Spironolactone Tablets 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.
Spironolactone tablets is available in Tablet
and strengths such as 25 mg, 50 mg, 100 mg.
Sourced from GMP-certified and ISO-compliant manufacturers, this API meets
global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical
formulation and commercial manufacturing, Spironolactone tablets is supplied in
bulk quantities with complete regulatory support including DMF, COA, and MSDS.
|
Technical Specifications & Supply Details
|
| Lead Time |
7 to 60 days (depending on batch size & schedule) |
| MOQ |
As per manufacturer’s batch size |
| COA |
Available with every batch |
| Regulatory Dossier / DMF |
Available upon request |
| Export Documentation |
FSC, COA, Manufacturing License, Product Permission |
| Standards |
IP, BP, USP |
| Certifications |
WHO-GMP, EU-GMP, USFDA (as applicable) |
Spironolactone tablets can be exported to over 30 countries across Asia, Africa, Europe,
and Latin America. Flexible packaging, competitive pricing, and a verified supplier
network make Pharmatradz a trusted sourcing partner for pharmaceutical companies
and contract manufacturers worldwide.
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
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