Suppliers and packagers for generic pharmaceutical drug: eliglustat tartrate

eliglustat tartrate

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494	NDA	Genzyme Corporation	58468-0220-1	4 BLISTER PACK in 1 CARTON (58468-0220-1) / 14 CAPSULE in 1 BLISTER PACK	2014-09-03
Genzyme Corp	CERDELGA	eliglustat tartrate	CAPSULE;ORAL	205494	NDA	Genzyme Corporation	58468-0220-2	1 BLISTER PACK in 1 CARTON (58468-0220-2) / 14 CAPSULE in 1 BLISTER PACK	2014-09-03

Eliglustat Tartrate Suppliers (API, Intermediates, Finished Dose) and Supply-Chain/IP Barriers

Last updated: May 24, 2026

Eliglustat tartrate supply is anchored around branded commercial manufacturing and a limited set of active pharmaceutical ingredient (API) and key intermediate sources due to tightly controlled chemistry and quality systems required for an FDA-approved, single-API oral drug. For supplier due diligence, buyers typically narrow to (i) contract manufacturing organizations (CMOs) that can support commercial-scale oral capsule production, (ii) qualified API vendors for eliglustat tartrate, and (iii) upstream intermediate suppliers that can provide traceable, regulatory-grade material consistent with Drug Substance Master File (DMF) or controlled specification pathways.

Which companies supply eliglustat tartrate (API and finished drug) today?

Answer: The drug is supplied commercially through the branded product supply chain; third-party API and finished-dose sources are typically limited to qualified, audited manufacturers and licensed fill-finish partners. Publicly visible “supplier lists” are inconsistent because eliglustat’s commercial supply is not widely disclosed as an open vendor roster.

What is publicly observable about eliglustat tartrate supply?

• Eliglustat tartrate is marketed in the US as Cerdelga (eliglustat) (oral capsules).
• Commercial sourcing normally involves:
  • An API site(s) producing eliglustat base and converting to eliglustat tartrate for specification.
  • A finished-dose site(s) performing capsule filling (and often packaging).
• In practice, supplier visibility is highest via:
  • FDA approvals and labeling references to manufacturing sites (from review documents where listed)
  • DMF-linked API disclosures (where accessible)
  • Change notifications and contract manufacturing announcements by manufacturers

Who manufactures the finished-dose Cerdelga capsules (CMO/fill-finish)?

Answer: Finished-dose production is typically done by the brand’s commercial manufacturing network and selected CMOs that are authorized for commercial supply under US GMP. Exact site names are not consistently presented in public-facing supplier directories.

Finished-dose supply chain elements buyers screen

• Capsule dosage form readiness:
  • Shell composition control and gelatin source qualification (or non-gelatin where applicable)
  • Powder blending consistency and moisture control
  • Segregation risk management for low-dose potency or uniformity targets
• Tartrate salt control:
  • Salt-form reproducibility and assay acceptance criteria for tartrate content
  • Crystallization or salt conversion step validation status
• Packaging:
  • Bottle configuration, desiccant strategy, and stability container closure integrity

Which suppliers provide eliglustat tartrate API?

Answer: Eliglustat tartrate API is sourced from GMP-compliant API manufacturers that support the drug’s DMF/authorization pathways and commercial QA. Publicly indexed “API supplier lists” are limited and often incomplete.

API due diligence checklist used for eliglustat tartrate qualification

• Regulatory status support:
  • Whether the API is produced under a DMF or is directly referenced in the approved application
  • CoA and impurity profile alignment with the approved specification
• Chemistry controls:
  • Control of key process impurities linked to the synthetic route
  • Chiral purity control consistent with eliglustat’s stereochemical requirements
• Analytical method readiness:
  • LC methods for assay and impurity identity/quantification
  • Salt form confirmation (tartrate ratio and crystalline form characterization as relevant)
• Supply continuity:
  • Batch-to-batch consistency metrics and planned capacity

What intermediate suppliers upstream support eliglustat tartrate API production?

Answer: Upstream suppliers are typically specialized intermediates producers integrated via controlled procurement and NDA-bound technical packages; named intermediate suppliers are rarely listed publicly due to process/IP sensitivity.

Intermediate procurement patterns

• Key upstream drivers:
  • Access to protected intermediates and stereoselective steps
  • Reagent availability and control for elimination of toxicological outliers
• Buyers usually require:
  • Route traceability and impurity bridging strategy
  • Regulatory documentation for impurities and residuals

How does patent and regulatory status affect who can supply eliglustat tartrate?

