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Spironolactone tablets bulk supplier for pharma manufacturers

Spironolactone Tablets 25 mg, 50 mg, 100 mg Suppliers & Bulk Manufacturers

Available Forms: Tablet

Available Strengths: 25 mg, 50 mg, 100 mg

Reference Brands: Aldactone(US & EU)

Category: Heart Disorder

Spironolactone is a potassium-sparing diuretic that blocks aldosterone receptors, reducing sodium and water retention while conserving potassium. It effectively treats heart failure, hypertension, and hormonal conditions like acne. Benefits include lowering blood pressure, reducing edema, improving cardiac function, and supporting hormone balance, enhancing overall cardiovascular and hormonal health.

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📘 Sourcing Guide

Product Description:

Spironolactone tablets, marketed as Aldactone, are approved in the US by the FDA and in the EU via EMA for conditions like edema, hypertension, and hyperaldosteronism. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed trial and quality data, while the EMA ensures compliance with safety and manufacturing standards across Europe. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional regulations supports timely approval, safe use, and broader global availability of spironolactone tablets, helping manage cardiovascular and hormonal health effectively worldwide

Spironolactone Tablets — third party manufacturing & bulk supply

Spironolactone Tablets 25 mg, 50 mg, 100 mg is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Spironolactone Tablets listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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Frequently Asked Questions

Spironolactone Tablets are used to treat conditions like hypertension, edema associated with heart failure, liver cirrhosis, or nephrotic syndrome. They are also used in managing hyperaldosteronism and sometimes in hormonal therapy for acne, hirsutism, or polycystic ovary syndrome (PCOS) due to their anti-androgen effects.

The tablets are made from spironolactone, a potassium-sparing diuretic that works by antagonizing aldosterone receptors in the kidneys, reducing sodium and water retention while conserving potassium, which helps manage fluid overload and blood pressure.

Common trade names include Aldactone, Spirolon, Verospiron, and Carospir, along with various generic formulations worldwide.

Aldactone is marketed by Pfizer, Verospiron by Bayer in Europe, and Spirolon and Carospir by multiple generic manufacturers in India and LATAM.

The generic name is spironolactone.

Brand names include Aldactone, Spirolon, Verospiron, Carospir, and various regional generic brands.

It is manufactured in GMP-certified pharmaceutical facilities across the USA, Europe, India, and Latin America.

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