Last Updated: June 9, 2026

Suppliers and packagers for exforge


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exforge

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990 NDA Novartis Pharmaceuticals Corporation 0078-0488-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0488-15) 2007-06-20
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990 NDA Novartis Pharmaceuticals Corporation 0078-0489-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0489-15) 2007-06-20
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990 NDA Novartis Pharmaceuticals Corporation 0078-0490-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0490-15) 2007-06-20
Novartis EXFORGE amlodipine besylate; valsartan TABLET;ORAL 021990 NDA Novartis Pharmaceuticals Corporation 0078-0491-15 30 TABLET, FILM COATED in 1 BOTTLE (0078-0491-15) 2007-06-20
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for exforge

Last updated: April 24, 2026

Who Supplies Exforge (Amlodipine + Valsartan) to the Market?

Exforge is a fixed-dose combination (FDC) of amlodipine (as besylate) and valsartan. However, no source-proven supplier list for Exforge products (by manufacturer, API supplier, or finished-dose supplier) is available in the information provided. Without verifiable, product-specific supply-chain data, any supplier identification would be speculative and non-actionable.

What supplier data is typically required to name Exforge suppliers?

A complete, defensible answer requires at least one of the following, tied to Exforge (not just the molecules):

  • FDA Orange Book entry for Exforge (applicant/labeler and listed manufacturers)
  • ANDA/NDA submission history that links to finished-dose manufacturer and API/manufacturing sites
  • Global regulatory product dossiers (e.g., EU SmPC/PL, UK, Health Canada) that list manufacturer and packager
  • Commercial supply-chain disclosures (rare) that name API and FDF suppliers by site

Why supplier identification cannot be completed from the request alone

“Suppliers for Exforge” can mean different layers:

  • Labeler of the finished product (the party marketing the branded product)
  • Finished-dose manufacturer (site that makes tablets)
  • API supplier(s) for amlodipine and valsartan (chemical suppliers)
  • Contract manufacturer for formulation/packaging

Each layer requires product- and site-specific documentation. None is included in the prompt.

Key Takeaways

  • “Exforge suppliers” can refer to labeler, finished-dose manufacturer, API suppliers, or contract manufacturing sites.
  • A verifiable supplier list requires regulator-linked source data (e.g., FDA Orange Book/Drug Approvals database tied to Exforge).
  • The provided input does not contain those regulator-linked or dossier-linked facts, so a complete and accurate supplier list cannot be produced.

FAQs

1) Is Exforge supplied by a single manufacturer?
No. Branded FDCs often have a labeler plus multiple manufacturing and packaging sites across launches and inventory cycles.

2) Does “supplier” mean API supplier or tablet manufacturer?
It can mean either. API supplier and finished-dose manufacturer are different parties and must be distinguished.

3) Where are Exforge suppliers usually confirmed?
Regulatory listings such as the FDA Orange Book (labeler/manufacturing details for listed products) and corresponding approval documentation.

4) Can I infer Exforge suppliers from amlodipine and valsartan suppliers?
No. Molecule suppliers do not automatically map to the specific finished-dose Exforge product.

5) What is the fastest way to compile a credible Exforge supplier map?
Use regulator-linked product entries for Exforge to extract labeler, manufacturer sites, and any listed API manufacturing details.


References

[1] FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (Exforge). U.S. Food and Drug Administration.

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