Suppliers and packagers for AVAPRO

AVAPRO

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757	NDA	Sanofi-Aventis U.S. LLC	0024-5851-30	30 TABLET, FILM COATED in 1 BOTTLE (0024-5851-30)	2013-01-01
Sanofi Aventis Us	AVAPRO	irbesartan	TABLET;ORAL	020757	NDA	Sanofi-Aventis U.S. LLC	0024-5852-30	30 TABLET, FILM COATED in 1 BOTTLE (0024-5852-30)	2013-01-01

Avapro (irbesartan) suppliers: who manufactures and supplies the drug in the US and globally

Last updated: May 30, 2026

Avapro is the brand of irbesartan, an angiotensin II receptor blocker (ARB). The practical “supplier” landscape is split between (1) manufacturers of the active pharmaceutical ingredient (API) irbesartan and (2) suppliers of finished-dose products sold as Avapro (tablets) in the US. Coverage depends on the specific market (US retail vs. hospitals vs. foreign), dosage strength, and the specific NDA holder and authorized labelers listed by FDA.

Who supplies Avapro (irbesartan) tablets in the US?

Featured snippet answer: Avapro is an FDA-labeled brand product. In the US supply chain, the identity of the immediate finished-goods manufacturer(s) is reflected in FDA labeling and the “Application Holder” and labeler/manufacturer data tied to the listed product. The FDA’s databases that map directly to product-level manufacturing are the Labeling and Orange Book entries for the Avapro NDA.

Which NDA and labeler structure governs Avapro supply?

• Active ingredient: irbesartan
• Brand product: Avapro
• Regulatory anchor: FDA Orange Book listing for the Avapro NDA (product-level listings show application holder and relevant patent/exclusivity status, and they link to the listed dosage forms sold under the brand name)

What does the Orange Book listing tell you about supply?

Orange Book entries do not enumerate “suppliers” the way an ingredient bill of materials would, but they provide the official product linkage that matters for procurement and contracting:

• Application holder / NDA sponsor: controls authorized manufacturing and distribution channels.
• Listed dosage form(s): confirms tablet strengths and product format.
• Patents and exclusivity: determines timeline pressure that drives manufacturing reallocation and contracting behavior across authorized generics and authorized production changes.

What companies manufacture irbesartan API used in Avapro supply chains?

Featured snippet answer: Irbesartan API is manufactured by multiple API suppliers globally; Avapro’s specific API supplier is not determinable from Orange Book alone and is typically visible through drug master file (DMF) references, supplier qualification disclosures, or direct labeler/manufacturing sites in FDA labeling for the finished product. API supplier lists also change with technology transfers and supply continuity planning.

Global irbesartan API supplier categories that show up in the market

In practice, irbesartan API is sourced from:

• Specialty ARB API manufacturers supplying multiple global labelers
• Generic API producers with DMF submissions to support NDA ANDA dossier needs
• Integrated manufacturers that make API and finished tablets for regional markets

Why API sourcing matters for Avapro procurement

• Supply continuity: ARB API has episodic capacity constraints and compliance-driven shifts.
• Change-control risk: any API supplier swap in controlled manufacturing can trigger comparability work, particularly for long-running branded supply.
• Regulatory traceability: procurement teams need the finished-dose manufacturer and the controlled chain-of-custody from GMP sites.

Which finished-dose manufacturers supply Avapro tablets (strength-by-strength)?

Featured snippet answer: Finished-dose manufacturers are identified in FDA labeling and the specific product manufacturing site information. For Avapro, “who manufactures” is captured through the product’s labeled manufacturing details tied to the approved labeling and distribution.

What dosage strengths define separate manufacturing runs?

Avapro is typically marketed in multiple tablet strengths (procurement usually tracks each strength separately for supply assurance). Each strength can have different manufacturing batches and sometimes different release sites.

How to map “supplier” for internal sourcing

A defensible sourcing map uses:

• FDA labeling manufacturing site(s) for the Avapro tablets
• Distribution/labeling records tied to the NDA
• Lot-level distribution data
• Supplier qualification on incoming COA and GMP compliance

What is Avapro’s Orange Book status and does it affect supplier landscape?

Featured snippet answer: Avapro’s Orange Book status affects competition and therefore supplier strategy, but it does not by itself list ingredient or contract-manufacturing suppliers.

Why exclusivity and patent cliffs change supplier behavior

When patent protection and exclusivity run down:

• branded supply contracts often expand to additional GMP sites
• bottleneck API sources can be diversified
• authorized production or alternative manufacturing lines become more likely

Patent listings drive generic entry timing, which drives supplier churn

Your procurement and litigation risk horizon is tied to:

• listed patents
• expiration dates
• exclusivity periods
• Paragraph IV filings (if any for irbesartan generics that compete with Avapro)

Are there authorized generics for irbesartan that compete with Avapro supply?

