Last updated: April 25, 2026
Jentadueto is a fixed-dose combination of linagliptin + metformin (brand name). At the product level, supplier relationships are typically structured through (1) NDA/BLA holder supply chains, (2) drug substance (API) manufacturing sites, (3) finished-dose (FDF) manufacturing sites, and (4) packaging and labeling supply. Those supplier roles are reflected in FDA listings and inspections tied to the product.
Who are the “suppliers” for Jentadueto in practice?
In pharma procurement terms, “suppliers” usually map to four categories:
- Marketing authorization holder / brand owner (controls market supply via contracts)
- API manufacturers (linagliptin API; metformin API)
- Finished-dose manufacturers (tablets for the FDF)
- Packaging and distribution infrastructure (bottling/blister, labeling, secondary packaging)
For Jentadueto specifically, the operative supplier set must be confirmed through FDA product and establishment listings that enumerate the responsible manufacturers and sites.
Which documented manufacturing sites support Jentadueto supply?
Supplier-side manufacturing sites are identified in FDA data sources such as:
- FDA Orange Book (drug product and application identifiers; may link to manufacturing details by product)
- FDA NDC directory (product listing)
- FDA Establishment Registration and Listing (registered manufacturing establishments, where applicable)
This approach is the only defensible way to name “suppliers” at site level for a prescription fixed-dose combo drug.
What is the regulatory basis that lists Jentadueto manufacturing?
For a listed prescription drug, FDA maintains:
- Product listing via the NDC directory
- Establishment registration for facilities involved in manufacturing
These sources allow mapping from:
- product (Jentadueto strength/form) → NDC → listed establishments and manufacturing roles.
Key product identity needed to locate suppliers in FDA systems
Jentadueto is not one generic product; supplier listings must be tied to the specific marketed strength and dosage form because NDCs can differ by strength and packaging.
| Product element |
Jentadueto composition |
Supplier relevance |
| Drug type |
Fixed-dose combination |
Supplier mapping must cover both APIs and the finished tablet |
| Actives |
Linagliptin + Metformin |
Requires API + FDF supply chain coverage |
| Strengths / forms |
Strength-dependent NDCs |
Manufacturing sites can vary by strength |
Why suppliers differ by strength (and why that matters to procurement)
For combination tablets, the supplier set can change by:
- formulation changes across strengths (binder/filler composition, coating)
- packaging configuration (bottle vs blister)
- manufacturing campaign scheduling (site assignment by batch)
Procurement and contracting should therefore be strength-specific using the exact NDC.
What you should request from a vendor claiming to supply Jentadueto
A credible supplier response should provide, for each relevant strength:
- NDC number(s) covered
- manufacturing site(s) (establishment registration identifiers or site names)
- whether the vendor supplies FDF only or also offers API components
- GMP release source (site that performs batch release)
Key Takeaways
- “Suppliers for Jentadueto” must be defined by regulatory supplier roles: marketing authorization holder, API manufacturers (linagliptin and metformin), finished-dose manufacturers, and packaging/labeling.
- Supplier sites and names should be mapped through FDA NDC and establishment listings using the specific Jentadueto strength NDCs, because supplier assignments can differ by strength and packaging configuration.
- Vendor claims should be validated against NDC coverage and listed manufacturing establishments.
FAQs
-
Are API manufacturers the same as finished-dose manufacturers for Jentadueto?
Not necessarily. API and FDF manufacturing are often performed by different sites with separate GMP controls.
-
Does “supplier” mean the brand owner or the manufacturing sites?
In pharma, “supplier” can mean either, but the only actionable procurement definition is tied to manufacturing and release sites for the exact product NDC.
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Do supplier sites vary by Jentadueto strength?
Yes. Strength-specific NDCs can correspond to different manufacturing or packaging assignments.
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How should a procurement team verify Jentadueto suppliers?
By mapping Jentadueto strength/form to NDC, then using FDA listings to identify the registered manufacturing establishments tied to those products.
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Can a distributor supply Jentadueto without being a manufacturer?
Yes. Distributors commonly supply finished product sourced from the market supply chain; they do not control the manufacturing sites unless they are also the FDF manufacturer.
References
[1] U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
[2] U.S. Food and Drug Administration. National Drug Code (NDC) Directory.
[3] U.S. Food and Drug Administration. Drug Establishments Current Registration Site Information.
