01
Bayer Healthcare Llc	MIRALAX	polyethylene glycol 3350	FOR SOLUTION;ORAL	022015	NDA	Bayer HealthCare LLC.	11523-7234-2	119 g in 1 BOTTLE, PLASTIC (11523-7234-2)	2007-02-01
Bayer Healthcare Llc	MIRALAX	polyethylene glycol 3350	FOR SOLUTION;ORAL	022015	NDA	Bayer HealthCare LLC.	11523-7234-3	238 g in 1 BOTTLE, PLASTIC (11523-7234-3)	2007-02-01

Suppliers and packagers for MIRALAX

Last updated: June 1, 2026

Miralax (polyethylene glycol 3350) Suppliers: Key Manufacturers, Contract Supply Risks, and Regulatory Footprint

Miralax is the brand name for polyethylene glycol 3350 (PEG 3350) oral laxative (typically 17 g per dose, powder for reconstitution). Whitefield/affiliate brand supply chains vary by market and package size, but the core manufacturing and sourcing question is consistent: PEG 3350 supply comes from bulk chemical and polymer suppliers and is then processed into the finished, packaged drug by the FDA-regulated drug manufacturer listed for Miralax on the FDA’s Orange Book.

This page maps the supplier ecosystem into three layers that matter for R&D, licensing, litigation, and contingency planning: (1) finished-dose drug manufacturers, (2) PEG 3350 API/bulk polymer suppliers, and (3) excipient and packaging component suppliers that can constrain manufacturing changes.

Who manufactures Miralax (PEG 3350) finished drug and supplies the US market?

Featured snippet answer: Finished Miralax drug supply in the US is controlled by the FDA-labeled NDA/ANDA holder and contract manufacturers listed for the product on the Orange Book. Those parties are the legally relevant “suppliers” for drug product manufacturing under cGMP.

What to pull from FDA Orange Book for “supplier” identification

For Miralax, the “supplier” you care about for regulatory and litigation is the party listed as the applicant and, where applicable, the manufacturers for drug product and drug substance.

Key Orange Book fields for supply-chain mapping:

• Application (NDA number for Miralax or equivalent listing)
• Dosage form (powder)
• Applicant (NDA holder)
• Manufacturer(s) (drug product manufacturing locations)
• Drug substance manufacturer (where listed)

Result: The authoritative supplier roster is Orange Book-based. Any “supplier” lists that do not map to Orange Book entries are commercial and often incomplete.

Typical contract-manufacturing model for OTC laxatives

Miralax is OTC and broadly distributed; US brands commonly use:

• A primary finished-dose manufacturer with FDA-registered sites
• Secondary capacity manufacturers for seasonal demand
• Third-party packaging suppliers for bottle, cap liners, child-resistant systems, and label printing

If a party is not in Orange Book manufacturer listings, it is typically a capacity supplier rather than the legally relevant manufacturer of record.

What excipients and packaging components constrain Miralax manufacturing?

Featured snippet answer: The main manufacturing constraint for PEG 3350 laxative powders is not only polymer availability but also powder flow, particle consistency, and dose uniformity, which are sensitive to excipient and packaging system specifications.

Excipients that typically matter in PEG 3350 powders

Even when formulations are “simple,” supply constraints arise from:

• Taste-masking or flavor components (where present by market/package)
• Sodium content controls (if electrolytes or buffering components are used in certain versions)
• Crospovidone or similar agents if included for suspension/dissolution behavior
• Conditioning agents that affect bulk density and blend uniformity

Packaging that affects quality and shelf life

Packaging is frequently a gating item for manufacturing changes:

• Bottle material and headspace oxygen/water vapor permeability
• Moisture barrier liners
• Child-resistant closure systems and liner chemistry compatibility
• Labeling systems that must match carton/bottle codes for traceability

In litigation and regulatory change control, packaging suppliers become relevant when changes trigger:

• Stability re-testing
• Bioburden/sterility claims if any preservation claims exist (typically not for oral non-sterile solids)
• Container-closure integrity studies

Which suppliers provide PEG 3350 bulk polymer used to make Miralax?

Featured snippet answer: PEG 3350 is a bulk chemical/polymer that is commonly sourced from established polymer chemical suppliers. The legally relevant “API supplier” for a given Miralax lot is the one that appears in the manufacturing site’s cGMP supply chain, but Orange Book does not always publicly list the specific bulk chemical vendor.

How to identify PEG 3350 upstream suppliers in practice

For an OTC drug like Miralax, upstream suppliers are identified through:

• FDA establishment registration details for drug substance sites (where disclosed)
• Public supplier qualification documentation (often not public)
• Corporate supply agreements (commercially confidential)

Commercial reality for PEG 3350

Bulk PEG 3350 is produced at scale globally. Supplier switching generally faces:

• Molecular weight distribution and specification compliance
• End-group controls
• Trace impurities (1,4-dioxane, ethylene oxide residuals where applicable)
• Moisture content and variability by production batch

Even when the ingredient is “the same polymer,” grade specification drives regulatory acceptance and QC release.

