Suppliers and packagers for VYTORIN

VYTORIN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687	NDA	Organon LLC	78206-174-01	30 TABLET in 1 BOTTLE (78206-174-01)	2021-06-01
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687	NDA	Organon LLC	78206-174-02	90 TABLET in 1 BOTTLE (78206-174-02)	2021-06-01
Organon	VYTORIN	ezetimibe; simvastatin	TABLET;ORAL	021687	NDA	Organon LLC	78206-175-01	30 TABLET in 1 BOTTLE (78206-175-01)	2021-06-01

Suppliers and packagers for VYTORIN

Last updated: May 29, 2026

Vytorin (ezetimibe/simvastatin) Suppliers: API, Excipients, and Finished-Dose Manufacturing

Vytorin is a fixed-dose combination of ezetimibe and simvastatin. The supply chain is split between (1) APIs for each component and (2) finished-dose tablets made for branded and generic markets. The name “Vytorin” is associated with a branded product line marketed by Merck Sharp & Dohme (MSD). The underlying APIs and tablet supply have historically involved large-scale contract manufacturers for APIs, tablet manufacturing, and secondary packaging, with multiple suppliers varying by geography and batch.

Who supplies ezetimibe and simvastatin APIs for Vytorin?

Direct supplier list for APIs depends on the specific manufacturing site tied to each FDA lot, which is reflected in FDA drug master files, inspections, and label/manufacturing site history. For fixed-dose combinations, the API supply chain is typically managed at arm’s length through approved API manufacturers and controlled drug substance specifications.

What to map in contracts and regulatory filings

• Ezetimibe API manufacturer(s) and alternate sources qualified for commercial supply
• Simvastatin API manufacturer(s) and alternate sources
• Salt/form and polymorph control for simvastatin and impurity specs for both actives
• Cold-chain is not generally required for these APIs; stability and impurity profiles dominate

Supply chain structure used in commercial fixed-dose combination manufacturing

1. API synthesis and purification for ezetimibe and simvastatin
2. API testing and CoA release to combiner site
3. Formulation development-grade to commercial-grade scale-up
4. Blending and compression or granulation (depending on the tablet design)
5. Film coating, imprinting, and finished packaging
6. Lot release testing, serialization where applicable, and distribution

Which companies manufacture Vytorin tablets and package the finished product?

Finished-dose tablets and packaging are typically performed by one or more contract manufacturers with multiple packaging lines. For combination products, tablet manufacturing and coating are often outsourced, while quality systems are aligned to cGMP and to the NDA/labeling for composition and dissolution specifications.

What you should verify operationally

• Finished-dose manufacturing site(s) listed on the FDA label and the distributor/manufacturer section
• Coating facility for film coat, imprint processes, and rejection controls for tablet defects
• Bottling vs. blister packing capacity and primary packaging material suppliers (if supply continuity matters)
• Who performs release testing: manufacturer site lab vs. contract testing lab

What excipients and coating systems are used in Vytorin tablets?

Vytorin tablets use standard solid oral excipient systems plus a film coating. Excipients can change across batches or across lifecycle updates, but typical categories include:

• Tablet diluents and binders (to support granulation and compression)
• Disintegrants (for dissolution)
• Lubricants and glidants (for tablet processing)
• Film-formers and plasticizers for coating
• Opacifiers and colorants/imprinting aids (for identifying strength)

Why excipient sourcing matters

• Fixed-dose products require tight control of dissolution and disintegration time
• Coating polymers and plasticizers can be single-source during certain periods, creating discontinuity risk
• Colorants and imprinting inks are regulated materials with batch consistency requirements

Are there multiple API suppliers for ezetimibe or simvastatin in the Vytorin supply base?

Large commercial APIs like ezetimibe and simvastatin generally have multiple qualified sources. Fixed-dose combination supply contracts usually include:

• Primary API supplier
• One or more qualified alternate suppliers with established impurity profiles
• Ongoing qualification for change control under cGMP

How this is controlled in practice

• Analytical method alignment across sources (HPLC impurity panel)
• Acceptance criteria for critical impurities and residual solvents
• Stability commitment and re-test dating based on commercial storage conditions
• Audit programs for cGMP compliance and data integrity

How does supplier selection affect Vytorin launch and generic readiness?

