Suppliers and packagers for XELODA

XELODA

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Cheplapharm	XELODA	capecitabine	TABLET;ORAL	020896	NDA	H2-Pharma, LLC	61269-475-12	120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (61269-475-12)	1998-04-30

XELODA (capecitabine) suppliers: Who manufactures capecitabine API and finished tablets, and what supply-chain/IP risks matter

Last updated: May 24, 2026

XELODA is the brand of capecitabine (oral fluoropyrimidine, prodrug of 5-fluorouracil) marketed by Hoffmann-La Roche. The practical supplier question for XELODA supply-chain planning splits into two layers: (1) capecitabine API manufacturers and (2) finished-dose tablet suppliers and packagers used by Roche and by licensed generic/authorized distributors. Publicly identifiable supplier lists depend on market (US vs EU vs LATAM), product form (tablets strength), and whether you are sourcing brand product through Roche distribution or sourcing generics through tendered channels.

Who supplies XELODA in the US and what companies are typically in the capecitabine supply chain?

Featured-snippet level answer: XELODA in the US is distributed under Roche branding; the finished-dose manufacturing and packaging is handled by Roche’s contract manufacturing network. The supply chain upstream is capecitabine API, sourced from specialized chemical manufacturers that also supply multiple generic makers.

How does the supplier landscape differ between brand distribution and manufacturing?

• Brand distribution: Roche commercial organization and contract distributors.
• Manufacturing/packing: Roche uses CDMOs/contract manufacturers for finished-dose production and packaging (site-level depends on strength and lot).
• API: capecitabine API is produced by fine-chemical/pharmaceutical intermediates suppliers, then shipped to finished-dose manufacturers.

Which supplier categories matter most for procurement?

• API sourcing continuity (single- vs multi-source)
• API quality compliance (DMF/ASMF coverage for FDA, CEP for EU)
• Finished-dose CGMP track record and packaging capability
• Counterfeit diversion controls in cross-border sourcing
• Ability to support tender volume ramp-up within lead-time constraints

Which companies make capecitabine API that can feed XELODA and generics?

Capecitabine is a mature generic active. As a result, the API supplier universe is broader than for newer molecular entities, with multiple chemical manufacturers capable of supplying global markets. In practice, XELODA brand product relies on Roche’s selected qualification set, while generic firms rely on one or more API supply partners with relevant regulatory filings.

Typical API-supplier structure for mature oncology oral drugs

• Core API producer: produces capecitabine bulk API (often via multi-step synthesis with validated impurity controls).
• Intermediates suppliers: produce key intermediates that are later incorporated in the API route.
• Finished-dose manufacturer: performs tablet manufacture and packaging once it has qualified API.

What to look for when mapping API suppliers for capecitabine

• Regulatory status of the API (FDA DMF or ASMF references and update cadence)
• Observed quality performance (OOS/recalls are typically published for the finished-dose entity, but supply interruptions often trace back to API constraints)
• Geographic footprint (US/EU shipment lanes for batch release timelines)

What finished-dose manufacturers supply capecitabine tablets (XELODA strength) for brand and authorized channels?

Finished-dose tablet suppliers for capecitabine are usually identified through the drug’s labeling, FDA product listings, and lot-level packaging information. For XELODA, Roche’s finished-dose supply chain uses qualified manufacturing sites. Generic and authorized distributors often use different tablet sites and packaging configurations even when the API is the same.

How do you identify finished-dose supplier sites that matter for contracting?

• Labeling/packaging imprint: manufacturing and packaging site codes can change by lot.
• Submission references: ANDA filings include manufacturer and packager roles; brand formulations are not always identically mirrored in ANDA content, but it gives visibility into market capacity.
• Tender documentation: distributors typically provide manufacturer-of-record and packaging details at qualification.

What are the regulatory and documentation hooks that tie suppliers to XELODA supply?

The supplier mapping for regulated procurement is driven less by “who can make capecitabine” and more by “who is on file” with regulators.

US hooks (FDA)

• DMF/ASMF linkages for API used in marketed products
• CGMP inspections and regulatory correspondence affecting supplier eligibility
• Batch release and distribution controls for finished-dose tablets

EU hooks (EMA/HMA)

• CEP coverage, ASMF references where used
• QP release regime for EU market batches
• GMP certification of manufacturing and packaging sites

What generic or biosimilar suppliers compete with XELODA and how does that change the supply picture?

Capecitabine is chemically synthesized, so the competitive dynamic is generic tablets, not biosimilars. Generic supply is driven by the availability of qualified API and the ability to meet dissolution, impurity, and bioequivalence requirements.

What generic entry risks affect supplier continuity?

• Single-source API dependencies leading to shortages
• Quality deviations that trigger batch holds
• Regulatory delays in supplier qualification updates
• Capacity constraints during oncology tender cycles

How does XELODA supply compare with capecitabine generics by manufacturer risk?

For mature drugs, supplier risk tends to concentrate around capacity cycles and API availability rather than unique formulation complexity.

Comparison framework for procurement teams

• Brand product: fewer manufacturing sites but stable qualification history
• Generic product: broader manufacturer set but higher variability in batch release performance and impurity profiles across sites

What formulation and strength considerations change who can supply XELODA tablets?

XELODA is supplied as oral tablets of specific strengths (commonly 150 mg and 500 mg in many markets). Strength-specific manufacturing and packaging can shift when Roche changes manufacturing lots or uses alternate sites.

What to check at the strength and package level

• Tablet imprint codes (site identifiers)
• Packaging configuration (bottles/blisters by market)
• Storage conditions that can affect logistics and returns

Key Takeaways

• XELODA supply chains run through Roche’s qualified contract manufacturing and packaging network, backed by qualified capecitabine API producers.
• Supplier identification in regulated procurement should be based on regulatory hooks (DMF/ASMF and CGMP-eligible sites) and lot-level labeling, not generic “capecitabine maker” lists.
• For capecitabine, generic competition is about tablet manufacturing capacity and API continuity, not biosimilar pathways.
• Strength-specific manufacturing and packaging can vary by lot, so contract qualification should include packaging-site and tablet-site verification.

FAQs

1. How do I identify the manufacturer-of-record for XELODA bottles by lot?
   Check the lot-specific labeling/pack insert for the manufacturer and packaging site identifiers printed on the bottle and carton.

2. Are there different capecitabine API suppliers for the 150 mg vs 500 mg XELODA strengths?
   Typically the API molecule is the same, but supplier selection can vary by regulatory qualification for the finished-dose strength and packaging site.

3. What causes capecitabine tablet shortages when multiple generic versions are available?
   Supply constraints usually trace to qualified API availability, finished-dose capacity, or regulatory batch release holds rather than to consumer demand alone.

4. Do authorized generic programs use the same tablet manufacturers as the brand?
   Often not. Authorized or generic makers may use different finished-dose sites while sourcing API from one or more shared qualified producers.

5. What documentation is most important to qualify a capecitabine supplier for pharma procurement?
   GMP status of the API and finished-dose sites, regulatory filing coverage (DMF/ASMF references), and evidence of batch release performance and deviation history.

References

1. FDA. “Drugs@FDA: XELODA.” U.S. Food and Drug Administration.
2. FDA. “Drug Shortages: Capecitabine and related products.” U.S. Food and Drug Administration.
3. Roche. XELODA prescribing information and labeling documentation (US). Hoffmann-La Roche.