Last Updated: May 10, 2026

Suppliers and packagers for AVALIDE


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AVALIDE

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 AVALIDE hydrochlorothiazide; irbesartan TABLET;ORAL 020758 NDA Sanofi-Aventis U.S. LLC 0024-5855-30 30 TABLET, FILM COATED in 1 BOTTLE (0024-5855-30) 2013-01-01
Sanofi Aventis Us AVALIDE hydrochlorothiazide; irbesartan TABLET;ORAL 020758 NDA Sanofi-Aventis U.S. LLC 0024-5856-30 30 TABLET, FILM COATED in 1 BOTTLE (0024-5856-30) 2013-01-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Avalide (Irbesartan + Hydrochlorothiazide): Supplier Map for the Product and Key Inputs

Last updated: April 25, 2026

Who supplies Avalide to markets?

Avalide is marketed as a fixed-dose combination of irbesartan and hydrochlorothiazide. In practice, the “supplier” chain splits into two layers: (1) the legal marketing authorization holder (MAH) / brand owner in each country and (2) contract manufacturing and packaging networks that can vary by geography.

The information required to name specific, country-specific suppliers (MAH, contract manufacturers, and drug substance suppliers) is not present in the input provided. Without that, it is not possible to produce a complete and accurate supplier list.

Who supplies irbesartan (drug substance)?

Avalide’s active ingredient irbesartan is sourced from branded and generic irbesartan API manufacturers. A supplier-grade answer requires:

  • the API manufacturer(s) tied to the relevant product dossier(s), and
  • the particular grade/specification used (salt form, impurity profile, and particle spec).

Those dossier-level facts are not included in the request.

Who supplies hydrochlorothiazide (drug substance)?

Hydrochlorothiazide is widely supplied globally, but supplier identification still requires dossier or packaging-level traceability for the specific Avalide product line (by country, strength, and manufacturer). No such product-line detail is included in the request.

Who supplies finished-dose manufacturing and packaging?

Finished-dose supplier identity depends on the exact:

  • country market,
  • strength (Avalide typically includes multiple strengths),
  • marketing authorization, and
  • manufacturing site (often changes across launch cycles and line upgrades).

No geography, strength, or MAH/manufacturing site data is included, so a definitive supplier list cannot be produced from the provided information.


Key Takeaways

  • “Suppliers for Avalide” must be defined as MAH/brand owner, finished-dose manufacturer, and API suppliers.
  • The input contains no country, no strength, no MAH, and no dossier/manufacturing-site identifiers, so a complete and accurate supplier mapping cannot be generated.
  • A correct supplier answer requires dossier-linked traceability for irbesartan API, hydrochlorothiazide API, and the finished-dose manufacturing and packaging sites.

FAQs

  1. What does Avalide consist of?
    Avalide is a fixed-dose combination of irbesartan and hydrochlorothiazide.

  2. Is there one global supplier for Avalide?
    No. Avalide supply typically varies by country market and manufacturing authorization.

  3. Do irbesartan and hydrochlorothiazide come from the same suppliers?
    Not necessarily. API supply chains for each component can be independent.

  4. Does the finished-dose supplier stay the same over time?
    It can change due to contract manufacturing shifts, line upgrades, and regulatory manufacturing transfers.

  5. How are supplier identities verified for high-stakes decisions?
    Through regulatory dossier traceability (MAH and manufacturing sites) and API supplier linkage to the specific product registration.


References

[1] FDA Orange Book. (n.d.). Drug Products Listed in the Orange Book. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/ob/
[2] EMA. (n.d.). European Medicines Agency: Medicines. European Medicines Agency. https://www.ema.europa.eu/en/medicines
[3] DailyMed. (n.d.). Labeling for Avalide (irbesartan and hydrochlorothiazide). U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/

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