Last Updated: May 12, 2026

Suppliers and packagers for generic pharmaceutical drug: GANIRELIX ACETATE


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GANIRELIX ACETATE

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Sun Pharm FYREMADEL ganirelix acetate INJECTABLE;INJECTION 204246 ANDA Ferring Pharmaceuticals Inc. 55566-1010-1 1 BLISTER PACK in 1 CARTON (55566-1010-1) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE 2022-02-28
Amphastar Pharms Inc GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 212613 ANDA Amphastar Pharmaceuticals, Inc. 0548-5001-00 1 SYRINGE in 1 CARTON (0548-5001-00) / .5 mL in 1 SYRINGE 2022-06-20
Gland GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 215658 ANDA Fresenius Kabi USA, LLC 65219-028-05 1 SYRINGE, GLASS in 1 CARTON (65219-028-05) / 1 mL in 1 SYRINGE, GLASS 2023-03-24
Gland GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 215658 ANDA Gland Pharma Limited 68083-472-01 1 BLISTER PACK in 1 CARTON (68083-472-01) / 1 SYRINGE, GLASS in 1 BLISTER PACK / 1 mL in 1 SYRINGE, GLASS 2023-02-28
Gland GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 215658 ANDA Xiromed LLC 70700-327-98 1 SYRINGE, GLASS in 1 CARTON (70700-327-98) / 1 mL in 1 SYRINGE, GLASS 2024-04-01
Lupin Ltd GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 216075 ANDA Lupin Pharmaceuticals, Inc. 70748-274-01 1 TRAY in 1 CARTON (70748-274-01) / 1 SYRINGE, GLASS in 1 TRAY / 1 mL in 1 SYRINGE, GLASS 2024-02-14
Meitheal GANIRELIX ACETATE ganirelix acetate INJECTABLE;INJECTION 214996 ANDA Meitheal Pharmaceuticals Inc. 71288-554-80 1 BLISTER PACK in 1 CARTON (71288-554-80) / 1 SYRINGE, GLASS in 1 BLISTER PACK / .5 mL in 1 SYRINGE, GLASS 2022-06-06
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for generic pharmaceutical drug: GANIRELIX ACETATE

Last updated: April 25, 2026

GANIRELIX ACETATE: Who supplies the active ingredient and how to map the supply base

What companies supply ganirelix acetate (API) today?

Ganirelix acetate is typically supplied as an injectable peptide API and is sold under the “ganirelix acetate” name or as a packaged API for use in gonadotropin-releasing hormone antagonist formulations. The supplier universe is dominated by peptide-capable manufacturers and contract API producers serving branded and generic injectable programs.

Representative API and peptide suppliers (ganirelix acetate)

Supplier Typical offering Product context Evidence (source)
Merck (MilliporeSigma) Reference material and/or API supply channels for pharmaceutical chemicals and peptides Distributed through Sigma-Aldrich/MilliporeSigma catalog channels used by research and industry MilliporeSigma listing exists for ganirelix acetate (catalog presence) [1]
Bachem Peptide manufacturing and supply (incl. peptide building blocks and APIs) Peptide specialist vendor used across CDMO and API supply for peptide drugs Bachem lists ganirelix acetate in its product catalog [2]
MedChemExpress (MCE) Research-grade material and small-batch supply channel Commonly used for R&D sourcing of peptide compounds MCE lists ganirelix acetate [3]
Chem-Impex Peptide chemical supply Catalog supplier for peptide intermediates and API-grade materials Chem-Impex lists ganirelix acetate [4]
Cayman Chemical Research reagent supply Supplier channel for peptide reference compounds Cayman lists ganirelix acetate [5]
Toronto Research Chemicals (TRC) Research reagent supply Supplier channel for peptide reference compounds TRC lists ganirelix acetate [6]

How to interpret this list for pharma procurement: catalog availability indicates commercial readiness and supply capability, but it does not by itself prove GMP API status for injectable manufacture. For procurement tied to clinical or commercial manufacturing, the practical supplier set is the companies that (1) hold GMP peptide API capability, (2) can provide CoA with appropriate specs, and (3) support regulatory documentation for injectable peptide drugs.


What supplier archetypes exist for ganirelix acetate?

Ganirelix acetate supply splits into two practical routes:

  1. Peptide-specialist API manufacturers and CDMOs

    • Focus on scalable peptide synthesis, purification, and regulatory documentation for peptide APIs.
    • Typical customers: branded drug makers, generic manufacturers, sterile injectable developers.
  2. Chemical catalog suppliers (reagent channels)

    • Provide ganirelix acetate as a listed chemical for R&D, analytical work, and early-stage development.
    • Used as lead sourcing for method development, but procurement for injectable product requires GMP qualification.

This matters because injectable peptide programs require strict control over:

  • identity and purity (including deamidation and related impurities)
  • chain integrity and fragmentation
  • residual solvents
  • endotoxin/bioburden constraints for downstream sterile fill-finish (formulation dependent)

What does “API supplier” mean in practice for injectable peptide drugs?

For ganirelix acetate, the supply chain expectation is usually:

  • API supply: GMP peptide API with batch records, CoA, impurity profile, and validated analytical methods.
  • Formulation interface: sterile manufacturing requires strict control of peptide handling, filtration strategy, and container closure compatibility.
  • Regulatory: dossiers and DMFs (where applicable) or supplier qualification packages for controlled manufacturing.

So, procurement targets suppliers that provide:

  • GMP manufacturing documentation
  • consistent impurity profiles across lots
  • stable lead times and QC support for peptide-specific analytics

Catalog pages alone should be treated as “availability signals,” not proof of GMP release.


Where does ganirelix acetate show up in common pharma supply sources?

Ganirelix acetate is widely indexed across global chemical catalogs and peptide suppliers, which signals commercial supply capacity.

Public catalog presence by supplier

Supplier catalog channel Evidence type What it indicates for sourcing
MilliporeSigma Product listing Chemical supply channel availability [1]
Bachem Product listing Peptide specialist supply capability signal [2]
MedChemExpress Product listing R&D chemical supply channel [3]
Chem-Impex Product listing Peptide chemical supply channel [4]
Cayman Chemical Product listing Research reagent supply channel [5]
TRC Product listing Research reagent supply channel [6]

Actionable approach: building a shortlist for vendor qualification

How to build an investable shortlist from the open supplier universe

For ganirelix acetate, a workable shortlist can be created by narrowing from “catalog suppliers” to “injectable-ready suppliers” using the following selection logic:

  1. Peptide specialist providers

    • Prioritize peptide manufacturing specialists and established peptide suppliers because ganirelix is a synthetic peptide with peptide-specific quality risks.
    • Example archetype: Bachem [2].
  2. Large branded chemical distributors with GMP pathways

    • Where the supplier is a major distributor or vertically integrated chemical supplier, confirm GMP API capability through procurement documentation and qualification.
    • Example archetype: Merck/MilliporeSigma [1].
  3. Reagent-channel suppliers used only for non-GMP uses

    • Use only for analytical development or method screening unless and until they provide GMP API evidence and batch documentation appropriate for sterile injectable workflows.
    • Examples: MCE [3], Chem-Impex [4], Cayman [5], TRC [6].

This sequencing prevents project schedule risk from the common failure mode: sourcing a peptide from a catalog supplier and only later discovering that GMP API documentation is not available or not aligned with injectable needs.


What supplier due-diligence points matter for ganirelix acetate?

When qualifying suppliers for ganirelix acetate, focus on proof that supports peptide API control:

  • Analytical release specs
    • identity and purity (including relevant related substances)
    • appearance and physical form control
  • Impurity profile consistency
    • peptide-specific degradation pathways
  • Manufacturing controls
    • synthesis reproducibility and purification validation
  • Documentation readiness
    • CoA content and traceability
    • batch-to-batch comparability

These points determine whether the supplier can pass downstream qualification in sterile injectable manufacturing.


Key Takeaways

  • Ganirelix acetate shows broad commercial availability across peptide and chemical catalog suppliers, with peptide specialists and large chemical distributors forming the core public supplier set.
  • Public listings include Merck (MilliporeSigma), Bachem, MedChemExpress, Chem-Impex, Cayman Chemical, and Toronto Research Chemicals.
  • For injectable-ready procurement, the practical supplier target is the subset that can provide GMP peptide API documentation, CoA with peptide-specific analytics, and consistent impurity control, not just catalog availability.

FAQs

  1. Is ganirelix acetate supplied mainly as GMP API or as research reagent?
    Publicly, it is widely listed in reagent catalogs, but GMP API sourcing requires supplier qualification and documentation beyond product listing.

  2. Which suppliers are best starting points for peptide API qualification?
    Start with peptide specialists (for example, Bachem) and major chemical suppliers with established manufacturing/QC pathways (for example, Merck/MilliporeSigma) and then verify GMP suitability through procurement documentation [1], [2].

  3. Can catalog suppliers (e.g., MCE, Cayman, TRC) be used for injectable manufacturing?
    They are commonly used for R&D and analytical needs; injectable manufacturing requires GMP API capability and regulatory documentation aligned to sterile peptide drug workflows [3], [5], [6].

  4. What is the most critical qualification risk for peptide API sourcing?
    Ensuring consistent peptide integrity and impurity profile across lots, supported by peptide-specific release testing and documentation readiness.

  5. How should a procurement team structure vendor onboarding for ganirelix acetate?
    Use an initial shortlist from peptide specialists and large distributors, then move quickly to compliance checks: CoA content, analytical methods, impurity specifications, and GMP manufacturing documentation.


References

[1] MilliporeSigma. (n.d.). Ganirelix acetate. Sigma-Aldrich/MilliporeSigma product listing.
[2] Bachem. (n.d.). Ganirelix acetate. Bachem product catalog entry.
[3] MedChemExpress. (n.d.). Ganirelix acetate. Product listing.
[4] Chem-Impex. (n.d.). Ganirelix acetate. Product listing.
[5] Cayman Chemical. (n.d.). Ganirelix acetate. Product listing.
[6] Toronto Research Chemicals. (n.d.). Ganirelix acetate. Product listing.

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