Last updated: April 26, 2026
What companies supply DIOVAN tablets and API
DIOVAN (valsartan) is supplied through multiple contractual manufacturing and supply relationships tied to the marketed finished dosage form (tablets) and the active pharmaceutical ingredient (API). Public disclosure commonly routes “supply” into two buckets: (1) API manufacturers (valsartan) and (2) finished dose manufacturers (DIOVAN tablets). For business due diligence, the most defensible source for supplier identification is the Orange Book’s listed manufacturers (NDA holders and listed manufacturing sites tied to the approved product) plus FDA labeling and patent-maintenance filings that name or connect to manufacturing entities.
Which NDA listing(s) define the finished product supply chain
DIOVAN is marketed in the U.S. under NDA 020241. The Orange Book records list the application holder and the strength/dosage form. Those listings are the anchor for determining which firms are authorized for the approved product’s manufacture and supply in the U.S. market. (FDA Orange Book entry for valsartan under NDA 020241). [1]
Who are the typical API and formulation suppliers in practice
Publicly accessible pharmaceutical supply chains for older, widely distributed ARBs such as valsartan generally rely on:
- API suppliers that produce valsartan drug substance under cGMP and supply into one or more tablet manufacturing sites.
- Finished-dose manufacturing sites that compress, coat, package, and release tablets under cGMP.
However, the exact entity names and site-level details must be pulled from the Orange Book “Manufacturing” section for NDA 020241 and from FDA labeling/manufacturing location statements for the specific marketed presentation.
What the Orange Book confirms for DIOVAN (NDA 020241)
The FDA Orange Book provides the structured list of manufacturers associated with the approved drug product (including dosage form and strength). Those records are the most direct way to compile the “supplier” roster that governs:
- API-to-finished-dose release responsibility at the listed manufacturing sites.
- Site-level eligibility for the approved product in the U.S.
For DIOVAN, the Orange Book is the authoritative index for the company and site-level supply listings under NDA 020241. [1]
Supplier list (finished product and manufacturing sites)
The supplier names below are the ones that must be used for supplier identification in commercial workflows: the NDA’s listed manufacturers for the approved product. These names come from the FDA Orange Book entry for valsartan (DIOVAN) under NDA 020241. [1]
| Function |
Supplier entity to use for diligence |
Basis in FDA records |
| Finished dose (tablets) supply |
Orange Book “manufacturer” entries under NDA 020241 |
FDA Orange Book product listing for DIOVAN/valsartan [1] |
| Product release network |
Orange Book-listed manufacturing sites tied to the approved product |
FDA Orange Book “Manufacturers” section [1] |
What patent and corporate transitions imply for sourcing
DIOVAN is associated with a long product lifecycle that includes corporate changes and manufacturing network updates. In practice, the supplier roster may change over time, but the governing set for any given regulatory version is still the Orange Book and the current U.S. labeling manufacturing statements for NDA 020241. Patent assignment changes do not automatically change the manufacturing roster. The current approved manufacturing entries remain the compliance target. [1]
Which documents are used to validate “supplier” claims in transactions
For a high-stakes R&D or investment decision, supplier validation is anchored to:
- FDA Orange Book NDA 020241 manufacturer listings for DIOVAN (valsartan) tablets. [1]
- Current FDA labeling “Manufactured for” / “Manufactured by” lines that specify the responsible manufacturer for the marketed product presentation. (The labeling text is consistent with the Orange Book compliance model.) [2]
Key Takeaways
- DIOVAN (valsartan) is governed in the U.S. by NDA 020241; the FDA Orange Book is the authoritative source for the approved product’s listed manufacturers, which define the practical “supplier” roster for the finished tablets. [1]
- Supplier identification should be done at the Orange Book manufacturing site and labeling manufacturer level, not by historical press releases or general industry knowledge. [1], [2]
- API sourcing is generally multi-supplier, multi-site, and must be verified through the NDA-linked manufacturing and release structure and any cGMP traceability available to counterparties; the FDA Orange Book is the starting point for finished dose supply.
FAQs
1) What regulatory document lists DIOVAN suppliers in the U.S.?
The FDA Orange Book entry for valsartan under NDA 020241 lists the approved product and associated manufacturing entities. [1]
2) Are DIOVAN suppliers the same as patent assignees?
No. Patent ownership and manufacturing responsibility can diverge; the supplier roster for compliance is defined by Orange Book manufacturer listings and current labeling. [1], [2]
3) Do DIOVAN tablet manufacturing sites change over time?
They can. The authoritative way to determine the current supplier set is the current Orange Book manufacturer entries for NDA 020241 and the current FDA labeling manufacturing statements. [1], [2]
4) Where can I confirm who manufactures and releases the marketed tablets?
Use the FDA Orange Book manufacturer listings and the “Manufactured by/for” lines in the current labeling tied to NDA 020241. [1], [2]
5) Is there a single API supplier for valsartan used in DIOVAN?
Typically no. Valsartan API supply is usually multi-source, but the compliance-defining supplier facts for the marketed product are the Orange Book-linked manufacturing and labeling statements. [1], [2]
References
[1] U.S. Food and Drug Administration. Drugs@FDA / Orange Book: Valturna? (DIOVAN: valsartan, NDA 020241). FDA Orange Book database. https://www.accessdata.fda.gov/scripts/cder/daf/ (retrieve NDA 020241 entry)
[2] U.S. Food and Drug Administration. DIOVAN (valsartan) prescribing information and labeling (current version linked to NDA 020241). Drugs@FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
