Suppliers and packagers for generic pharmaceutical drug: MOTIXAFORTIDE ACETATE

MOTIXAFORTIDE 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
Ayrmid Pharma	APHEXDA	motixafortide acetate	POWDER;SUBCUTANEOUS	217159	NDA	Gamida Cell Inc.	73441-062-01	1 VIAL, GLASS in 1 CARTON (73441-062-01) / 1.7 mL in 1 VIAL, GLASS	2025-06-15
Ayrmid Pharma	APHEXDA	motixafortide acetate	POWDER;SUBCUTANEOUS	217159	NDA	BioLineRx USA Inc	82737-073-01	1 VIAL, GLASS in 1 CARTON (82737-073-01) / 1.7 mL in 1 VIAL, GLASS	2023-09-08

Suppliers and packagers for generic pharmaceutical drug: MOTIXAFORTIDE ACETATE

Last updated: May 29, 2026

Motixafortide Acetate Suppliers: Who Manufactures the Active Ingredient, Drug Product, and Key Intermediates?

Motixafortide acetate is a synthetic peptide drug candidate/therapy. Supplier discovery depends on what stage of the value chain is targeted (API vs. finished dosage vs. peptide intermediates), and on the regulatory entity owning the approved/marketed supply chain in each territory.

Actionable supplier targets by category (what to diligence):

• Peptide synthesis contractors (solid-phase peptide synthesis and purification) for the motixafortide acetate active pharmaceutical ingredient (API).
• API salt-formulation specialists (acetate salt formation, crystallization, particle size control).
• cGMP peptide API manufacturers with documented controls for truncation, epimerization, oxidation, and residual solvents/reagents.
• Contract drug product manufacturers for peptide injectables (sterile fill-finish, lyophilization if used, container closure systems, cold-chain logistics).
• Raw material and reagent suppliers for Fmoc-protected amino acids, coupling reagents (if applicable), and purification consumables.

What you should not do in sourcing without dossier-level validation: rely on distributors alone. Peptide therapeutics frequently require supplier qualification tied to CoA specs, impurity profiles, and clinical/registration batch history.

Who supplies motixafortide acetate API (active pharmaceutical ingredient)?

API supplier diligence checklist for motixafortide acetate (peptide API):

• Solid-phase peptide synthesis capacity (peptide length, scale, sequence complexity).
• Purification method capability (prep HPLC or equivalent) and impurity profiling (LC-MS and RP-HPLC methods).
• Salt formation experience for acetate-form peptides.
• Control strategy for peptide-related degradation:
  • oxidation, deamidation (where relevant), disulfide issues (if present), aggregation, and acetylation accuracy (if applicable).
• Ability to provide:
  • CoA for critical attributes
  • batch traceability
  • impurity tables aligned to proposed acceptance criteria
  • analytical method validation packages (regulatory-ready)

API sourcing reality for peptides: the “supplier list” is usually a small number of global peptide CDMOs plus raw-material chains, with qualification requirements driven by regulatory expectations and manufacturing reproducibility.

Which peptide CDMOs are typical API sources for synthetic peptide injectables?

For peptide injectables, the supplier universe is commonly dominated by peptide-specialist CDMOs and large-scale sterile pharmaceutical manufacturers that also run sterile fill-finish for APIs manufactured by upstream peptide specialists. The motixafortide acetate supplier set is determined by who currently supplies clinical/market batches and who has technology transfer rights.

What contract terms govern API supply for peptide salts like motixafortide acetate?

Key contract terms to require in diligence:

• definition of the peptide sequence and modifications (acetate salt confirmation)
• impurity profile ownership and change-control clauses
• analytical method transfer obligations
• stability program data (ICH zones, freeze-thaw if relevant)
• cold-chain responsibilities and shipment lanes

Who supplies motixafortide acetate drug product (finished injectable)?

For peptide therapies, drug product supply is often split:

• upstream API supplier or API contractor
• downstream sterile manufacturing and packaging contractor

What drug product manufacturing capabilities are required?

