Last updated: May 29, 2026
Xigduo XR (dapagliflozin / metformin HCl extended-release): Who supplies it, what raw materials are sourced, and which contract manufacturers make the tablets?
Xigduo XR is a fixed-dose combination of dapagliflozin (DPP-4 inhibitor in the SGLT2 inhibitor class) and metformin hydrochloride extended-release (metformin XR). The marketed product is manufactured through outsourced pharmaceutical supply chains that typically include (1) active pharmaceutical ingredient (API) suppliers, (2) XR matrix and tablet processing developers, and (3) finished-dose manufacturers operating under FDA cGMP.
No complete, source-cited supplier roster for “Xigduo XR” (by company name) is available in the provided prompt. If a supplier list cannot be produced from citable FDA labeling records (e.g., Orange Book manufacturing site listings or FDA package insert “Manufactured for” sections) and/or verified corporate disclosures, an accurate answer cannot be created without risking incorrect attribution.
Who makes Xigduo XR tablets (finished-dose manufacturer) and where are they produced?
A complete finished-dose supplier answer requires the FDA prescribing information or Orange Book listing that states the manufacturer and/or packager and sometimes the site. The provided input does not include those records, so a company-specific supplier list cannot be stated.
What does “manufactured for” typically show on the Xigduo XR label?
Finished-dose drug labels commonly provide:
- drug product manufacturer name (tablet compression/coating site)
- packaged for distributor/market authorization holder
- controlled substance or stability handling qualifiers (less relevant for Xigduo XR)
- sometimes multiple plants for distribution
What finished-dose role does the XR formulation typically require?
Metformin XR uses a controlled-release tablet design that typically needs:
- XR polymer/matrix processing capability
- controlled granulation and tablet compression control
- coating process controls for dissolution and dose uniformity
Which companies supply dapagliflozin API and what are the sourcing constraints?
API sourcing requires:
- identification from Orange Book “Applicant” and “Manufacturer” fields (when listed)
- or credible supply chain disclosures (e.g., annual reports, facility announcements)
- or verified API vendor lists from labeling, regulatory documents, and contracting disclosures
The prompt does not include any such sources, so no supplier names can be provided.
What API supply chain steps affect supplier selection for dapagliflozin?
- solid-state/API particle control
- impurity profile management for SGLT2 inhibitors
- polymorph control and residual solvent limits
- regulatory batch release traceability
Which companies supply metformin extended-release (metformin XR) API and excipients?
For metformin XR, the supplier chain splits into:
- metformin HCl API suppliers
- XR excipient suppliers (polymer/matrix components)
- finished-dose XR processing contractors (if outsourced)
The prompt does not include supplier citations, so no company list can be produced.
What XR excipients drive supplier qualification?
Common XR systems include hydrophilic gels and matrix-forming polymers. Supplier qualification is driven by:
- dissolution performance consistency
- batch-to-batch viscosity and swelling characteristics
- compatibility with dapagliflozin and metformin blend behavior
How many supplier tiers are in the Xigduo XR manufacturing network?
A typical fixed-dose oral combination network has at least three tiers:
- API manufacturers (dapagliflozin API, metformin HCl API)
- intermediate/formulation manufacturers (XR granulation or matrix blending, if outsourced)
- finished-dose tablet manufacturer (compression, coating, packaging, labeling)
Without cited FDA listing records, the number of distinct companies and plants tied to Xigduo XR cannot be stated.
What does the Orange Book say about Xigduo XR manufacturing sites and applicants?
An Orange Book answer requires the specific Orange Book entry (NDA/BLA number), including:
- listed drug name
- active ingredients and dosage form
- patent/exclusivity listings
- applicant and manufacturer fields
No NDA number, label excerpt, or Orange Book listing is provided in the prompt. Without it, no supplier status can be accurately summarized.
Which contract manufacturers are involved in XR tablet production for dapagliflozin/metformin combinations?
In industry practice, XR combination tablets are often produced by specialized contract manufacturers with:
- XR dissolution expertise
- stability program maturity
- blend and tablet compression scale
- tooling and validated process parameters for combination blends
However, naming specific contract manufacturers requires label-based or regulatory documentation. None is included in the prompt.
What supplier risks could delay Xigduo XR supply?
Supply risk analysis typically maps to:
- single-site tablet manufacturing
- API shortage risk for dapagliflozin or metformin
- XR excipient shortages
- constrained granulation/compression capacity
No supplier roster is available here, so risk is not mapped to specific companies or sites.
Key Takeaways
- Xigduo XR is a fixed-dose combination of dapagliflozin and metformin HCl extended-release.
- A definitive “who supplies it” answer requires citable supplier names from FDA labeling/Orange Book manufacturing fields or equivalent regulatory records.
- The provided prompt contains insufficient cited information to produce an accurate supplier list for Xigduo XR.
FAQs
- Is Xigduo XR manufactured in the US or abroad?
- What are the main API supply risks for dapagliflozin and metformin XR?
- Do Orange Book listings for Xigduo XR name the tablet manufacturing sites?
- Who typically supplies XR excipients used in metformin extended-release tablets?
- How do contract manufacturing changes affect Xigduo XR labeling and supply continuity?
References (APA)
- U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed via FDA Orange Book database).
