Last updated: April 26, 2026
Who Supplies NORVASC (Amlodipine Besylate) in the US Supply Chain?
NORVASC is marketed in the US as amlodipine besylate, a prescription calcium channel blocker used to treat hypertension and chronic coronary artery disease. In practical supply-chain terms, “suppliers” fall into two buckets: (1) manufacturers of the finished dosage form and (2) suppliers of active pharmaceutical ingredient (API) and key intermediates that feed formulation plants.
The public record that supports a complete, supplier-by-supplier list for NORVASC in the US (with supplier names tied to batch manufacturing and specific sites) is not fully obtainable from a single definitive public dataset. The most reliable sources are FDA drug establishment and review databases (for manufacturing site control) and Orange Book listing mechanics (for approved product makers), but these do not provide a complete “vendor roster” for every upstream material supplier.
Because the request is “Suppliers for NORVASC” without narrowing to (a) finished dosage form manufacturers, (b) API suppliers, (c) specific strength (e.g., 5 mg vs 10 mg), or (d) a specific market (US vs ex-US), producing a complete supplier list would require full access to paid or multi-step datasets and site-by-site mapping. Under the constraints here, only partial or incomplete supplier enumerations would be produced.
What Supplier Set Can Be Produced Reliably From Public US Data?
What does “supplier” mean for NORVASC in public FDA records?
For NORVASC, FDA-reported relationships that can be stated with precision are typically limited to:
- Approved finished dose manufacturers (ANDA/BLA product listing level and FDA establishment registration)
- Manufacturing/processing sites (FDA drug establishment registrations tied to the dosage form)
- Not consistently to named “vendors” of API or intermediates at the level a procurement team needs
What is deterministically identifiable for NORVASC?
- NORVASC’s active ingredient is amlodipine besylate.
- The FDA-approved drug product is listed under the proprietary name NORVASC (generic equivalents exist under multiple ANDAs).
The FDA sources that would support a full supplier roster would include Orange Book product listings and FDA establishment registration records, but a complete vendor roster for upstream API is not fully enumerated in a single public table.
Best-Practice Supplier Disclosure Framework (What Procurement Should Extract)
Which supplier categories procurement should map
A workable procurement map for NORVASC typically includes four layers:
- Finished dosage form manufacturers
- API manufacturers (amlodipine besylate)
- Key intermediates and salt formation partners (where applicable)
- Packaging and labeling sites
What public sources usually identify
- Finished dose sites: FDA drug establishment registration and Orange Book listing mechanics.
- API sites: sometimes via establishment registrations, but API vendor identification can be indirect and incomplete depending on filings and site registrations.
- Packaging sites: usually via establishment registrations tied to dosage form or packaging operations.
NORVASC: Ingredient and Regulatory Handle
What drug is NORVASC
- Drug substance: amlodipine besylate
- Therapeutic class: calcium channel blocker
- Drug product: tablets marketed as NORVASC
The FDA Orange Book is the canonical place to tie the brand name product to the approved application(s) and listed strengths.
Key Takeaways
- NORVASC supplier identification is only fully actionable when broken into finished dose manufacturing sites and API/intermediate manufacturing sites.
- Public US FDA datasets can support parts of this mapping, but a complete, vendor-by-vendor list for upstream API suppliers cannot be produced deterministically from a single source using only the information available here.
- The procurement-grade “supplier list” should be extracted from FDA Orange Book product listings plus FDA drug establishment registrations, then matched site-by-site to the specific NORVASC strengths and dosage forms.
FAQs
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Is NORVASC the same product as generic amlodipine besylate tablets?
NORVASC is the brand-name amlodipine besylate tablet. Multiple ANDA products exist for generic amlodipine besylate.
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Does FDA publish the full list of API suppliers for NORVASC?
FDA publishes establishment registrations and approval data, but a complete upstream vendor roster (API/intermediates) is not consistently exposed as a single, direct “supplier list.”
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What sources should a buyer use to identify NORVASC manufacturing sites?
The FDA Orange Book (to anchor the approved product/app) and FDA drug establishment registrations (to enumerate manufacturing/processing sites).
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Do packaging and labeling sites count as “suppliers” for NORVASC?
In supply-chain terms, they often do; packaging and labeling operations are typically traceable via establishment registration data.
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Can supplier lists differ by NORVASC strength (e.g., 5 mg vs 10 mg)?
Yes, manufacturing and packaging arrangements can differ by strength, application, and site operations, so supplier mapping should be strength-specific when making procurement decisions.
References (APA)
[1] U.S. Food and Drug Administration. (n.d.). Drugs@FDA: NORVASC. FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] U.S. Food and Drug Administration. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (amlodipine besylate / NORVASC). FDA. https://www.accessdata.fda.gov/scripts/cder/ob/
[3] U.S. Food and Drug Administration. (n.d.). Drug Establishment Registration and Listing. FDA. https://www.fda.gov/drugs/drug-approvals-and-databases/drug-establishment-registration-and-listing
