Share This Page
Suppliers and packagers for generic pharmaceutical drug: BEMPEDOIC ACID; EZETIMIBE
✉ Email this page to a colleague
BEMPEDOIC ACID; 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 |
|---|---|---|---|---|---|---|---|---|---|
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617 | NDA | Esperion Therapeutics, Inc. | 72426-818-03 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-818-03) | 2020-03-09 |
| Esperion Theraps Inc | NEXLIZET | bempedoic acid; ezetimibe | TABLET;ORAL | 211617 | NDA | Esperion Therapeutics, Inc. | 72426-818-99 | 7 TABLET, FILM COATED in 1 BLISTER PACK (72426-818-99) | 2020-03-09 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Bempedoic Acid + Ezetimibe Suppliers: Who Manufactures the APIs, Key Intermediates, and Finished Dosage Forms (US and EU)
Bempedoic acid and ezetimibe are supplied through a multi-tier value chain: API manufacturers (and intermediates) supply contract manufacturers (CDMOs) that convert APIs into finished tablets under FDA-registered sites. Supplier lists in this segment are driven by (1) US/EU API registrations, (2) Drug Master File (DMF) support for impurity control and analytical methods, (3) ANDA/505(b)(2) compatibility for formulation and bioequivalence, and (4) existing commercial supply for branded combination products.
This analysis maps supplier categories and the supplier archetypes used across bempedoic acid and ezetimibe commercial supply.
Who supplies bempedoic acid API and related intermediates?
Answer (commercially relevant supplier archetypes): bempedoic acid API is typically supplied by large Asian and European specialty API manufacturers with validated routes, controlled impurity packages, and DMF readiness, often paired with intermediate capacity (carboxylic acid precursors, ester intermediates, and late-stage oxidation/reduction steps). Finished-dose manufacturing is performed by FDA-registered CDMOs that handle solid oral dosage forms (film-coated tablets) at scale.
API supply chain pattern for bempedoic acid
- Tier 1 (API manufacturer): supplies bempedoic acid API with impurity specifications, residual solvent control, and stability data.
- Tier 2 (intermediate suppliers): supply key intermediates that determine impurity profile and batch yield.
- Tier 3 (CDMO for solid oral): granulation, blending, compression, film coating, and packaging on drug-product lines.
- Tier 4 (packaging and secondary logistics): bottle filling, strip packaging, serialization.
How to identify bempedoic acid suppliers in practice
- FDA DMF / API registration signals: API manufacturers that support ANDA references and 505(b)(2) dossiers often have active DMFs.
- cGMP site footprint: FDA registered sites for solid dosage manufacturing and API manufacturing.
- Commercial partnership patterns: brands commonly source through CDMOs with multiple API vendors to de-risk supply.
Who supplies ezetimibe API and intermediates?
Answer (commercially relevant supplier archetypes): ezetimibe is supplied by established API firms with scalable synthetic capacity. Ezetimibe’s supply is dominated by companies that can deliver consistent impurity profiles and robust analytical package support, including chiral purity and related substance control where applicable.
API supply chain pattern for ezetimibe
- Core synthetic route control: impurity management is typically a gating factor for generic filing.
- Intermediate availability: the supply base includes suppliers for multi-step building blocks feeding key late-stage esterification/conjugation chemistry.
- Stability and polymorph control: supplier choice is driven by solid-state characterization and shelf-life performance for tablet manufacturing.
Where ezetimibe tends to bottleneck
- High-purity starting materials and tight residual solvent constraints for tablet-ready API.
- Batch-to-batch impurity consistency that reduces reformulation risk and bioequivalence friction.
Which companies manufacture the bempedoic acid + ezetimibe combination tablets?
Answer (category level): the combination drug-product manufacturing is performed by FDA-registered solid oral CDMOs with validated tablet compression and film-coating capabilities. API sourcing is split across qualified API vendors to maintain continuity of supply.
Combination product manufacturing model
- API qualification: drug sponsors qualify multiple API suppliers or maintain a primary API supplier plus backup.
- Drug product transfer packages: tablet formulation, dissolution targets, coating composition, and process parameters.
- Batch release strategy: quality agreement controls impurity thresholds and analytical method equivalence.
How do API supplier choices affect FDA submissions for bempedoic acid and ezetimibe?
Answer: supplier choice affects ANDA and 505(b)(2) readiness through impurity control, polymorph behavior, and reproducibility of the analytical package (assay and related substances).
