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Suppliers and packagers for XIFYRM
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XIFYRM
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Azurity | XIFYRM | meloxicam | SOLUTION;INTRAVENOUS | 218395 | NDA | Azurity Pharmaceuticals, Inc. | 24338-153-02 | 10 VIAL, SINGLE-DOSE in 1 CARTON (24338-153-02) / 1 mL in 1 VIAL, SINGLE-DOSE (24338-153-01) | 2025-06-05 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for XIFYRM
XIFYRM Supplier Landscape (API, Finished Dose, and Key Manufacturing Partners)
Executive summary: XIFYRM supplier information cannot be provided because the drug identity, active ingredient(s), and specific dosage form(s) behind the name “XIFYRM” are not determined from the request. Without the correct product mapping to an FDA-listed drug (including strength and dosage form) or a distinct marketed product in the relevant jurisdiction, no authoritative list of API or finished-dose suppliers can be produced.
What company makes XIFYRM (API and finished-dose suppliers)?
No supplier mapping can be issued for “XIFYRM” because the product’s active ingredient and dosage form are not established. Supplier identification depends on the exact reference product (e.g., FDA NDA/BLA, strength, dosage form, manufacturer of record, and labeler/holder data).
How do you identify XIFYRM’s manufacturing entities by labeler and NDA holder?
Supplier lists for a specific branded drug are typically derived from:
- FDA Orange Book listing (drug substance and drug product manufacturers)
- FDA NDC Directory (labeler and marketed product details)
- SPL label data (manufacturer of record by dosage form)
- Patent-related assignments (manufacturing-use correlations are indirect)
No such linkage to XIFYRM is possible from the current input.
What are the main XIFYRM contract manufacturing organizations (CMOs)?
No CMO identification can be produced because XIFYRM’s regulatory product identity is not defined. CMO identification requires a confirmed link to:
- NDA/BLA submission data
- label “Manufactured for” or “Distributed by” fields
- inspections or establishment lists by firm for the correct product
Who supplies the active pharmaceutical ingredient for XIFYRM?
No API supplier list can be provided. API sourcing is specific to:
- the drug substance (active ingredient identity)
- the salt/polymorph/hydrate form (when applicable)
- the approved manufacturing site(s) listed in regulatory filings
Without the validated active ingredient for XIFYRM, the supplier universe cannot be determined.
What patents or licenses govern XIFYRM supply chain partners?
No patent or license-driven supplier constraints can be mapped without knowing:
- the exact active ingredient and formulation
- the relevant patent estate
- any exclusivity or licensing agreements tied to the supply chain
What generic or biosimilar suppliers compete with XIFYRM?
No competitor supplier set can be generated. Competitive supply typically requires:
- FDA approval history and ANDA/BLA landscape
- Orange Book patent challenges
- settlement agreements that affect entry timing and manufacturing pathways
None can be tied to XIFYRM from the prompt alone.
Orange Book status of XIFYRM: which suppliers are listed for manufacture?
No Orange Book status can be reported. Orange Book listings require a specific NDA number or precise match to an FDA reference listed drug. The prompt does not establish that match.
When does XIFYRM lose exclusivity, and how does that change suppliers?
No exclusivity timeline can be issued because XIFYRM’s reference product and patent terms are not identified.
Which XIFYRM formulation strengths have different manufacturing sites?
No strength-by-strength manufacturing map can be produced. Site splits are common across:
- immediate-release vs extended-release
- different strengths
- different dosage forms
- packaging configurations
Those require the verified product catalog entry.
How many manufacturing establishments support XIFYRM in the US market?
No establishment count can be provided without confirmed FDA listing(s) for the product.
What procurement risks exist for XIFYRM supply (single-source API, CMO concentration)?
No procurement risk assessment is possible because supply chain structure is not identifiable from the request.
Key Takeaways
- Supplier identification for “XIFYRM” cannot be completed without a validated mapping to the specific marketed drug product (active ingredient, strength, dosage form, and regulatory identifier).
- No API suppliers, CMOs, or finished-dose manufacturers can be listed based on the current input.
FAQs
- How do I find the API supplier for a branded drug with the FDA labeler name?
- What document shows the manufacturer of record for an NDA drug product?
- How can Orange Book listings be used to identify which firms manufacture the drug product?
- What role do CMO and contract sterilization providers play in dosage-form supply?
- How do patent challenges (Paragraph IV) affect supply chain licensing for generics?
References (APA)
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA. https://www.accessdata.fda.gov/scripts/cder/ob/
- U.S. Food and Drug Administration. NDC Directory. FDA. https://www.fda.gov/drugs/drug-product-availability-and-review-systems/ndc-directory
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