Suppliers and packagers for MOVIPREP

MOVIPREP

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Salix Pharms	MOVIPREP	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	021881	NDA	Salix Pharmaceuticals, Inc.	65649-201-75	1 KIT in 1 CONTAINER (65649-201-75) * 1 L in 1 POUCH * 1 L in 1 POUCH	2006-10-01
Salix Pharms	MOVIPREP	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	021881	NDA	Salix Pharmaceuticals, Inc.	65649-201-76	1 KIT in 1 CONTAINER (65649-201-76) * 1 L in 1 POUCH * 1 L in 1 POUCH	2006-10-01
Salix Pharms	MOVIPREP	ascorbic acid; polyethylene glycol 3350; potassium chloride; sodium ascorbate; sodium chloride; sodium sulfate	FOR SOLUTION;ORAL	021881	NDA	Oceanside Pharmaceuticals	68682-201-75	1 KIT in 1 CONTAINER (68682-201-75) * 1 L in 1 POUCH * 1 L in 1 POUCH	2006-10-01

Suppliers and packagers for MOVIPREP

Last updated: May 25, 2026

MOVIPREP Suppliers: Who Manufactures and Supplies the Prescription Bowel-Prep (PEG-Electrolyte) in the U.S.?

MOVIPREP (sodium-potassium-magnesium-citrate with polyethylene glycol 3350 and electrolytes) is supplied in the U.S. through FDA-labeled distribution tied to the Orange Book-listed product. For MOVIPREP, the key “supplier” question resolves to the FDA label manufacturer(s) and the commercial distributor(s) shown on the product’s packaging and regulatory listings.

What companies supply MOVIPREP in the U.S.?

Answer (high level): MOVIPREP is marketed under the FDA label and supplied through the product’s labeled manufacturer and its U.S. distribution chain. The only defensible “supplier” set for regulatory and licensing work is the company(ies) identified on the FDA product labeling and the Orange Book record for the specific NDA strength and dosage form.

Who is the labeled manufacturer of MOVIPREP?

The labeled manufacturer is the entity responsible for manufacturing and releasing MOVIPREP batches for the U.S. market under the approved NDA labeling.

Who is the U.S. distributor for MOVIPREP?

The distributor is the entity marketing and distributing the product to wholesalers and healthcare channels, often distinct from the manufacturing site operator.

How do you map “supplier” to an IP and litigation risk view?

For licensing, Paragraph IV, and supply-chain disruption analysis, “supplier” should be treated as:

• Label manufacturer (GMP site and NDA manufacturing responsibility)
• NDA holder/labeler (responsible party for regulatory submissions)
• Marketing/distribution company (commercial counterparties)
• API/excipient suppliers (rarely visible in public databases unless disclosed in patents, DMFs, or procurement disclosures)

What does the Orange Book list for MOVIPREP (NDA holder and listed patents)?

Answer (high level): The Orange Book record provides the NDA holder/labeler and the patent estate for MOVIPREP, which is the practical starting point for identifying the parties most likely involved in sourcing, manufacturing, and defending product-specific IP.

Why Orange Book is the right “supplier registry” for MOVIPREP

Orange Book does not list contract manufacturers or API suppliers by default. It lists:

• NDA number
• Applicant/holder (regulatory entity)
• Patents (drug substance, formulation, method-of-use, packaging, etc.)
• Exclusivity codes and expiration dates (when applicable)

For supply-chain due diligence, Orange Book tells you who controls the NDA and who will be central in any litigation or licensing.

Which MOVIPREP suppliers are responsible for making the polyethylene glycol bowel-prep?

Answer (high level): For MOVIPREP, the manufacturing responsibility falls under the label manufacturer under the approved NDA, and the product’s clinical-grade kit composition is assembled under the same GMP umbrella.

What raw materials define the supply footprint?

MOVIPREP is a combined regimen kit that typically includes:

• PEG 3350 (polyethylene glycol 3350)
• Sodium sulfate-free electrolyte system (sodium, potassium, magnesium ions through citrate/salts per the labeled formula)
• Packaging components for split-dose administration (kit assembly is frequently controlled as a formulation/packaging unit under GMP)

How supplier risk shows up in procurement

In practice, supply chain fragility comes from:

• PEG 3350 sourcing concentration
• Citrate/electrolyte salts availability
• Bottling/blending capacity for the kit components
• Kit assembly line throughput and packaging compliance

Public data often does not name API or excipient suppliers, so the most reliable “supplier” identification remains the labeled manufacturer and distribution company.

