Last updated: May 25, 2026
FARXIGA Suppliers: Who Manufactures, Supplies, and Contracts for Dapagliflozin Tablets (US and Global)
FARXIGA (dapagliflozin) is supplied through a multi-tier manufacturing network spanning active pharmaceutical ingredient (API) production, formulation and tablet manufacturing, and secondary packaging under AstraZeneca’s global supply chain. The supplier roster is typically reflected in FDA labeling/manufacturing disclosures and regulatory submissions, with additional manufacturer-of-record details appearing on the US label and on product listings tied to specific dosage forms and strengths.
Core manufacturing inputs for FARXIGA
- Drug substance (API): dapagliflozin (produced by designated API sites under AstraZeneca and/or contracted API manufacturers).
- Drug product: immediate-release oral tablets in multiple strengths (10 mg and 5 mg).
- Secondary packaging: bottle/carton packaging operations at labeled packaging sites.
- Quality system: GMP compliance across API and finished dose steps, with site-specific manufacturing authorization for the marketed strengths.
Who are the FARXIGA drug product and packaging manufacturers (FDA label “manufactured for” and NDC listings)?
The highest-reliability “supplier” identifiers for FARXIGA are the entities named on the US product label and in FDA-maintained product listings for each NDC and dosage strength. These disclose the finished dosage manufacturer(s) and sometimes the packager(s).
How to map suppliers to specific FARXIGA tablet strengths
FARXIGA is marketed as:
- 5 mg tablets
- 10 mg tablets
Each strength can have different NDCs and can be associated with different manufacturing and packaging sites, even when the marketing authorization holder is the same.
What to look for on the labeling
For each FARXIGA NDC/strength, supplier capture should focus on:
- “Manufactured for” or “Manufactured by” statements
- Site addresses listed under manufacturing/packaging sections
- The label sponsor and any contract-manufacturer names tied to GMP release
Which companies supply the FARXIGA API (dapagliflozin drug substance)
DAPAGLIFLOZIN API supply typically comes from:
- Contract API manufacturers for the commercial drug substance
- AstraZeneca-owned or contracted chemistry sites
In regulated supply chains, API supplier identification is most concrete when captured from:
- FDA drug substance manufacturing disclosures (where available in regulatory filings)
- Inspection disclosures (FDA establishment inspections)
- Labeling and internal supply chain references linked to ANDA/DMF linkages for competitors
What is the FARXIGA manufacturing network structure (API to tablets to packaging)?
A practical supplier map for FARXIGA looks like a chain:
- API synthesis
- Creation of dapagliflozin and intermediate purification
- Drug substance conditioning
- Solvent swaps, drying, blending, QA release to formulation
- Tablet formulation and compression
- Granulation or direct compression steps depending on process
- Coating (if applicable)
- Tablet coating operations if the marketed presentation includes coatings
- Packaging
- Bottling/cartoning and label printing under GMP controls
- Distribution and batch release
- QA batch disposition to US distribution channels
Supplier control points typically include:
- Incoming raw material qualification
- Process validation on formulation and tablet press steps
- Stability programs for shelf life
- Cold chain is not generally applicable for FARXIGA tablets, so the key logistics constraint is GMP warehousing and temperature excursions monitoring.
Are there multiple FARXIGA suppliers across geographies (US vs EU vs other markets)?
Yes. Commercial pharmaceutical supply chains for blockbuster oral drugs commonly use:
- Parallel manufacturing sites across regions
- Redundancy for continuity of supply
- Site substitution via regulatory notifications for certain changes
For FARXIGA, geography-specific suppliers are best evidenced by:
- Regional product leaflets/SmPC and local labeling
- EU manufacturing authorization listings
- FDA label/manufacturing statements tied to each US NDC
Which contract manufacturers make FARXIGA tablets and bottles?
Contract-manufacturer involvement depends on the specific manufacturing and packaging operations tied to each NDC. The contract role is inferred from labeling “manufactured for” lines and the presence of site addresses.
Commercially important distinctions:
- Finished-dose contract manufacturers hold the tablet manufacturing license for a labeled site.
- Packaging contract manufacturers hold packaging/distribution center obligations for labeled NDCs.
