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Suppliers and packagers for ELIQUIS SPRINKLE
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ELIQUIS SPRINKLE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Bristol | ELIQUIS SPRINKLE | apixaban | FOR SUSPENSION;ORAL | 220073 | NDA | E.R. Squibb & Sons, L.L.C. | 0003-0898-28 | 28 CAPSULE in 1 BOTTLE (0003-0898-28) | 2025-09-15 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
ELIQUIS SPRINKLE Suppliers (Apixaban) for Rx Drug Product, Active Ingredient, and Key Packaging
ELIQUIS SPRINKLE (apixaban oral granules) is supplied as a branded oral drug product with an FDA-approved manufacturing supply chain that is anchored in the Janssen/Bristol Myers Squibb (BMS) commercial organization and its approved contract manufacturers listed across FDA drug-approval documentation and in the Orange Book manufacturing section for the listed NDA.
Who manufactures ELIQUIS SPRINKLE (apixaban) granules and what are the supplier bottlenecks?
Answer: ELIQUIS SPRINKLE is manufactured under the NDA by approved manufacturing sites used by the NDA holder (BMS) and listed in FDA approval records and product labeling/Orange Book manufacturing sections. Bottlenecks typically concentrate in (1) granulation and packaging for pediatric dosing granules, (2) apixaban API conversion and blending, and (3) validated cold-chain or humidity-controlled warehousing for finished packs depending on storage conditions stated for the product.
What contract manufacturers typically handle for ELIQUIS SPRINKLE
Granule drug products usually require dedicated upstream and downstream steps that drive supplier eligibility:
- API receipt and controlled blending for dose uniformity
- Granulation and drying under validated moisture specs
- Sieving and particle-size control to maintain dispersion consistency
- Unit-dose packaging format specific to pediatric administration
- Stability program support for lot release and shelf-life maintenance
Where do suppliers appear in FDA-facing documents?
For an FDA-approved drug product, supplier identification is typically visible in:
- Orange Book “Manufacturing Site(s)” for the specific drug product listing
- Drug product labeling “Manufactured by” / “Distributed by” sections
- NDA Chemistry, Manufacturing and Controls (CMC) summaries embedded in approval packages
- Inspections and site listings tied to NDA manufacturing authorizations
Which companies supply apixaban API used to make ELIQUIS SPRINKLE?
Answer: Apixaban API supply is typically sourced from specialized API manufacturers with DMF or API section of the NDA; the NDA holder uses multiple qualified suppliers, with approval tied to process validation and impurity specifications.
Common supplier model for apixaban APIs (industry structure)
Even when API suppliers vary over time, the eligibility logic is consistent:
- API is manufactured to the NDA-approved specifications
- Impurity profile and residual solvent limits are controlled to match the finished drug’s release specs
- Change controls and CMC supplements govern supplier substitution
- Some suppliers may provide intermediates or finished API under quality agreements
What to look for to identify exact API suppliers
Exact API supplier names for apixaban are generally confirmed via:
- Orange Book listing tied to the NDA (where manufacturing is shown, sometimes only at drug-product level)
- DMF reference (by number) in FDA CMC documentation for apixaban
- Labeling and NDA manufacturing site sections, which sometimes do not name API vendors directly
What packaging suppliers support ELIQUIS SPRINKLE dosing administration?
Answer: Packaging suppliers for granules are usually co-located with drug-product packaging lines or provided via qualified packaging component vendors. The critical supplier constraint is maintaining moisture barrier and correct unit-dose/dispensing format.
What packaging supply elements matter
- Primary pack integrity (often moisture barrier)
- Unit-dose count accuracy and tamper evidence
- Labeling serialization where used by distribution partners
- Secondary packaging components for wholesale distribution
How to map packaging suppliers in practice
Packaging supplier names tend not to appear in public-facing Orange Book entries at component-vendor granularity. They usually show up through:
- labeling “packaged by” statements
- inspection databases and CMC supplement records
- internal quality agreements between BMS and packaging partners
What is the Orange Book status for ELIQUIS SPRINKLE and how does it tie to supplier eligibility?
Answer: Orange Book listings for ELIQUIS (apixaban) show approved drug products and their NDA linkages. Manufacturing-site entries in the Orange Book drive who is legally eligible to produce the marketed product.
How Orange Book entries are used by sourcing teams
Commercial sourcing and regulatory compliance teams use:
- NDA and drug product listing identifiers
- Manufacturing-site names and addresses listed for each strength/dosage form
- Applicant or NDA holder identity and marketing authorization
What generic or authorized-supply risks exist for ELIQUIS SPRINKLE sourcing?
Answer: Supplier risk is less about product-level exclusivity and more about manufacturing capacity, site compliance, and raw material continuity. For a branded pediatric formulation, the main disruption channels are:
- contract manufacturing line downtime
- API supply interruptions
- packaging component shortages
- regulatory hold or corrective action tied to GMP findings
How launches and litigation affect supply
Even when a supplier can manufacture, marketing and supply may be constrained by:
- labeling changes tied to post-approval manufacturing supplements
- batch release delays during quality system remediation
- settlement or injunction outcomes in product disputes (less common for a branded formulation unless there is a challenge to the product)
Which suppliers matter most for volume continuity?
Answer: The suppliers that matter most for continuity are the approved manufacturer sites and the API suppliers referenced in the NDA/DMF systems. For ELIQUIS SPRINKLE, that typically means:
- the NDA-approved granule manufacturing and packaging site(s)
- the qualified apixaban API suppliers (or intermediate suppliers) under DMF/CMC
- the packaging component suppliers meeting moisture barrier specs
Key Takeaways
- ELIQUIS SPRINKLE supply is anchored to the NDA holder’s approved manufacturing sites listed in FDA-facing records (notably Orange Book manufacturing sections for the marketed product).
- API sourcing for apixaban is governed by DMF/CMC-defined specifications, impurity controls, and validated processes; exact vendor identity is confirmed through NDA/DMF-linked FDA documentation.
- Packaging supplier visibility is often indirect in public databases; product-level manufacturing sites and labeling statements are the most reliable public anchors.
- Continuity risk is primarily GMP and capacity-driven: granule/pack line constraints, API continuity, and packaging component availability.
FAQs
-
Where can I find the manufacturing site names for ELIQUIS SPRINKLE?
Look in the FDA Orange Book entry for ELIQUIS (apixaban) corresponding to the granules/sprinkle dosage form; manufacturing site(s) are listed under the NDA drug product. -
Do API suppliers for apixaban appear publicly for ELIQUIS SPRINKLE?
Often not by vendor name at the product-label level; API supplier identity is usually tied to NDA DMFs and CMC approval packages. -
Can multiple manufacturers produce ELIQUIS SPRINKLE?
Yes, but only those manufacturing sites approved in the NDA for that specific dosage form can produce product for the marketed supply chain. -
What causes delays in ELIQUIS SPRINKLE availability?
Typical causes include GMP holds at the manufacturing site, API continuity problems, or packaging component shortages. -
How do contract manufacturing changes affect supply eligibility?
Supplier or site changes require CMC supplements, validation, and regulatory acceptance before commercial distribution continues from the new source.
References
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (ELIQUIS and apixaban listings). https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
- FDA Labeling (ELIQUIS and ELIQUIS SPRINKLE product labeling via Drugs@FDA). https://www.accessdata.fda.gov/scripts/cder/daf/
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