Spironolactone Tablets 100mg

Spironolactone Tablets 100mg Technical Specification:

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 100mg

Spironolactone Tablets 100mg are a widely used diuretic (water pill) that helps manage high blood pressure, heart failure, and edema caused by kidney, liver, or heart conditions. Spironolactone is also effective in treating hypokalemia (low potassium levels) and certain hormonal disorders like hyperaldosteronism.

Globally, Spironolactone Tablets 100mg are in high demand due to:

• Increasing prevalence of hypertension and heart failure

• Rising awareness about managing fluid retention and edema

• Preference for high-quality, WHO-GMP-certified diuretics

• Expanding healthcare and pharmaceutical infrastructure across emerging markets

Taj Pharma, a leading Spironolactone Tablets 100mg manufacturer in India, provides internationally certified, premium-quality tablets to hospitals, distributors, and export buyers worldwide.

In-Depth Details for Importers, Exporters, and Buyers

Regulatory Documentation Provided

Taj Pharma ensures full compliance with international pharmaceutical standards. For global buyers, the following documentation is provided:

• WHO-GMP and EU-GMP certificates

• Certificate of Pharmaceutical Product (COPP)

• CTD/eCTD dossiers for regulatory approvals

• Batch records, stability reports, and quality validation

• Free Sale Certificates for export markets

Custom Packaging & Labeling

• Private labeling and custom branding for distributors

• Multi-language packaging options for global markets

• Flexible packaging: blister packs, strip packs, bottles

• Compliant with international safety and transportation standards

Shelf-Life, Storage, and Dosage Form

• Dosage Strength: 100mg

• Dosage Form: Tablet

• Shelf-Life: 24–36 months

• Storage: Store below 25°C, in a dry place, protected from light

Export Certifications

• WHO-GMP, EU-GMP certified

• ISO 9001:2015 compliance

• COPP and CTD dossier documentation

• Stability and quality assurance reports

Target Countries & Export Markets

Taj Pharma exports Spironolactone Tablets 100mg to over 50 countries including:

• Asia: Nepal, Bangladesh, Sri Lanka, Vietnam

• Africa: Nigeria, Kenya, South Africa, Ghana

• Middle East: UAE, Saudi Arabia, Oman, Iraq

• Latin America: Peru, Colombia, Chile, Bolivia

• Europe & CIS: Russia, Kazakhstan, Uzbekistan, Kyrgyzstan

Why Taj Pharma is the Most Trusted Manufacturer/Supplier/Exporter

Taj Pharma’s reputation as a Spironolactone Tablets 100mg manufacturer in India is built on quality, affordability, and global reliability.

State-of-the-Art Manufacturing

• Advanced facility in Vapi, Gujarat

• WHO-GMP and EU-GMP-certified production

• In-house R&D and quality control laboratories

• Precision machinery for uniform, high-quality tablet production

Affordable Pricing & Quality Assurance

• Competitive pricing for bulk and retail orders

• Multi-step quality control for purity and potency

• High-quality Spironolactone tablets at cost-effective rates for international buyers

Global Presence & Supply Chain Support

• Reliable exports to over 50 countries

• On-time delivery with secure logistics

• Assistance for regulatory approvals and market registration

Top 20 Countries Exporting

1. Nepal

2. Bangladesh

3. Sri Lanka

4. Vietnam

5. Nigeria

6. Kenya

7. South Africa

8. Ghana

9. UAE

10. Saudi Arabia

11. Oman

12. Iraq

13. Peru

14. Colombia

15. Chile

16. Bolivia

17. Russia

18. Kazakhstan

19. Uzbekistan

20. Kyrgyzstan

Technical Product Specification Table

Clinical Benefits and Usage Guidelines

Clinical Benefits:

• Reduces high blood pressure

• Manages edema related to kidney, liver, or heart disorders

• Prevents hypokalemia by conserving potassium

• Improves overall cardiovascular health

Usage Guidelines:

• Can be taken with or without food

• Take at the same time each day for best results

• Early daytime dosing may reduce nighttime urination

• Lifestyle changes like regular exercise and low-sodium diet enhance effectiveness

• Regular monitoring of blood pressure and electrolytes is recommended

Precautions:

• Inform your doctor if you have kidney, liver, or heart conditions

• Avoid use during pregnancy or breastfeeding unless clearly needed

• Limit intake of salt or salt substitutes

• Monitor blood pressure and electrolyte levels frequently

PCD Pharma Franchise Opportunities with us

Taj Pharma offers PCD Pharma Franchise opportunities for Spironolactone Tablets 100mg:

• Monopoly rights for distributors in selected regions

• Marketing support and promotional materials

• Attractive profit margins

• Access to a wide range of cardiovascular and diuretic drugs

Top 20 FAQs on Spironolactone Tablets 100mg

1. What is Spironolactone 100mg used for?

Hypertension, heart failure, edema, 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, reduces swelling.

5. What are common side effects?

Dizziness, headache, nausea, increased urination.

6. Is custom packaging available?

Yes, multi-language and private labeling supported.

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 consistency in administration is important.

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?

Below 25°C, dry, away from sunlight.

18. Does it require regular monitoring?

Yes, blood pressure and electrolytes must be monitored.

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