Fixed-dose supplier risk affects branded supply continuity and can also influence generic entry readiness via comparability of:

• Drug product dissolution performance
• Tablet microstructure and disintegration behavior
• Impurity profile in the final drug product

For generics, the supplier base can differ from the branded product. If the generic uses alternate API sources, it still must meet AB-rated quality and FDA-approved specs. This can change development timelines when there are impurity or dissolution mismatches.

What is the Orange Book status for Vytorin and what does that imply for supply/competition?

Patent and exclusivity status determines competitive pressure, not the manufacturing supplier list by itself. Orange Book listings typically govern:

• Market exclusivity expiry dates
• Composition, formulation, and method-of-use patent coverage
• Use of Paragraph IV routes for generics and the timeline for entry

For a supplier plan, the key linkage is whether generics are likely to enter soon, which drives pricing pressure and procurement tightening by branded manufacturers and distributors.

What is the finished-dose manufacturing model for combination tablets like Vytorin?

Combination tablets usually follow one of two models:

1. A single contract manufacturing organization (CMO) handles both formulation and finished-dose tablet production.
2. The combiner site receives intermediate blends or individual APIs from multiple qualified suppliers and performs formulation and compression in-house.

Operationally relevant distinctions

• Whether the CMO does granulation vs direct compression
• Whether coating is done in the same facility (fewer handoffs, tighter batch control)
• Whether QA release testing is done at-site or through a contract quality lab

Which jurisdictions’ suppliers typically matter most for Vytorin supply?

Commercial supply chains for ezetimibe and simvastatin APIs commonly rely on established manufacturing hubs for small-molecule APIs and solid oral finished-dose production. Supplier performance is driven by:

• cGMP inspection outcomes
• ability to maintain impurity control and documentation completeness
• capacity to handle scale-up and change control

The jurisdiction list is frequently not static, because supplier qualification is batch and period dependent.

Vytorin supply continuity: what supplier risks are most likely to disrupt availability?

Key disruption vectors in small-molecule oral solids:

• API batch failure due to impurity specification drift
• Variation in residual solvents or polymorphic behavior
• Tablet coating defects tied to polymer quality or plasticizer supply
• Packaging material shortages that prevent lot release despite drug product readiness

For combination products, any upstream delay can halt the entire finished-dose line.

Key Takeaways

• Vytorin supply is driven by two parallel API supply streams (ezetimibe and simvastatin) feeding one or more finished-dose tablet manufacturing sites and packaging operations.
• Supplier identification in fixed-dose brands is site- and period-specific, reflected in FDA labeling/manufacturing site histories and batch-level regulatory traceability.
• Procurement risk is highest where impurity control, dissolution performance, and coating material consistency must be maintained under cGMP change control.
• Patent/exclusivity status affects commercial pricing pressure more than it directly changes supplier rosters, but it can affect inventory policies and procurement leverage as generic entry risk increases.

FAQs

1) Who is the marketing authorization holder for Vytorin?
Vytorin is marketed by Merck Sharp & Dohme.

2) Are ezetimibe and simvastatin sourced from different API suppliers?
Typically yes, with each active having its own qualified API supplier and alternates.

3) What level of supplier qualification is required to change an API source for Vytorin?
Changes require cGMP change control with impurity profile alignment, method validation bridging, and stability data commitments.

4) What is more likely to cause Vytorin shortages: API or tablet coating?
Either can, but API impurity drift and coating material variability are frequent operational risk points for solid oral products.

5) Do generic entrants use the same API suppliers as the branded Vytorin?
Not necessarily; generics can use different qualified API manufacturers while still meeting FDA quality specs.

References (APA)

1. FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. (n.d.). Drugs@FDA: Vytorin (ezetimibe and simvastatin). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
3. FDA. (n.d.). Labeling for Vytorin (ezetimibe and simvastatin). U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/