Suppliers and packagers for EZETIMIBE

EZETIMIBE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Accord Hlthcare	EZETIMIBE	ezetimibe	TABLET;ORAL	211550	ANDA	Accord Healthcare Inc.	16729-433-10	30 TABLET in 1 BOTTLE (16729-433-10)	2019-10-07
Alkem Labs Ltd	EZETIMIBE	ezetimibe	TABLET;ORAL	209234	ANDA	Major Pharmaceuticals	0904-7103-04	30 BLISTER PACK in 1 CARTON (0904-7103-04) / 1 TABLET in 1 BLISTER PACK	2017-12-23
Alkem Labs Ltd	EZETIMIBE	ezetimibe	TABLET;ORAL	209234	ANDA	Major Pharmaceuticals	0904-7103-10	20 BLISTER PACK in 1 CARTON (0904-7103-10) / 1 TABLET in 1 BLISTER PACK	2017-12-23
Alkem Labs Ltd	EZETIMIBE	ezetimibe	TABLET;ORAL	209234	ANDA	A-S Medication Solutions	50090-3657-0	30 TABLET in 1 BOTTLE, PLASTIC (50090-3657-0)	2017-12-23

Ezetimibe API and Finished-Dose Suppliers: Who Makes It, Where It’s Manufactured, and What to Verify in Supply-Sourcing

Last updated: May 28, 2026

Who supplies ezetimibe active pharmaceutical ingredient (API) globally?

Ezetimibe is typically supplied as a synthetic small-molecule API by specialist chemical manufacturers and contract development and manufacturing organizations (CDMOs). In practice, sourcing feasibility is driven less by API “availability” and more by (1) whether the supplier can produce at the intended GMP site, (2) whether the supplier can support regulatory submissions with DMFs or Drug Master Files equivalents, and (3) whether the supplier’s control strategy supports targeted impurities at the applicant’s specs.

How to identify credible ezetimibe API suppliers

For due diligence and procurement quality control, the supply chain should be validated through:

• Regulatory documentation: DMF/ASMF listing, referenced manufacturing site(s), and CEP/certificates where available.
• Batch traceability: CoA linkage to API lots and impurity profiles.
• GMP status: Inspection outcomes tied to the manufacturing site used for the product submission.

API supplier verification checklist (procurement-grade)

• Confirmation that the supplier’s API manufacturing site matches the submission-referenced site.
• Confirmation that the supplier provides stability data covering proposed retest/expiry windows.
• Confirmation of impurity qualification against the target finished-dose filing’s limits and analytical method constraints.
• Ability to support tech transfer and method bridging if the buyer changes test labs or specifications.

Which companies supply ezetimibe finished dosage forms (tablets) to the market?

Finished ezetimibe tablets are supplied by branded and generic manufacturers through their own manufacturing networks or by CDMOs. The market commonly includes:

• Branded originator distribution via downstream partners in specific geographies.
• Generic tablet suppliers spanning multiple regions, with supply sourced through direct manufacturing or contracted services.

What matters more than brand

Finished-dose suppliers should be evaluated on:

• Strength and formulation match (10 mg is the standard US strength for ezetimibe).
• Bioequivalence strategy (film-coated vs. non-coated differences, dissolution method, and particle-size influence on dissolution).
• GMP documentation supporting the local regulatory file used for market entry.

Common tablet “supplier reality”

Ezetimibe tablet supply is frequently split between:

• Tablet manufacturing sites that differ from the API manufacturing sites.
• CDMO-driven manufacturing for generics where the applicant controls the product file but contracts manufacturing execution.

Which CDMOs manufacture ezetimibe tablets or support ezetimibe formulation development?

Ezetimibe is a small molecule, so it is a typical candidate for generic tablet CDMO capabilities. CDMOs that support oral solid dose manufacturing can usually handle:

• Blending and granulation (when needed for flow/dose uniformity)
• Compression and coating (for coated tablets)
• In-process controls and stability programs
• Method development and validation support for dissolution and impurity methods

What to request from a tablet CDMO

• Confirmation of experience with low-dose uniformity and dissolution method performance for ezetimibe.
• Evidence of GMP runs that align with your scale and packaging requirements.
• Facility readiness for planned filing timelines (ANDA/MAA documentation support).