Answer: Patent and regulatory constraints determine whether alternate API sources are legally and practically able to support generic or authorized supply, which in turn limits the universe of “qualified suppliers” even if raw capability exists.

Patent/IP barriers that typically impact supplier entry

• Composition of matter and salt-related claims for eliglustat and tartrate form(s)
• Process and intermediate claims around synthetic routes
• Method-of-use and clinical regimen claims affecting generic development strategies

What is the Orange Book status of eliglustat tartrate products?

Answer: Eliglustat’s US exclusivity and listed patents are managed through FDA’s Orange Book listings tied to Cerdelga. Supplier substitution depends on when those protections end and whether any Paragraph IV challenges or settlements occurred.

Supplier implications

• If patents are in force, brand-licensed suppliers are often the only compliant commercial sources for “drop-in” API or finished dosage supply.
• If patents approach expiration or have been challenged, the supplier universe can widen via generic API qualification or authorized generics.

Which generic or biosimilar pathways create supplier opportunities for eliglustat?

Answer: For small-molecule drugs like eliglustat, supply expansion generally comes from generic ANDA pathways rather than biosimilars. Supplier opportunities rise when ANDA approvals mature and the market shifts.

What changes when ANDAs launch

• API supply diversification:
  • Multiple API suppliers can emerge once ANDA manufacturing is established
  • Contract manufacturers may bid to support fill-finish
• Pricing pressure:
  • Qualification of alternate upstream sources increases if stability and impurity profiles remain within ANDA specs

What supplier risk exists in eliglustat tartrate manufacturing?

Answer: The main risks are supply concentration, impurity-profile deviation, and salt-form control under GMP.

Concentration risk

• A small number of qualified sites can lead to:
  • Longer lead times
  • Higher commercial leverage held by the brand manufacturing network
  • Limited surge capacity during quality events

Quality and impurity risks

• Salt conversion and crystallization steps are a known sensitivity for tartrate forms.
• Any change in:
  • Reagents
  • Solvents
  • Crystallization conditions
  • Drying profiles can affect:
  • Impurity formation
  • Particle size distribution
  • Solvate/hydrate presence (if relevant)

Competitive landscape: how do supplier capabilities map to drug product supply?

Answer: In this category, “capability” does not translate to “supplier readiness” unless: (i) the site is qualified to produce to the approved spec, (ii) the regulatory pathway is clear, and (iii) the contract includes IP-safe technical packages.

Practical mapping buyers use

• Category A: brand or authorized supply network
• Category B: qualified contract manufacturers that can produce oral solid dose (fill-finish)
• Category C: API suppliers with the right synthetic chemistry and impurity control, but not necessarily approved for this specific product without pathway alignment

Key Takeaways

• Eliglustat tartrate supply is concentrated in a limited, qualified set of manufacturers supporting commercial-scale oral capsule production.
• Named third-party suppliers are hard to verify through public “supplier directories,” because regulatory authorization and DMF/technical package control dominate eligibility.
• Supplier diligence should focus on: tartrate salt control, impurity profile alignment, GMP site qualification, and legal/regulatory pathway fit relative to Orange Book-listed protections.
• Market entry by additional suppliers typically accelerates when ANDA development and approvals progress toward launch readiness.

FAQs

1) Can any API manufacturer make eliglustat tartrate for Cerdelga-style supply?
No. Production must match the approved specification/impurity profile and comply with regulatory authorization and IP constraints.

2) What matters most for eliglustat tartrate’s API quality?
Salt-form control (tartrate content and physical form) and impurity profile management tied to the approved specification.

3) Do fill-finish CMOs need specific authorization for eliglustat capsules?
Yes. They must qualify for oral solid dose GMP, maintain uniformity and stability requirements, and be contractually authorized under the relevant product supply chain.

4) Are there biosimilars for eliglustat tartrate that add supplier diversity?
No. Eliglustat is a small molecule; the parallel development path is generic ANDA-driven supply expansion.

5) What supplier signals predict contract award likelihood for eliglustat?
Validated processes for tartrate salt formation, established impurity control, demonstrated stability capacity for capsule packaging, and documented GMP compliance for commercial-scale oral solids.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
2. FDA. Drugs@FDA: Eliglustat (Cerdelga). U.S. Food and Drug Administration.