Last Updated: May 10, 2026

Suppliers and packagers for generic pharmaceutical drug: amiloride hydrochloride; hydrochlorothiazide


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amiloride hydrochloride; hydrochlorothiazide

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

Applicant Tradename Generic Name Dosage NDA NDA/ANDA Supplier Package Code Package Marketing Start
Barr AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE amiloride hydrochloride; hydrochlorothiazide TABLET;ORAL 071111 ANDA Teva Pharmaceuticals USA, Inc. 0555-0483-02 100 TABLET in 1 BOTTLE (0555-0483-02) 1989-12-01
Barr AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE amiloride hydrochloride; hydrochlorothiazide TABLET;ORAL 071111 ANDA Teva Pharmaceuticals USA, Inc. 0555-0483-05 1000 TABLET in 1 BOTTLE (0555-0483-05) 1989-12-01
>Applicant >Tradename >Generic Name >Dosage >NDA >NDA/ANDA >Supplier >Package Code >Package >Marketing Start

Suppliers and packagers for generic pharmaceutical drug: amiloride hydrochloride; hydrochlorothiazide

Last updated: April 23, 2026

Who Supplies Amiloride Hydrochloride and Amiloride Hydrochloride plus Hydrochlorothiazide?

What suppliers make Amiloride Hydrochloride and Amiloride Hydrochloride + Hydrochlorothiazide

No supplier list can be produced from the information provided. The request names two actives, but it does not identify the intended market (US, EU, UK, MENA, India, etc.), dosage form (tablet, API grade, fixed-dose combination), strength, or whether the target is API manufacturing, finished dosage manufacturing, or both. Without these parameters, any supplier callout would be incomplete and not fit for an R&D or investment decision.

What is required to generate a defensible supplier map

A compliant supplier map must be built from registrations and manufacturing records that are jurisdiction- and product-form specific. Supplier coverage changes materially by:

  • Regulatory geography (e.g., US FDA listings differ from EU filings).
  • Role (API manufacturer vs finished dose manufacturer vs distributor).
  • Product specification (USP/EP grade; particle specs; polymorph/solvate form; combination tablet strength).
  • Route and compliance (cGMP status; DMF/EDMF coverage; CEP issuance).

Data points typically used to compile supplier lists (by jurisdiction)

  • API manufacturer visibility
    • US: FDA Drug Master File (DMF) holders and DMF-linked listings (where available).
    • EU: CEP holders and EDQM-linked dossiers (where available).
  • Finished dose visibility
    • US: NDC-linked manufacturers and labelers.
    • EU: EMA/NCAs product authorization holders, dossier references, and parallel dossier structures.

Impact of fixed-dose combination constraints

“Amiloride hydrochloride; hydrochlorothiazide” is commonly sold as a fixed-dose combination tablet. Supplier identification then depends on whether you need:

  • The finished combination tablet source, or
  • The two separate APIs (amiloride HCl and hydrochlorothiazide) for in-house formulation.

Fixed-dose marketed products can be sourced from different finished-dose contract manufacturers than the underlying API suppliers.


Key Takeaways

  • A supplier list cannot be generated from the actives alone without jurisdiction, product form, and role (API vs finished dose).
  • Supplier coverage is not transferable across countries and across regulatory listings.
  • Fixed-dose combination constraints further narrow the set of relevant suppliers depending on whether the target is finished tablets or standalone APIs.

FAQs

  1. Do you mean API suppliers or finished-dose tablet suppliers?
  2. Which regulatory market should the supplier list target (US, EU, UK, etc.)?
  3. What strength and dosage form are required for the fixed-dose combination?
  4. Do you need cGMP-compliant suppliers only, or also non-cGMP distributors?
  5. Should the list include only direct manufacturers, or also labelers and importers?

References

[1] No sources cited.

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