Suppliers and packagers for NEXLETOL

NEXLETOL

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	NEXLETOL	bempedoic acid	TABLET;ORAL	211616	NDA	Esperion Therapeutics, Inc.	72426-118-03	30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72426-118-03)	2020-03-06
Esperion Theraps Inc	NEXLETOL	bempedoic acid	TABLET;ORAL	211616	NDA	Esperion Therapeutics, Inc.	72426-118-99	7 TABLET, FILM COATED in 1 BLISTER PACK (72426-118-99)	2020-03-06

NEXLETOL (bempedoic acid) suppliers: API, CDMO, and packaging sources

Last updated: June 3, 2026

NEXLETOL (bempedoic acid) is supplied in the US by a small set of corporate entities tied to Hikma/Hikma-like distribution and the underlying originator supply chain, with manufacturing and packaging performed through contract manufacturing and packaging networks. Public, regulator-facing supplier disclosure is limited outside the FDA drug master file (DMF) and facility listings, so supplier qualification for launches typically relies on Orange Book site listings, DMF references, and BDDCS/label excipient manifests for formulation-level constraints.

Who manufactures NEXLETOL (bempedoic acid) and supplies the US market?

Answer: NEXLETOL is marketed in the US by Esperion Therapeutics and is supplied via contract manufacturing and packaging performed by companies that hold FDA-inspected facilities referenced in the drug product’s application and associated DMFs.

Market authorization and labeling chain

• NDA holder/marketer: Esperion Therapeutics
• Drug product: Oral tablets containing bempedoic acid (NEXLETOL)
• Supply model: Product manufacturing and packaging through CDMO facilities referenced in FDA databases and inspection records, with API production often supported by DMFs.

What API suppliers make bempedoic acid for NEXLETOL?

Answer: Bempedoic acid API supply is typically handled by specialized API manufacturers via DMF-linked processes. Public-facing supplier names are not consistently visible without pulling the specific Orange Book “Manufacturing Site” entries and the DMF letters of authorization for bempedoic acid.

What controls bempedoic acid API sourcing

• DMF dependence: API process, intermediates, and specs are commonly controlled via DMFs.
• Process validation: Scale-up and change control are tied to the API manufacturing site qualification.
• Impurity profiles: Regulatory release depends on impurity specs aligned to the NDA.

How many manufacturing sites are listed for NEXLETOL on the Orange Book?

Answer: The Orange Book typically lists drug product manufacturing/packaging sites and may list the labeler/distributor. However, supplier counts must be pulled directly from the Orange Book entry for NEXLETOL by strength and dosage form to be exact.

Orange Book site listing is the fastest route to named suppliers

Orange Book listings for NEXLETOL provide:

• Manufacturing sites (drug substance and/or drug product depending on entry completeness)
• Packaging sites
• Labeler/manufacturer entities

Which CDMOs supply NEXLETOL tablet manufacturing and packaging?

Answer: NEXLETOL tablet manufacturing and packaging is typically handled by CDMOs with FDA-inspected facilities. Identifying specific CDMO names requires the product’s FDA manufacturing site list.

Tablet formulation constraints that narrow CDMO selection

• Oral solid dose requires:
  • powder blending and granulation controls
  • tablet compression and coating
  • stability and dissolution performance under approved methods
• Packaging must protect moisture and mechanical integrity:
  • desiccant and moisture barrier selection
  • bottle or blister configuration per label

Does NEXLETOL use any common excipient suppliers or shared formulation suppliers?

Answer: NEXLETOL’s excipients are supplier-dependent at the formulation level, but the label generally lists excipient types, not vendor identities. Vendor-level excipient sources are usually not publicly identified and are controlled through procurement specs and supplier qualification files.

How excipient sourcing affects change control

• excipient grade and supplier changes can trigger:
  • comparability studies
  • stability requalification
  • regulatory notification if material changes are involved

What are the strongest “supplier signals” for NEXLETOL in FDA data?

Answer: The most actionable supplier signals are:

1. Orange Book manufacturing/packaging sites
2. NDA and DMF references for bempedoic acid API and key intermediates
3. Inspection outcomes for relevant facilities (FDA Establishment Inspection Reports)
4. Labeler/manufacturer and distributor names on product labeling

Supplier mapping workflow used in licensing and litigation

• Step 1: Pull Orange Book manufacturing site names for NEXLETOL tablets
• Step 2: Map those sites to CDMO entities
• Step 3: Pull DMF-linked API sources for bempedoic acid
• Step 4: Cross-check facility inspection history for risk scoring

How do Par IV generic entry risks relate to NEXLETOL supplier capacity?

Answer: Supplier bottlenecks typically drive launch risk more than IP does in later-life generics because FDA bioequivalence and chemistry, manufacturing, and controls (CMC) must be demonstrated using an approved manufacturing strategy.

What generic applicants must replicate

• dissolution performance and tablet design
• impurity profile and polymorph control for bempedoic acid
• validated blending and compression parameters
• stability and container closure integrity

How does NEXLETOL compare to COL (another bempedoic acid product) supplier footprint?

Answer: NEXLETOL is bempedoic acid monotherapy; it is often compared in the market to fixed-dose combinations (for example with ezetimibe). Supplier footprint can differ because combination tablets may require different coating systems, compression recipes, and combination blend manufacturing line strategies.

Why combination products can change the supplier map

• shared API source may remain constant
• formulation and tablet architecture typically changes
• manufacturing line and packaging line constraints may shift to different CDMOs

Timeline: when do supplier changes typically occur for NEXLETOL?

Answer: Supplier changes are usually documented via:

• prior approval supplements (PAS) for material process changes
• annual reports for minor changes
• revalidation and stability updates post-site change

Launch and lifecycle drivers

• post-approval expansion of capacity
• contract renegotiations
• regulatory remediation at underperforming facilities

Key Takeaways

• NEXLETOL supply is structured through CDMO-based manufacturing and packaging tied to the FDA-inspected facility list and DMF-backed API process control.
• The most precise supplier identification comes from Orange Book manufacturing/packaging site entries and DMF references for bempedoic acid.
• Launch readiness for generics depends on replicating NEXLETOL’s CMC controls and facility-qualified unit operations, so supplier capacity and inspection history are material risk factors.

FAQs

1. What does the Orange Book list for NEXLETOL manufacturing and packaging sites?
2. How can you identify the bempedoic acid API manufacturer for NEXLETOL from FDA records?
3. Which facilities are inspected for NEXLETOL tablet manufacturing under current GMP compliance?
4. Do NEXLETOL and bempedoic acid generic tablets use the same packaging formats and closure systems?
5. What CMC evidence do generic applicants need when switching API or tablet manufacturing sites for NEXLETOL?

References

1. U.S. FDA. Orange Book: Approved Drug Products. (NEXLETOL, bempedoic acid). U.S. Food and Drug Administration.
2. U.S. FDA. Drugs@FDA: NEXLETOL (bempedoic acid). U.S. Food and Drug Administration.
3. U.S. FDA. Drug Master Files (DMF) and related FDA submission pathways (public-facing guidance). U.S. Food and Drug Administration.