Last updated: May 25, 2026
JENTADUETO XR is a fixed-dose combination of linagliptin and extended-release metformin. The key suppliers for the product are the product owner/license-holder (for brand strategy and labeling), the registered finished-dosage drug manufacturer(s) listed on the FDA label and in the Orange Book, and the contract manufacturers that produce the dosage form and perform packaging and release.
Important: A complete, accurate supplier map requires the exact FDA label/manufacturing- and Orange Book-linked applicant/manufacturer identifiers for JENTADUETO XR. If those identifiers are not present in the source text available here, no correct supplier list can be produced without introducing errors.
Who supplies JENTADUETO XR (linagliptin/metformin ER) to the market?
Answer: The supply chain for JENTADUETO XR typically includes: (1) the marketing authorization holder/brand owner, (2) one or more NDA/ANDA applicants and distributors listed for the product, and (3) registered manufacturers for drug product and packaging on the FDA label.
Which entities are usually shown on the JENTADUETO XR label as manufacturers?
Answer: Look for the FDA label sections titled “Manufactured for” and the company name(s) tied to the finished dosage form. Those label lines identify the responsible supplier(s) that handle production and release under FDA registration.
Where do Orange Book listings point for supplier responsibility?
Answer: The Orange Book record lists the applicant/manufacturer for the listed NDA and the NDA-associated strengths and dosage forms. That applicant name is the licensing and regulatory point of contact that downstream manufacturers and packagers usually serve.
What manufacturers produce JENTADUETO XR extended-release tablets?
Answer: JENTADUETO XR is made as a solid oral extended-release tablet. The tablet is produced by registered finished-dosage manufacturers. Exact site names and company legal entities must match the FDA label “manufactured for” lines and the Orange Book listing for JENTADUETO XR.
Are there multiple manufacturing sites for the same JENTADUETO XR strength?
Answer: Commonly yes. Multi-site supply occurs when different GMP sites produce strengths or handle packaging and release separately. The label and Orange Book must be checked to separate “drug substance” versus “drug product” and to identify each site.
Who supplies linagliptin and who supplies metformin ER used in JENTADUETO XR?
Answer: The product-level supplier list for JENTADUETO XR does not automatically reveal linagliptin API and metformin ER supply because API sourcing is often under separate commercial arrangements. Supplier identification requires API-level disclosures on FDA submissions, DMFs, or other regulatory documents, not just the brand label.
What can be concluded from product-level labeling alone?
Answer: Labeling reliably identifies finished dosage manufacturing and packaging/release entities for JENTADUETO XR. It often does not name API suppliers.
How to map API suppliers to final product suppliers?
Answer: In practice, API suppliers for linagliptin and metformin ER are linked through DMF references and manufacturing authorizations. That mapping requires DMF/site-level evidence, not available in the provided context.
Which contract manufacturers typically handle packaging and release of JENTADUETO XR?
Answer: Packaging and release are handled by registered sites whose names appear on the label. If those site lines are not available in the provided material, no reliable contract manufacturer list can be produced.
What supply risks matter for JENTADUETO XR shortages?
Answer: The supply-chain risk drivers are tied to (1) single-site production versus multi-site production, (2) the availability of the extended-release tablet manufacturing equipment and validated process windows, (3) API availability for linagliptin and metformin ER intermediates, and (4) packaging capacity and batch release logistics. Site-specific evidence is required to quantify risk.
What generic or authorized supply entrants could affect JENTADUETO XR availability?
Answer: Authorized generics and market entrants do not change the supplier list for JENTADUETO XR itself, but they can change overall market availability and contracting leverage. To identify them requires Orange Book and market-entry status for relevant ANDAs, which is not present in the provided context.
Key Takeaways
- JENTADUETO XR supply is anchored in FDA-identified finished-dosage manufacturer(s) and packaging/release suppliers shown on the product label and in Orange Book applicant/manufacturer fields.
- API supplier identification for linagliptin and metformin ER is not reliably inferable from brand-level labeling alone.
- A correct supplier list requires the exact FDA label “manufactured for” entity names and the Orange Book applicant/manufacturer entries for JENTADUETO XR; those source lines are not present in the information available here.
FAQs
- How do I identify the finished-dosage manufacturers for JENTADUETO XR? Use the FDA label “manufactured for” lines and match the NDA record in the Orange Book.
- Does JENTADUETO XR list API suppliers on the label? Typically no; the label most often names drug product manufacturers and packaging/release sites.
- Can multiple companies manufacture different strengths of JENTADUETO XR? Yes, strength-specific manufacturing or packaging site variation is common, and label/Oorange Book entries must confirm.
- Where can contract manufacturers for JENTADUETO XR be confirmed? In label manufacturer/packager lines and the registered site fields in FDA regulatory listings.
- What is the fastest way to build a supplier map for litigation or sourcing? Cross-reference label manufacturer names, NDA/Orange Book applicant identifiers, and GMP site registrations tied to the product dosage form.
References
No sources were provided in the prompt to cite.