Who makes MoviPrep kits: contract manufacturer vs labeler?

Answer (high level): Public-facing “supplier” information for MOVIPREP usually identifies the label manufacturer, not the contract manufacturer. Contract manufacturers for combination bowel preps are often GMP manufacturers under NDA manufacturing agreements, and they are not consistently disclosed in public listings.

What can be inferred from patent and labeling frameworks

When assessing supply chain and potential redesign needs, you can map:

• Manufacturing process dependencies that are reflected in formulation/process patents
• Packaging kit constraints that can create regulatory and supply dependencies
• The labeler’s control of CMC changes

Where can MOVIPREP suppliers be verified for compliance work?

Answer (high level): The verification method used for compliance-grade diligence is:

• The company named on the FDA-approved labeling (package insert and carton labeling)
• The Orange Book applicant/holder for the NDA
• The National Drug Code (NDC) labeling that ties to the specific product label configuration

Because “supplier” can mean multiple roles, the operationally correct supplier set for regulated work is the set appearing on the labeled product and Orange Book record.

Competitive supply landscape: Do other PEG-electrolyte bowel preps share suppliers?

Answer (high level): Many PEG-electrolyte bowel preparations in the U.S. are made by a limited set of large CMO/CDMO and kit-assembly GMP networks. Shared suppliers are common at the manufacturing/kit-assembly level, even when products are marketed by different labelers.

What changes supplier comparisons for bowel-prep kits

The relevant comparison is not only active ingredients but:

• Kit format and assembly steps
• Stability and packaging configuration
• Labeling/regulatory CMC commitments
• Batch release testing method and spec

Public supplier overlap is rarely explicit, so the strongest evidence comes from labeling manufacturer identities and manufacturing site disclosures tied to CMC changes.

What generic or rebranded versions of MOVIPREP would affect supply?

Answer (high level): Generic entry risk and supply diversification depend on the patent estate and whether challengers win approvals. The supply impact occurs when FDA-approved generics launch at scale and displace branded procurement contracts.

How to assess generic entry scenarios from an IP-supply angle

For MOVIPREP, supply planning should be linked to:

• Whether patent barriers block generics
• Whether court settlements allow launch “at risk” or on a date
• Whether any authorized generics exist
• Whether there are shortages, which can be driven by GMP disruptions rather than patent status

How strong is the MOVIPREP patent estate for supplier and generic impact?

Answer (high level): The patent estate strength affects how quickly new suppliers (generic labelers) enter the market. Strong estates slow entry and keep branded manufacturing and distribution dominant.

What you should focus on in the patent estate

• Drug substance and formulation patents (can block CMC redesign)
• Method-of-use patents (can block specific dosing regimen claims)
• Packaging/kit patents (can affect kit assembly and regimen packaging)
• Excipients and processing claims (can restrict rework or substitute compositions)

Key Takeaways

• “Suppliers for MOVIPREP” in regulated contexts should be treated as the label manufacturer and NDA holder/labeler shown in FDA records and product labeling.
• Orange Book is the authoritative source for NDA holder and the MOVIPREP patent estate that drives generic entry timing and supply diversification.
• Public databases typically do not name API or excipient suppliers for PEG-electrolyte bowel preps, so due diligence for supplier identification should start with labeled manufacturer and distribution entities.

FAQs

1. Is MOVIPREP manufactured by the same company that markets it?
   Often the label manufacturer and marketing/distribution company differ, so verification should rely on FDA labeling and Orange Book.

2. Do generic MOVIPREP competitors use the same manufacturing suppliers?
   They may share kit-assembly or CMO capacity, but public disclosures usually do not confirm supplier overlap beyond labeled manufacturer identities.

3. Does MOVIPREP have authorized generic versions?
   Authorized generic status depends on NDA and patent settlement/licensing arrangements and is reflected through FDA listings and market authorization.

4. How do MOVIPREP shortages typically affect supplier chains?
   Shortages usually reflect GMP capacity, kit assembly throughput, or raw material availability (especially PEG and electrolyte components) rather than patent status.

5. Which dataset most reliably identifies MOVIPREP suppliers for procurement?
   FDA product labeling and Orange Book NDA records tied to the exact NDC configuration.

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-05-25).
2. U.S. Food and Drug Administration. Approved Drug Products: MOVIPREP (labeling and application records). (Accessed 2026-05-25).