Spironolactone Tablets 50mg

Spironolactone Tablets 50mg 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 50mg

Spironolactone Tablets 50mg are a widely used diuretic (water pill) primarily prescribed for high blood pressure, heart failure, and edema associated with kidney, liver, or heart diseases. By promoting sodium and water excretion while retaining potassium, Spironolactone effectively reduces swelling and prevents complications related to fluid retention.

Apart from its role in managing hypertension and heart failure, Spironolactone 50mg is also employed in the treatment of hypokalemia (low potassium levels), a common electrolyte imbalance. Its safety profile, versatility, and effectiveness make it a globally in-demand therapeutic agent.

Taj Pharma, a trusted Spironolactone Tablets 50mg manufacturer in India, ensures high purity, precise dosage formulation, and consistent quality, catering to global buyers, distributors, hospitals, and PCD franchise partners.

In-Depth Details for Importers, Exporters & Buyers

For international buyers, smooth import procedures, regulatory compliance, and secure packaging are essential. Taj Pharma provides end-to-end solutions for the supply of Spironolactone Tablets 50mg worldwide.

Regulatory Documentation Provided

• WHO-GMP Certificate ensuring globally recognized manufacturing standards

• EU-GMP Certification for export compliance

• Certificate of Pharmaceutical Product (COPP) for global import approvals

• Complete CTD/eCTD Dossier

• Batch-wise Quality Control Reports and Stability Data

• Free Sale Certificate for smooth regulatory clearances

Custom Packaging & Labeling

• Blister packs, strips, and bulk bottles

• Tamper-proof, moisture-resistant packaging

• Private labeling options with multilingual printing

• Country-specific labeling compliant with local regulations

Shelf-Life, Storage & Dosage Form

• Shelf-life: 24–36 months

• Storage: Store below 25°C, in a dry place, away from direct sunlight

• Dosage form: Tablet, 50mg

Export Certifications

• WHO-GMP approved manufacturing facility

• EU-GMP certification for international standards

• ISO 9001:2015 certified

• DCGI and FDA-approved facilities

• Compliance with IP/BP/USP standards

Target Countries & Export Markets

Taj Pharma exports Spironolactone Tablets 50mg to more than 40 countries worldwide, including:

• Africa: Nigeria, Kenya, Ghana, South Africa

• Asia: Vietnam, Myanmar, Philippines, Cambodia

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

• Europe: Germany, France, Italy, Spain

• North & Latin America: USA, Canada, Mexico, Brazil

• CIS countries: Kazakhstan, Uzbekistan, Tajikistan

Why is the Most Trusted Manufacturer, Supplier & Exporter

Taj Pharma has become a leading Spironolactone Tablets 50mg manufacturer in India due to its commitment to quality, affordability, and global reach.

1. State-of-the-Art Manufacturing

• Facilities located in Vapi, Gujarat, equipped with WHO-GMP and EU-GMP certification

• Advanced production technology ensures accurate formulation, high purity, and consistency

• Rigorous QA/QC protocols guarantee batch-to-batch quality

2. Affordable Pricing & Quality Assurance

• Competitive pricing for both domestic and international buyers

• Strict compliance with IP/BP/USP pharmacopeial standards

• Quality assurance through state-of-the-art laboratories and testing equipment

3. Global Presence & Supply Chain Support

• PAN India distribution network

• Supplies hospitals, retail pharmacies, and PCD franchise partners

• Temperature-controlled logistics for sensitive products

• Full documentation support for hassle-free imports

4. Top 20 Countries Exporting Spironolactone Tablets 50mg

1. Nigeria

2. Kenya

3. Ghana

4. South Africa

5. Ethiopia

6. Vietnam

7. Myanmar

8. Philippines

9. Cambodia

10. UAE

11. Saudi Arabia

12. Iraq

13. Yemen

14. Germany

15. France

16. Italy

17. Spain

18. USA

19. Canada

20. Mexico

Technical Product Specification: 

Call to Action for Buyers, Distributors & PCD Franchise Partners

Taj Pharma is the 1 choice for Spironolactone Tablets 50mg supply worldwide. Whether you are a distributor, hospital, or PCD franchise partner, Taj Pharma offers:

• