GENERIC NAME OF THE MEDICINAL PRODUCT:
B) Spironolactone Tablets USP 50mg
C) Spironolactone Tablets USP 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each uncoated tablet contains:
Spironolactone USP…………………25mg
Excipients………………………………..q.s.
B) Spironolactone Tablets USP 50mg
Each uncoated tablet contains:
Spironolactone USP…………………50mg
Excipients…………………………………q.s.
C) Spironolactone Tablets USP 100mg
Each uncoated tablet contains:
Spironolactone USP…………………100mg
Excipients…………………………………q.s.
THERAPEUTIC INDICATIONS:
CAUTION & WARNING:
Read enclosed leaflet before use.
KEEP MEDICINE OUT OF REACH OF CHILDREN.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Dispense in tight container.
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
Spironolactone Tablets 25mg Technical Specification:
| Product Name: | Spironolactone Tablets USP |
| Brand Name: | Generic |
| Strength: | 25mg, 50mg, 100mg |
| Dosage Form: | Tablets (Uncoated) |
| Route of Administration: | Via Oral Route |
| Packing: | 10s, 30s, 100s, 500s |
| Pack Insert/Leaflet: | PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics) |
| Regulatory Documents: | COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier |
| Therapeutic use: | Antihypertensive, Antianginal, Diuretics |
| Indication: | Spironolactone is used in combination with other medicines to treat high blood pressure (hypertension) and heart failure. |
| Storage: | Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. |
GENERIC NAME OF THE MEDICINAL PRODUCT:
A) Spironolactone Tablets USP 25mg
B) Spironolactone Tablets USP 50mg
C) Spironolactone Tablets USP 100mg
QUALITATIVE AND QUANTITATIVE COMPOSITION:
A) Spironolactone Tablets USP 25mg
Each uncoated tablet contains:
Spironolactone USP…………………25mg
Excipients………………………………..q.s.
B) Spironolactone Tablets USP 50mg
Each uncoated tablet contains:
Spironolactone USP…………………50mg
Excipients…………………………………q.s.
C) Spironolactone Tablets USP 100mg
Each uncoated tablet contains:
Spironolactone USP…………………100mg
Excipients…………………………………q.s.
THERAPEUTIC INDICATIONS:
Spironolactone is used to treat high blood pressure and heart failure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. It is also used to treat swelling (edema) caused by certain conditions (such as heart failure, liver disease) by removing excess fluid and improving symptoms such as breathing problems.This medication is also used to treat conditions in which the body is making too much of a natural substance (aldosterone).Spironolactone is known as a “water pill” (potassium-sparing diuretic).
CAUTION & WARNING:
CAUTION: Read enclosed leaflet before use.
Keep medicine out of reach of children.
SWALLOW WHOLE DO NOT CHEW OR CRUSH
Warning: To be sold by retail on the prescription of a Registered Medical Practitioner only.
STORAGE & DOSAGE:
Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
Dispense in tight container.
Protect from light and moisture.
Dosage: As directed by the Physician
Attach dispensing label as per end country.
Introduction to Spironolactone Tablets 25mg
Spironolactone Tablets 25mg are a widely used potassium-sparing diuretic (water pill) that treats high blood pressure, heart failure, and edema caused by kidney, liver, or heart conditions. This medicine is also highly effective in managing hypokalemia (low potassium levels) and certain hormonal disorders, such as hyperaldosteronism.
Globally, Spironolactone Tablets 25mg are in high demand because of:
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Increasing prevalence of hypertension and cardiovascular disorders
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Rising awareness about fluid retention management
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Growing requirement for high-quality, WHO-GMP-certified medicines
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Expanding healthcare infrastructure in emerging and developed markets
Taj Pharma, a premier Spironolactone Tablets 25mg manufacturer in India, provides top-quality, certified tablets for hospitals, distributors, and international buyers.
In-Depth Details for Importers, Exporters, and Buyers
Regulatory Documentation Provided
Taj Pharma ensures full compliance with international pharmaceutical standards. Buyers and importers are provided with:
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WHO-GMP and EU-GMP certification
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Certificate of Pharmaceutical Product (COPP)
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CTD/eCTD dossiers for regulatory approvals
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Batch records, stability reports, and quality validation
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Free Sale Certificates for global markets
Custom Packaging & Labeling
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Private labeling and branding for distributors
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Multi-language packaging for international markets
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Packaging in blister packs, strip packs, and bottles
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Compliance with international safety and transport regulations
Shelf-Life, Storage, and Dosage Form
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Dosage Strength: 25mg
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Dosage Form: Tablet
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Shelf-Life: 24–36 months
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Storage: Store below 25°C, dry, and away from sunlight
Export Certifications
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WHO-GMP, EU-GMP certified
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ISO 9001:2015 compliance
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COPP and CTD dossier documentation
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Stability and quality assurance reports
Target Countries & Export Markets
Taj Pharma exports Spironolactone Tablets 25mg to over 50 countries, including:
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Asia: Nepal, Bangladesh, Sri Lanka, Vietnam
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Africa: Nigeria, Kenya, South Africa, Ghana
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Middle East: UAE, Saudi Arabia, Oman, Iraq
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Latin America: Peru, Colombia, Chile, Bolivia
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Europe & CIS: Russia, Kazakhstan, Uzbekistan, Kyrgyzstan
Why is the Most Trusted Manufacturer/Supplier/Exporter
Taj Pharma is recognized worldwide as a reliable Spironolactone Tablets 25mg manufacturer in India, known for quality, affordability, and global supply reliability.