How many suppliers does Miralax use, and can manufacturers switch PEG 3350 vendors?

Featured snippet answer: The number of PEG 3350 suppliers for Miralax is not determinable from public Orange Book alone; it is determinable from cGMP qualification records and drug master files that are not fully public. Practically, drug makers often qualify multiple polymer vendors, but not always.

Regulatory and quality barriers to switching PEG 3350 suppliers

Switching PEG 3350 sources can require:

• Analytical bridging (molecular weight distribution, viscosity, impurity profile)
• Process validation bridging if blending and dissolution profiles shift
• Stability studies for container-closure and bulk storage
• Regulatory reporting depending on the scope of change

What patent estate or regulatory exclusivity affects Miralax supply and generics?

Featured snippet answer: PEG 3350 laxative has a long history; exclusivity and patent protection are typically limited compared with newer drug classes. The regulatory and patent constraints for supply are less about new entry and more about quality system continuity and any remaining formulation or method-of-use IP, which can vary by jurisdiction.

What Orange Book status typically indicates for generics

On FDA Orange Book, products with expiring or expired patents can allow ANDA entry once patent and exclusivity barriers are cleared. For OTC products, multiple generic/therapeutic equivalents usually exist, meaning Miralax’s supply advantage often depends on:

• Manufacturing capacity
• Distribution and packaging scale
• Trade/channel contracts

What generic entry risks exist for PEG 3350 laxatives like Miralax?

Featured snippet answer: Generic entry risk for PEG 3350 powders is generally lower than for protected new chemical entities, because the active ingredient is commoditized. The primary risk is quality and compliance rather than IP-driven delay.

Typical barriers for generic competition

• Bulk polymer specification alignment
• Dose uniformity and dissolution equivalence
• Impurity control and contaminant profiles
• Stability and container-closure validation

Which companies are challenging Miralax supply through generics, and what litigation matters?

Featured snippet answer: For historical PEG 3350 brands, major litigation tends to center on patent filings tied to specific formulations or processes. Without the specific Orange Book patent listings for Miralax’s NDA and any listed Orange Book patents, the adversary roster cannot be stated precisely.

Miralax FDA status and supply footprint: what is the Orange Book listing?

Featured snippet answer: The Orange Book listing identifies the NDA, applicant, dosage form, and listed patents (if any). That listing is the authoritative starting point for identifying:

• Drug product manufacturers
• Drug substance information (where shown)
• Patent expiration dates and any exclusivity expiration dates

What a supply chain buyer should extract

• NDA holder/applicant
• Manufacturing sites listed for drug product
• Listed patents and their expiration dates
• Any exclusivity codes (if displayed)

Key supplier due diligence checklist for Miralax-like PEG 3350 powders

1. Orange Book manufacturer of record for each market.
2. cGMP establishment registration for each manufacturing site.
3. PEG 3350 grade specifications: molecular weight distribution, viscosity/viscometry controls, impurity panel.
4. Supplier audit history and deviation rates for bulk polymer lots.
5. Container-closure and packaging supplier qualification to protect stability.
6. Change control pathway for upstream polymer switch and blend-process changes.

Key Takeaways

• “Suppliers for Miralax” splits into finished-dose manufacturers (Orange Book) and upstream PEG 3350 polymer sources (qualified by cGMP systems).
• For high-stakes decisions, the authoritative supplier list is built from the Orange Book manufacturer of record and FDA cGMP registrations tied to those manufacturing sites.
• Switching PEG 3350 polymer suppliers is constrained by specification equivalence, impurity profiles, and stability/quality bridging, not by simple ingredient substitution.
• Patent-driven supply constraints are generally less central for long-established PEG 3350 laxatives than for novel biologics or NMEs, but any remaining formulation/process IP depends on the specific Orange Book patent list tied to Miralax’s NDA.

FAQs

1. Is Miralax made by multiple manufacturers in the US?
   The definitive answer is the set of manufacturing sites listed on the Orange Book for the Miralax product.

2. Can manufacturers source PEG 3350 from different global suppliers?
   Yes in principle, but only after meeting PEG 3350 specification and impurity controls and completing required bridging and stability work.

3. Do packaging suppliers affect Miralax regulatory compliance?
   Yes, if the container-closure system changes materially, it can trigger stability and quality validation requirements.

4. Does patent protection significantly restrict generic Miralax?
   For PEG 3350 laxatives broadly, generic access is usually limited more by quality equivalence than by modern IP, but the exact constraint depends on the Orange Book patent status for the Miralax NDA.

5. How do I identify the legally relevant supplier for Miralax procurement?
   Use the Orange Book to identify the applicant and manufacturing site(s) for the finished drug and then map those sites to FDA establishment registrations.

References

1. U.S. Food and Drug Administration. Drugs@FDA / Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Miralax listings). FDA.