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Suppliers and packagers for APHEXDA
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APHEXDA
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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for APHEXDA
APHEXDA suppliers: Who manufactures and supplies the drug product, active ingredient, and key components?
Executive summary:
No complete, verifiable supplier map for “APHEXDA” can be produced from the information provided. A supplier analysis requires the drug’s active ingredient(s), dosage form(s), and the exact marketed product identity used in FDA systems (e.g., NDC labeling, Orange Book listing, or licensing records). Without those identifiers, any “supplier” list would be guesswork, not patent-grade or regulatory-grade intelligence.
What suppliers make APHEXDA (active ingredient and finished drug product)?
Featured snippet answer: Cannot be stated from the provided input because “APHEXDA” is not enough to reliably identify the regulated drug product and its labeled strength/dosage form.
Which upstream manufacturers typically supply drug substance for branded oral/sterile products?
For supplier mapping in pharmaceutical supply chains, the critical entities are:
- Drug substance (API) manufacturer named on DMF/CTD cross-references
- Finished dosage form (DP) manufacturer on the label and FDA submissions
- Fill-finish site (if sterile) and packaging site (if separate)
- Key raw-material suppliers (excipients, conjugates, biologics starting material, lyophilization services)
No such entities can be anchored to “APHEXDA” without the product’s regulated identifiers.
How do you confirm an actual supplier for a marketed drug?
In litigation-grade and procurement-grade diligence, confirmation usually comes from:
- FDA Orange Book (for listed drug and patents) and label/manufacturer fields
- FDA NDC Directory entries (labeler and manufacturing info)
- DMF references in FDA review documents (API supplier)
- Establishment inspection records (site verification)
Those sources cannot be tied to APHEXDA from the provided input.
Which companies supply APHEXDA to the US market (NDC labeler and distributors)?
Featured snippet answer: Cannot be provided without the NDC labeler identity for APHEXDA.
What roles exist in the APHEXDA distribution chain?
A US drug supply chain often splits across:
- Labeler (market authorization holder on the NDC)
- Manufacturer (DP and sometimes API)
- Wholesale distributor (distribution network)
- GPO/IDN contract suppliers (secondary channel entities)
No APHEXDA-specific mapping is possible without NDC-level identification.
What does the Orange Book list for APHEXDA and how does that identify suppliers?
Featured snippet answer: Not determinable from the provided input because Orange Book “listed drug” entries require the correct drug name, active ingredient, and dosage form to match.
How Orange Book helps supplier sourcing
Orange Book listing and patent holder data can link to:
- The approved manufacturer(s) for each NDA/BLA supplement
- The holder most likely to control supply or licensing terms
- Platform patent coverage that constrains CMO/API switching
No Orange Book record can be matched for APHEXDA from the input alone.
Who are the CMO and fill-finish suppliers for APHEXDA manufacturing?
Featured snippet answer: Cannot be provided without knowing APHEXDA dosage form and the labeled manufacturing sites.
What data is typically used to build a CMO map?
- Labeling section listing manufacturing sites
- FDA inspectional observations tying site names to processes
- Batch/lot release references (when disclosed)
- Contract manufacturing statements in regulatory submissions
None of these can be associated with APHEXDA from the input provided.
How does APHEXDA’s supply chain change during shortages or post-launch scale-up?
Featured snippet answer: Not determinable from the provided input.
What signals indicate supplier shifts?
- Label updates showing new manufacturing sites
- Transfers of manufacturing authorization
- DMF amendments adding new synthesis routes
- FDA shortage notifications naming facilities and quantities
No shortage or facility-level data is provided for APHEXDA.
Which suppliers matter most for API availability and cost risk for APHEXDA?
Featured snippet answer: Cannot be stated without the API identity and its known manufacturing footprint.
API concentration risk factors
Supplier exposure often depends on:
- Number of approved API sources
- DMF concentration (one-to-few-file situations)
- Custom synthesis complexity
- Regulatory barriers for facility changeovers
No API identity is provided.
Key Takeaways
- A supplier list for “APHEXDA” cannot be produced from the provided information without risking inaccuracy.
- Supplier-grade identification requires product identifiers (drug substance identity, dosage form, NDC/Orange Book match) that are not present in the input.
FAQs
- How can I identify the actual manufacturing site for a marketed drug in the US? Use NDC Directory labeler/manufacturer fields and match to FDA labeling and inspectional records for the exact dosage form.
- Does Orange Book show the API supplier? Orange Book primarily lists patents and listed drug details; API suppliers are typically inferred or confirmed via DMF/CTD references and labeling manufacturing site fields.
- What sources reliably name CMOs for a drug product? FDA label manufacturing sections, site-specific inspection records, and the drug application review documents that reference manufacturing responsibilities.
- How do supplier changes show up after approval? Commonly through labeling updates reflecting new manufacturing sites, DMF amendments, and supplemental submissions that add or replace sites.
- What triggers major APD (active pharmaceutical ingredient) supply risk? Limited approved API sources, complex synthetic steps, and regulatory constraints on site changes.
References
No sources are cited because no verifiable APHEXDA identifiers or FDA-linked records were provided in the prompt.
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