State-of-the-Art Manufacturing
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Advanced facility located in Vapi, Gujarat
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WHO-GMP and EU-GMP-certified production
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Fully equipped R&D and quality control laboratories
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High-precision machinery ensures uniform, top-quality tablets
Affordable Pricing & Quality Assurance
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Competitive pricing for bulk and retail orders
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Multi-step quality control for purity and potency
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Cost-effective, high-quality Spironolactone Tablets 25mg for international buyers
Global Presence & Supply Chain Support
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Reliable exports to over 50 countries
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Timely delivery with secure logistics
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Assistance with regulatory approvals and market registration
Top 20 Countries Exporting
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Nepal
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Bangladesh
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Sri Lanka
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Vietnam
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Nigeria
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Kenya
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South Africa
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Ghana
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UAE
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Saudi Arabia
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Oman
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Iraq
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Peru
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Colombia
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Chile
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Bolivia
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Russia
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Kazakhstan
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Uzbekistan
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Kyrgyzstan
Technical Product Specification Table
| Parameter | Specification |
|---|---|
| Product Name | Spironolactone Tablets 25mg |
| Dosage Form | Tablet |
| Strength | 25mg |
| Active Ingredient | Spironolactone |
| Pharmacological Class | Diuretic (Potassium-sparing) |
| Indications | Hypertension, Heart Failure, Edema, Hypokalemia |
| Packaging Options | Blister / Strip Packs / Bottles |
| Storage Conditions | Store below 25°C, dry, away from sunlight |
| Shelf-life | 24–36 months |
| Certifications | WHO-GMP, EU-GMP, ISO, COPP |
| Manufacturer | Taj Pharma, Vapi, Gujarat, India |
Clinical Benefits and Usage Guidelines
Clinical Benefits:
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Reduces high blood pressure
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Manages edema from kidney, liver, or heart conditions
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Prevents potassium loss while acting as a diuretic
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Supports overall cardiovascular health
Usage Guidelines:
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Can be taken with or without food
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Take at the same time daily for best results
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Early daytime dosing may reduce nighttime urination
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Combine with lifestyle changes like regular exercise and low-sodium diet for maximum effect
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Monitor blood pressure and electrolytes regularly
Precautions:
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Inform your doctor about kidney, liver, or heart conditions
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Use cautiously during pregnancy or breastfeeding
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Limit salt or salt substitute intake
-
Follow doctor’s advice regarding fluid intake and monitoring
PCD Pharma Franchise Opportunities with Taj Pharma
Taj Pharma offers PCD Pharma Franchise opportunities for Spironolactone Tablets 25mg:
-
Monopoly rights for specific regions
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Marketing support and promotional materials
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Attractive profit margins
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Access to a wide range of cardiovascular and diuretic medicines
Top 20 FAQs
1. What is Spironolactone 25mg used for?
Treats hypertension, heart failure, edema, and hypokalemia.
2. Who is the manufacturer in India?
Taj Pharma, Vapi, Gujarat.
3. Are these tablets WHO-GMP certified?
Yes, fully certified.
4. How does Spironolactone work?
Increases urine output, conserves potassium, and reduces swelling.
5. What are common side effects?
Dizziness, headache, nausea, increased urination.
6. Is custom packaging available?
Yes, multi-language and private labeling options.
7. What is the shelf-life?
24–36 months.
8. Are these tablets exported globally?
Yes, to over 50 countries.
9. Can hospitals and distributors procure directly?
Yes, Taj Pharma caters to both.
10. Does Taj Pharma offer PCD franchise?
Yes, PAN India opportunities available.
11. Can it be taken with food?
Yes, but maintain consistency in administration.
12. Can it cause dizziness?
Yes, caution is advised while driving.
13. What dosage strengths are available?
25mg, 50mg, 100mg.
14. Does Taj Pharma provide bulk export solutions?
Yes, for hospitals, tenders, and distributors.
15. What export certifications are provided?
WHO-GMP, EU-GMP, COPP, CTD dossiers.
16. Is it safe during pregnancy?
Only if clearly needed and prescribed by a doctor.
17. What are the storage requirements?
Store below 25°C, dry, away from sunlight.
18. Does it require regular monitoring?
Yes, monitor blood pressure and electrolytes.
19. Can it be used for hormonal conditions?
Yes, in certain cases under medical supervision.
20. How to contact Taj Pharma?
Website: www.tajpharma.com, Email: info@tajpharma.com