How does API supply chain structure affect ezetimibe sourcing risk?

Ezetimibe sourcing risk typically clusters in three areas:

1. Single-site dependency for API manufacture (one GMP site supplies multiple finished-dose products).
2. Analytical dependence on specific impurity methods and reference standards used in the regulatory file.
3. Scale-up constraints for impurity control and consistent polymorph/particle-size distributions that drive dissolution.

Supply-risk controls

• Dual-source the API where possible by qualifying a second DMF-linked route.
• Require contract terms for annual impurity trend reporting and deviation notification.
• Use a qualification protocol that tests impurity comparability at the buyer’s acceptance limits.

What supplier documents and regulatory trails should be pulled for ezetimibe procurement?

When procurement is tied to regulatory compliance, the fastest route is to pull:

• DMF/ASMF status and referenced site for ezetimibe API.
• Applicant-referenced manufacturing sites for finished-dose product.
• Inspection histories for relevant sites.

Orange Book and FDA listing used as sourcing anchors

For US market products, the FDA listing and sponsor documentation help anchor:

• The manufacturer who controls the product file
• The strength and dosage form tied to the regulatory submission
• The link to manufacturing and packaging where stated

What generic entry risks exist if you select the wrong ezetimibe supplier?

The biggest operational risks in ezetimibe supply contracts are:

• Impurity drift across API lots that causes rejection under finished-dose specifications.
• Dissolution non-conformance tied to API particle-size or tablet excipient blend ratios.
• Documentation gaps that delay release if the regulatory file requires DMF alignment.

Contract terms that reduce risk

• Lot release conditions tied to buyer-specific analytical acceptance criteria.
• Mandatory COA + impurity method comparability for every lot.
• Audit rights for GMP compliance and for analytical instrumentation calibration verification.

How do ezetimibe supplier choices compare: API-first vs finished-dose contract sourcing?

API-first sourcing (buyer imports API and manufactures or contracts tablet manufacturing):

• Pros: control over tablet manufacturing inputs and specifications.
• Cons: higher documentation and tech-transfer burden.

Finished-dose sourcing (buy tablets from a finished-dose manufacturer):

• Pros: faster market entry and reduced tech-transfer load.
• Cons: less control over formulation execution and changes in manufacturing process.

Decision lens for procurement

• If you need quick supply to support market presence, finished-dose sourcing is often faster.
• If you need long-term cost control and process control, API-first sourcing can be more controllable if the supplier is DMF-aligned and impurity-stable.

Key takeaways

• Ezetimibe supply splits into API manufacturers and tablet/finished-dose manufacturers (or CDMOs).
• Procurement success depends on validating GMP site alignment to regulatory documentation, not just on “who supplies ezetimibe.”
• The critical constraints for ezetimibe are impurity control, impurity method alignment, dissolution performance, and batch traceability.
• Contract structures should enforce impurity trend reporting, audit rights, and lot-by-lot analytical comparability.

FAQs

1. What DMF-linked ezetimibe API sourcing approach reduces regulatory filing delays?
   Use DMF-referenced API manufacturing sites aligned to your target submission’s referenced route and specify lot-level impurity comparability requirements in the contract.

2. Can ezetimibe tablet manufacturing be outsourced to oral solid dose CDMOs reliably?
   Yes for oral solid dose work, but performance hinges on dissolution method transfer and ensuring consistent API particle-size and impurity profiles across lots.

3. What supplier quality issues most often cause ezetimibe lot rejections?
   Impurity profile drift and dissolution non-conformance driven by API physical properties and formulation blend variability.

4. How should you qualify a new ezetimibe API supplier?
   Run comparative impurity and dissolution studies using your target formulation, then lock acceptance criteria to finished-dose specifications.

5. Does ezetimibe sourcing differ by geography for compliance and availability?
   Yes, because GMP site availability and regulatory DMF/ASMF referencing varies by region and influences which manufacturing sites can be used for product submissions.

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References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. U.S. Food and Drug Administration. Drug Master Files (DMF): Information for Industry. FDA.
3. European Medicines Agency. Statements and guidance related to ASMF/CEP and manufacturing site documentation for APIs. EMA.