In practice, FARXIGA supplier due diligence for procurement or litigation use should be NDC-specific rather than assuming a single universal manufacturer for all lots.
How many suppliers does FARXIGA use for each step (API, tablet, packaging)?
For high-volume oral solids, the typical pattern is:
- API: at least one primary plus one alternate/backup supplier site
- Drug product: one primary tablet site plus alternate production/packaging sites
- Packaging: multiple packaging lines can feed regional bottling requirements
To quantify the exact number for FARXIGA, supplier counts must be compiled from:
- All FARXIGA NDCs across strengths
- The “manufacturer” and “packager” names listed per NDC
What supplier changes and site notifications affect FARXIGA availability?
Site changes impacting suppliers usually come from:
- Manufacturing process scale changes
- Facility renovations
- Equipment replacements
- Packaging line reconfigurations
- Batch record updates
These changes generally require:
- Regulatory notification/approval pathways depending on jurisdiction and change type
- Updated quality documentation and stability commitment
For FARXIGA oral solids, the availability risk generally comes from:
- Loss of GMP-ready capacity at a tablet or packaging site
- Raw material supply disruptions for dapagliflozin intermediates or excipients
- Quality events requiring batch holds and re-release
What generic and biosimilar challenges matter for FARXIGA supplier continuity?
FARXIGA faces generic entry risk in jurisdictions where patents and exclusivity permit. Even without naming biosimilars (dapagliflozin is a small molecule), generic competition affects supplier strategy:
- Contract manufacturers can add non-AstraZeneca capacity
- AstraZeneca may shift production among sites to protect supply or manage demand
- API sourcing diversification becomes more important as commercial volumes and margins change
Supplier risk lens for generic ramps
- API supply switching can be gated by qualification and validation timelines.
- Tablet manufacturing site transition can create temporary batch stability and QC challenges.
- Packaging line capacity becomes a bottleneck if multiple branded and generic NDCs share contracted lines.
Which excipient and raw-material suppliers support FARXIGA tablets (procurement view)?
For oral solids, excipient suppliers typically include:
- Cellulose-based diluents/disintegrants
- Binders and lubricants
- Colorants (if any) and coating components (if applicable)
- Packaging materials: HDPE bottles, caps/liners, desiccants where used, carton materials
Supplier identification at excipient level is rarely complete from public sources, but procurement due diligence typically focuses on:
- DMF status and regulatory standing of excipient grades
- Supplier quality audits and CoA traceability
- Supply continuity of critical excipients
How to build a FARXIGA supplier list for licensing, litigation, or procurement
A defensible supplier list usually combines:
- FDA label/manufacturing disclosure capture by NDC and strength
- API supplier identification through regulatory and inspection-linked evidence
- Batch release and lot traceability records where legally accessible
- Contract manufacturing agreements (if available via discovery in litigation)
Deliverable structure for business use
- Table: NDC, strength, dosage form, labeled manufacturer, labeled packager, site address, and change history
- Table: API supplier(s) and associated DMF/inspection references where available
- Risk table: single-site dependencies, stability constraints, and alternates
Key Takeaways
- FARXIGA supply is organized around API production, tablet manufacturing, and packaging under GMP, with supplier names tied to strength-specific NDCs.
- The most actionable “supplier truth” for FARXIGA is the US label’s manufacturer and packager statements at each NDC/strength.
- Contract manufacturing and multi-site redundancy are typical for an oral solid blockbuster; supplier mapping should be NDC-specific, not “one supplier per brand.”
FAQs
- Which manufacturers are listed on the FARXIGA 5 mg tablet label for “manufactured for” and “packed by”?
- Does FARXIGA use different manufacturing sites for the 5 mg and 10 mg strengths (by NDC)?
- Who supplies dapagliflozin API for FARXIGA (drug substance supplier names)?
- How do packaging suppliers impact FARXIGA continuity of supply during shortages?
- What procurement red flags exist if FARXIGA relies on a single tablet manufacturing or bottling site?
References
- US Food and Drug Administration. Orange Book, Approved Drug Products and Associated Patents. (Search).
- US Food and Drug Administration. Drug Labels and Medication Guides for FARXIGA (dapagliflozin). (Search).
- FDA. NDC Directory and drug product listings for FARXIGA (dapagliflozin). (Search).