Key dossier dependencies
- Impurity profile mapping: API vendor changes can force revalidation.
- DMF compatibility: if the API is covered by a DMF, the sponsor’s ability to reference it can speed filing.
- Particle size distribution: influences blend uniformity and dissolution.
- Moisture uptake and stability: affects shelf-life and packaging specifications.
What Orange Book and regulatory listings matter for supplier selection?
Answer: Orange Book listings drive generic/505(b)(2) competition timelines, while FDA regulatory filings dictate which supplier routes can support substitution.
What to monitor for supplier qualification workflows
- Listed patents tied to drug substance or formulation
- Exclusivity periods (NCE, 505(b)(2), pediatric, interchangeability)
- FDA approval pathway for the reference-listed product
- DMF cross-referencing by ANDA filers
When do bempedoic acid and ezetimibe lose exclusivity, and how does that change supplier demand?
Answer: exclusivity loss typically shifts volume from branded procurement to a larger pool of qualified generic supply chains, increasing the number of API and CDMO-qualified vendors.
Demand shift mechanics
- Patent and exclusivity cliffs increase tender frequency.
- CDMO lines expand for solid oral capacity.
- API pricing compresses as competing supplier capacity comes online.
How many patents cover bempedoic acid and ezetimibe formulations, methods of use, and processes?
Answer: patent estates for this therapeutic class usually include drug substance synthesis/impurities, solid-state form claims, composition-of-matter or composition claims, and method-of-use for lipid-lowering.
Supplier relevance of patent scope
- Process patents can restrict which routes API suppliers use.
- Impurity/procedure claims can affect whether the API vendor can legally supply to a competitor.
- Formulation patents can dictate which CDMOs can run a legally compliant process.
What generic entry risks exist for bempedoic acid and ezetimibe tablet supply chains?
Answer: risks concentrate in two areas: (1) patent enforcement around formulation/process and (2) FDA refusals tied to bioequivalence failures caused by supplier-linked API physical form differences.
Risk vectors
- API polymorph or particle size divergence driving dissolution nonconformance.
- Related substances drift increasing OOS rates and delaying batch release.
- Late-stage process transfer failures when CDMOs switch from one API vendor to another.
Which CDMOs are typical manufacturing partners for bempedoic acid/ezetimibe tablets?
Answer (industry-structure): CDMOs are selected based on solid oral platform capability, regulatory track record, tablet line performance, and the ability to manage both APIs under QMS and quality agreements.
Selection criteria used by sponsors
- FDA inspection history for oral dosage lines
- Coating performance capability for film-coated tablets
- Analytical method lifecycle management for release and stability
- Scale-up reproducibility for blend uniformity and dissolution
Supplier landscape comparison: bempedoic acid vs ezetimibe
| Attribute | Bempedoic acid | Ezetimibe |
|---|---|---|
| Supply chain | Specialty API with controlled impurity package | Mature API supply with strong route control |
| Drug product risk driver | Physical form stability and impurity-driven release | Dissolution consistency and related substances |
| Generic readiness friction | API vendor switch can change impurity profile and dissolution | Often easier due to longer commercial history, but still impurity-sensitive |
| Typical CDMO fit | Solid oral (film-coated) tablets, robust stability program | Same platform, with strong dissolution and particle size control |
Key Takeaways
- Bempedoic acid and ezetimibe supply chains rely on qualified API vendors plus FDA-registered solid oral CDMOs for tablet manufacturing.
- Supplier changes drive regulatory friction through impurity profile variance, particle size, and solid-state behavior that can impact dissolution and bioequivalence.
- Combination tablet manufacturing is typically handled by solid oral platforms with multi-source API qualification to reduce supply disruption risk.
- Generic and exclusivity timelines increase demand and expand the number of qualified supply vendors, compressing API and drug-product costs while increasing patent and regulatory compliance pressure.
FAQs
- What criteria do sponsors use to qualify a new bempedoic acid API supplier for tablet manufacturing?
- How does ezetimibe API particle size impact dissolution and batch release in film-coated tablets?
- Do bempedoic acid and ezetimibe require the same CDMO solid oral tablet capabilities, or do they differ by formulation risk?
- What supplier-related changes most commonly cause ANDA bioequivalence failures for lipid-lowering tablet products?
- Which regulatory documents (DMF, site registrations, CMC sections) most directly indicate usable bempedoic acid and ezetimibe API suppliers?
References
No sources were provided in the prompt, and no verified supplier/company list or regulatory filing identifiers were supplied to cite.
More… ↓
