Last updated: May 27, 2026
Executive summary: Synjardy XR (empagliflozin/metformin hydrochloride extended-release) is a combination, solid oral product with a US supply chain tied to the brand’s holder and manufacturing sites listed in FDA records. The two active ingredients are supplied to the finished-dose manufacturer under controlled sourcing, and finished product is typically produced by one or more contract manufacturers at registered FDA facilities. Exact “supplier” attribution depends on whether you mean (1) API suppliers, (2) contract manufacturer(s) for finished tablets, or (3) packaging and secondary-manufacturing vendors, each of which is reflected in different FDA and commercial documentation.
What companies make Synjardy XR tablets in the US supply chain?
Synjardy XR is a fixed-dose combination of:
- Empagliflozin (SGLT2 inhibitor)
- Metformin hydrochloride extended-release (biguanide)
For US market operations, the practical “supplier” set usually breaks into:
- Finished dose manufacturer(s) for tablets (site-level control)
- API manufacturers (active ingredient control)
- Packaging and labeling (secondary manufacturers)
- Distribution partners (wholesalers and logistics, often not tied to product registration)
Where to verify the finished-dose manufacturer: FDA’s product registration and listing records for Synjardy XR identify the manufacturer(s) and related site information that underpins the approved drug product’s commercial supply.
Finished dose manufacturing sites: what matters for sourcing
Key items used in due diligence and licensing diligence:
- FDA registered drug product manufacturer(s) for Synjardy XR (site names)
- Whether manufacturing is done in-house by the NDA holder or by contract manufacturing organizations (CMOs)
- Whether there are multiple sites (reduces disruption risk but complicates IP and supply continuity)
- Batch release location (often differs from manufacturing location)
Which suppliers provide empagliflozin for Synjardy XR?
Empagliflozin sourcing typically comes from the global API supplier ecosystem established around the originator molecule. In practice, API supply for SGLT2 inhibitors can involve:
- Originator-linked or licensed manufacturers of empagliflozin intermediate and API
- Multiple qualified suppliers for redundancy
What you can map to suppliers: FDA drug substance listings and global API documentation are the primary ways to trace API supply. Trade name “supplier” labels in public sources are often incomplete at the API level.
API sourcing constraints that affect availability
- Regulatory qualification of the API supplier and manufacturing process
- Control of particle size, polymorph form, and impurity profile
- Changes requiring comparability and, in some cases, supplemental approval
Which suppliers provide metformin hydrochloride extended-release for Synjardy XR?
Metformin XR has a large manufacturing base globally, with supply split across:
- Metformin API producers
- XR formulation and release-control material suppliers used by the finished-dose manufacturer
- Film-coating, tablet compression, and controlled-release excipient suppliers (site-dependent)
Where metformin XR “supplier” control concentrates: The finished-dose manufacturer’s validated release-control system and excipient strategy are often more determinative of product performance than the broad universe of metformin API producers.
XR formulation supply chain components
Typical control points:
- XR polymer/excipient system that drives release kinetics
- Grade and supplier of excipients (binder, matrix formers, dissolution modifiers)
- Tablet coating materials and colorants (including supply substitution risk)
What contract manufacturing organizations produce Synjardy XR extended-release tablets?
For branded combination products, the NDA holder or marketing authorization holder usually relies on one or more CMOs for:
- Tablet compression and coating
- Blending and granulation (often multiple unit operations)
- Secondary packaging and labeling
What to treat as “the supplier” in procurement and risk: Use the FDA-registered drug product manufacturer(s) as the authoritative finished-dose supplier set for capacity planning, API availability risk, and regulatory change management.
Multi-site supply and continuity planning
When multiple manufacturing sites exist, diligence should track:
- Which site has the commercial supply contract for each strength/packaging configuration
- Whether the same site controls both blending and final release
- Whether packaging is done at the same site or at a separate packaging facility
Who packages and labels Synjardy XR in the US market?
Secondary packaging and labeling are often done by a separate facility from the tablet manufacturing site.
Key due diligence targets:
- FDA-registered packaging operations for the product (where listed)
- Whether unit-of-use packs (bottles/blisters) use standardized components from a limited vendor list
- Labeling authority and print vendor contracts
What are the FDA-linked sources to identify Synjardy XR suppliers?
Primary supplier trace channels used in business due diligence:
- FDA product listing and registration records (drug product and drug substance)
- FDA Establishment Registration and Listing (which points to facility registration)
- Generic and CMC filings that reference comparability and manufacturing controls (when available in litigation or discovery contexts)
- Labeling and package insert manufacturing information (often less complete than FDA registration)
For finished-dose supplier identification: rely on FDA listing records for the specific National Drug Code (NDC) configurations marketed as Synjardy XR.
Synjardy XR supply chain risk points: what can disrupt suppliers?
In combination products, disruptions often come from:
- API constrained supply for empagliflozin
- XR formulation excipient shortages (release-control systems can be vendor- and grade-specific)
- Packaging bottlenecks (bottle caps, labels, cartons)
- Batch release delays tied to quality events or analytical method changes
Procurement implication: dual-sourcing at the API and finished-dose manufacturing levels is the main mitigation levers for supply continuity.
Key Takeaways
- “Synjardy XR suppliers” should be defined as either API suppliers, finished-dose manufacturers, or packaging/secondary manufacturers because each is governed by different regulatory records.
- Finished-dose supplier identification for procurement and regulatory diligence is anchored in FDA registration and listing data by NDC configuration.
- Empagliflozin is the more constraint-prone API for SGLT2 inhibitors, while XR metformin supply is more sensitive to release-control formulation and excipient sourcing.
- The most actionable supplier set for operational risk is the FDA-registered drug product manufacturing sites plus the packaging/labeling facilities tied to commercial NDCs.
FAQs
- How do I find the FDA-registered manufacturer for Synjardy XR by NDC?
- Do empagliflozin API suppliers differ from finished-dose CMOs for Synjardy XR?
- What parts of the Synjardy XR supply chain are most vulnerable to shortages: APIs, excipients, or packaging?
- How does Synjardy XR manufacturing site redundancy reduce drug shortage risk?
- What information in Synjardy XR labeling versus FDA listings is best for supplier verification?
References
- U.S. Food and Drug Administration. Drug Registration and Listing. FDA.
- U.S. Food and Drug Administration. National Drug Code (NDC) Directory and Product Data. FDA.
