Suppliers and packagers for ELYXYB

ELYXYB

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Scilex Pharms	ELYXYB	celecoxib	SOLUTION;ORAL	212157	NDA	SCILEX PHARMACEUTICALS INC.	69557-333-01	6 BOTTLE in 1 CARTON (69557-333-01) / 4.8 mL in 1 BOTTLE	2023-11-27
Scilex Pharms	ELYXYB	celecoxib	SOLUTION;ORAL	212157	NDA	SCILEX PHARMACEUTICALS INC.	69557-333-02	1 BOTTLE in 1 CARTON (69557-333-02) / 4.8 mL in 1 BOTTLE	2023-11-27

Suppliers for ELYXYB (celecoxib) in the US Supply Chain: API, Finished Dose, and Contract Manufacturing Map

Last updated: May 26, 2026

Executive summary: ELYXYB is a celecoxib product (brand by Pfizer). The company’s sourcing and manufacturing footprint for US supply is split across: (1) celecoxib active pharmaceutical ingredient (API) procurement, (2) contract manufacturing for finished-dose ELYXYB capsules/tablets, and (3) packaging and distribution partners used under cGMP commercial supply. Without ELYXYB’s FDA application-to-supply chain mapping (e.g., the specific Drug Master File references for API, and the exact manufacturer/processor/packager names tied to each labeled strength and dosage form), a complete supplier list cannot be compiled to a litigation-grade standard.

Who supplies the celecoxib API for ELYXYB?

Answer: ELYXYB’s API supplier is the company named in FDA records for the celecoxib API used in ELYXYB’s approved manufacturing process. In practice, this is identified through the application’s manufacturing section and any referenced DMF(s) for celecoxib API, plus the API manufacturer names shown in the FDA submission and/or relevant inspection histories.

What names typically appear for celecoxib API

For celecoxib, API supply in the market commonly comes from global chemical manufacturers that hold:

• DMFs for celecoxib (or supplier master files)
• cGMP manufacturing slots for polymorph-controlled or impurity-specified celecoxib lots
• document pathways supporting end-product release and stability

What to look for to identify the exact API supplier for ELYXYB

To identify the ELYXYB API supplier with precision, records usually show:

• API manufacturer listed in the ELYXYB application
• DMF holder name(s) referenced for API
• importer/manufacturing site information used for commercial release

Which contract manufacturers produce ELYXYB finished dose in the US?

Answer: ELYXYB finished-dose manufacturing is performed by the manufacturer listed for the dosage form in the FDA application, with site-specific cGMP responsibilities for drug product manufacturing and (often) packaging.

Dosage form and site dependencies

“ELYXYB” is marketed as a celecoxib formulation; supplier mapping changes by:

• strength (mg)
• dosage form (capsule vs tablet, if applicable)
• packaging configuration (bottle vs blister)
• label revisions that alter the manufacturing site or packager

What to extract from regulatory and inspection data

A litigation-grade supplier list for finished dose generally requires:

• labeled drug product manufacturing site(s)
• labeled packager/labeler site(s)
• any secondary manufacturing steps (e.g., blending, encapsulation, tableting, coating)

Who are ELYXYB’s packaging and labeling suppliers?

Answer: Packaging and labeling for ELYXYB is performed by the packager(s) named on regulatory records tied to commercial distribution.

How packaging suppliers get identified

Packaging sites can be identified by:

• “manufactured for” and “distributed by” label sections
• FDA manufacturing and labeling listings (site-by-site)
• inspection assignments for packaging operations

What does the ELYXYB supply chain look like across API, drug product, and packaging?

Answer: A typical mapped flow is:

1. celecoxib API is sourced from an API manufacturer (often under DMF coverage)
2. API is formulated with excipients and processed into finished ELYXYB dosage form at a drug product manufacturer site
3. finished dose is packaged and labeled at a packager site (which may be the same as the drug product site or different)
4. distribution is coordinated under the brand owner’s logistics framework

How do you verify ELYXYB suppliers in FDA and public records?

Answer: Verification depends on finding the exact manufacturer/processor/packager names tied to the approved NDA for ELYXYB.

Record types used

Supplier verification usually relies on:

• FDA application manufacturing sections for the NDA
• FDA’s “Orange Book” listing supporting drug product manufacturing references (where applicable)
• FDA inspection and enforcement actions naming specific sites for manufacturing steps

What can change supplier identity

Supplier lists shift due to:

• site transfers during CMC changes
• packaging line changes (packager swap)
• additional manufacturing sites added for redundancy or capacity expansion

Are there multiple ELYXYB suppliers by strength or dosage form?

Answer: In commercial supply, multiple sites are common when there are:

• different strengths produced by different lines
• separate packaging configurations
• parallel manufacturing capacity for continuity

Which suppliers are most relevant for generic or biosimilar risk around ELYXYB?

Answer: Supplier concentration matters for generic entry because abbreviated approval pathways still require:

• demonstration of sameness to the reference listed drug (RLD)
• validated manufacturing methods and control strategies

If ELYXYB has a tightly controlled formulation or manufacturing method, the most relevant “barrier” suppliers are those owning:

• API and key excipient control strategies
• drug product manufacturing process know-how
• packaging configuration and stability control

How strong is ELYXYB’s sourcing resilience if a supplier is disrupted?

Answer: Resilience depends on whether ELYXYB is made and packaged across multiple approved manufacturing sites. The presence of multiple labeled sites reduces single-point failure risk.

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Key Takeaways

• ELYXYB supplier identification requires the exact FDA-linked manufacturer and site names for API, finished dose, and packaging.
• A complete supplier list cannot be produced here without the specific regulatory manufacturing listings tied to ELYXYB’s approved NDA (including any API DMF references and drug product/packager sites).
• In the US market, the supplier map typically spans: API manufacturer (often DMF-backed), drug product manufacturer (cGMP formulation and processing), and packaging/labeling site(s).

FAQs

1. How can I identify the exact celecoxib API manufacturer used for ELYXYB?
2. Do ELYXYB strengths use different manufacturing sites?
3. Who are the packagers for ELYXYB bottle vs blister packaging?
4. What FDA records list the drug product and packager sites for ELYXYB?
5. How does manufacturing-site redundancy affect ELYXYB supply continuity during disruptions?

References

1. FDA Orange Book (Drug Products). U.S. Food and Drug Administration.
2. FDA Drug Applications and Manufacturing/Inspection Records. U.S. Food and Drug Administration.
3. Approved NDA Manufacturing and Labeling Information (public FDA submissions). U.S. Food and Drug Administration.