• Sterile compounding for peptide injectables
• lyophilization capability if the formulation is freeze-dried (common for peptides to manage stability)
• microbiological controls and sterility assurance processes
• container closure system validation for peptide compatibility

What to verify in supplier qualification for motixafortide acetate injectables

• Sterile fill-finish qualification batches
• leachables and extractables testing (container/closure)
• compatibility with solvent system and salt form
• subvisible particle counts, osmolality/pH targets, and moisture control (if lyophilized)

Which companies supply key intermediates and peptide starting materials used for motixafortide acetate?

Supplier mapping for intermediates depends on the exact synthetic route used by the API producer, including:

• Fmoc-protected amino acids
• coupling reagents and capping agents (if used)
• resins and linkers (if applicable)
• solvents for cleavage and purification
• acetate-form intermediates (if the acetate form is introduced late in the route)

What categories of suppliers matter most for peptide intermediates

• Fmoc building block manufacturers (regulated-grade traceability)
• peptide synthesis resins and protected reagents suppliers (consistent quality)
• solvent suppliers with tight residual solvent controls
• chromatography consumables (for purification) that match impurity control requirements

How do you identify the actual motixafortide acetate suppliers in practice (dossier-level and regulatory sources)?

For drug supply intelligence, the most reliable way to identify “real suppliers” is to tie names to:

• CMC sections in regulatory filings
• inspection outcomes tied to manufacturing sites
• product label or submission documents listing manufacturing locations

In a sourcing workflow, the high-signal sources are:

• FDA approval package CMC site listings (when applicable)
• inspection databases showing site involvement
• manufacturer-of-record patterns for sterile fill-finish and API sites
• patent-prosecution or technology-transfer references naming manufacturing partners (where publicly disclosed)

Because supplier names change across development stages, the supplier universe is not stable unless anchored to the current manufacturing sites for the specific dosage form and strength.

What are the manufacturing/IP barriers that limit motixafortide acetate supplier switching?

Peptide drugs typically have switch barriers even when the chemistry seems straightforward.

Common barriers in peptide API and drug product supply

• impurity profile fingerprinting tied to process parameters
• validated analytical methods required for batch release
• restricted access to proprietary purification processes (prep HPLC methods, solvent gradients, fraction selection rules)
• stability data dependency on formulation composition and process
• regulatory expectation to file CMC changes for process and site changes

What causes supply constraints most often in peptide manufacturing?

• limited prep HPLC purification capacity during scale-ups
• bottlenecks in sterile fill-finish scheduling
• cold-chain and lyophilization track capacity (if the product is freeze-dried)
• raw-material lot variability for key protected amino acids

Motixafortide acetate supplier landscape by region: where supply is most likely to concentrate?

Peptide API supply clusters where:

• peptide-specific CDMOs have established peptide synthesis and purification lines
• sterile fill-finish capacity exists for injectables
• regulatory inspection history supports approvals and tech transfer

US-centric and EU-centric implications

• US launches typically require cGMP sites with FDA inspection readiness.
• EU launches align with EMA expectations and QP release site capabilities.

Key takeaways

• Motixafortide acetate sourcing should be treated as a peptide-manufacturing qualification problem, not a simple distributor procurement exercise.
• The supplier set is best understood by separating API peptide synthesis and purification (and acetate salt formation) from sterile drug product manufacturing and fill-finish.
• Switching suppliers for peptide products faces hard barriers: impurity profile control, stability dependence, and CMC change-control requirements.
• Supplier identification must be anchored to current manufacturing-site records and batch-release/CMC documentation for the specific dosage form.

FAQs

1. How do I find the motixafortide acetate API manufacturer-of-record for clinical or commercial batches?
2. What cGMP peptide API tests are most critical for releasing motixafortide acetate API (purity, related substances, potency)?
3. Do peptide injectables like motixafortide acetate typically require lyophilization, and how does that affect CDMO selection?
4. What are the most common change-control triggers when swapping peptide API suppliers for acetate-salt drugs?
5. How do residual solvent and impurity limits differ for peptide synthesis vs. sterile fill-finish suppliers?

References

1. FDA. “Guidance for Industry: Content and Format of Chemistry, Manufacturing, and Controls Information and Establishments for Drug Substances and Drug Products.” (CMC guidance).
2. FDA. “Information on cGMP inspections and enforcement.” (Inspection/establishment resources).
3. EMA. “Guideline on the requirements for quality documentation for medicinal products.” (Quality/CMC expectations).