Featured snippet answer: Competition in the US branded ARB space is usually dominated by generic irbesartan tablets rather than an “authorized generic” concept for Avapro, unless a specific authorized generic arrangement is active for the branded NDA.

What generic entry does to the supplier map

When generics launch:

• existing branded supply capacity can be reallocated
• API suppliers shift mix toward high-volume generic demand
• finished-dose contract manufacturers add tablet formats and strengths

What Paragraph IV challenges or patent litigation affect Avapro’s supply and supplier diversification?

Featured snippet answer: Patent litigation affects generic launch timing; it indirectly affects supplier diversification by shaping market demand volatility for irbesartan tablets.

Litigation timeline effects on manufacturing contracting

• If litigation delays generic approval, branded and pre-launch generic contract manufacturing schedules change.
• If litigation accelerates settlement, suppliers reallocate toward ramped generic demand.

Supply impact is downstream of FDA decisions

The relevant operational trigger is FDA approval and commercialization timing, not the existence of patents alone.

How does Avapro compare to generic irbesartan suppliers and what does that mean for procurement?

Featured snippet answer: Avapro is a brand with controlled manufacturing authorization; generic irbesartan is produced by multiple companies with different cost structures and manufacturing networks.

Procurement comparison table: branded vs generic irbesartan

Item	Avapro (irbesartan brand)	Generic irbesartan tablets
Supplier set	fewer authorized finished-dose manufacturers tied to NDA labeling	many GMP sites and labelers
Contracting	brand continuity contracts and quality agreements	competitive bids and multi-source stocking
Demand stability	depends on patent/exclusivity and payer mix	sensitive to launch timing and market share
Quality system	NDA-specific release specs and documentation chain	ANDA/authorized generic/QMS aligned to FDA approved specs

What foreign market suppliers matter if Avapro is sourced internationally?

Featured snippet answer: If Avapro is sourced from outside the US, “supplier” depends on local marketing authorization holders and the GMP sites for the registered product in each country.

Geographic sourcing changes the answer

• EU/UK markets often show different manufacturers and packagers
• Middle East and LATAM sourcing frequently uses region-specific GMP sites
• Tender procurement can require local regulatory registration, altering the supplier list

What manufacturing/IP barriers exist for new suppliers entering Avapro’s supply chain?

Featured snippet answer: Barriers for new suppliers are not primarily “patent barriers” to manufacturing an ARB, since generics can manufacture irbesartan, but they are contract and regulatory barriers to selling the branded Avapro NDA product.

Practical barriers procurement teams face

• NDA labeling authorization for branded product manufacture and release
• GMP site qualification under NDA specifications
• Quality agreement requirements and long-term stability data expectations
• Packaging and traceability obligations tied to brand distribution

Key Takeaways

• Avapro is a branded irbesartan tablet product; “supplier” in practice means the NDA-controlled finished-dose manufacturing sites plus the underlying GMP-qualified API supply chain.
• Orange Book and FDA listing infrastructure determines the official product regulatory anchor, while API supplier identities typically require finished-dose labeling manufacturing site data and dossier-linked DMF references.
• Patent status and litigation do not list suppliers, but they do reshape demand and therefore drive finished-dose and API supplier diversification over time.
• Branded Avapro sourcing is contract- and NDA-authorized; generic irbesartan sourcing is multi-site and competitive.

FAQs

1) What active ingredient does Avapro use?
Avapro uses irbesartan, an angiotensin II receptor blocker (ARB).

2) Does the Orange Book list the API or API suppliers for Avapro?
No. The Orange Book lists patents and exclusivity tied to approved drug products; it does not enumerate API supplier identities.

3) How do generics of irbesartan affect Avapro supply contracts?
Generic launch changes volume expectations, which can drive branded manufacturers to reallocate capacity and diversify contract-manufacturing and release sites.

4) What are typical “supplier” constraints for branded Avapro versus generic irbesartan?
Branded Avapro is limited to NDA-authorized manufacturing and release pathways, while generic irbesartan can be supplied by multiple ANDA-qualified sites.

5) What matters most for procurement: manufacturer of tablets or manufacturer of API?
For compliance and lot release, the finished-dose manufacturer listed in labeling and GMP release documentation is primary; API supplier matters for continuity risk and supply chain assurance.

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US FDA. https://www.accessdata.fda.gov/scripts/cder/daf/
2. FDA. Drug Labeling (Approved Labeling and Package Inserts). US FDA. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm
3. FDA. Drug Master Files (DMF): Overview and regulatory framework. US FDA. https://www.fda.gov/drugs/dmfs/drug-master-files-dmf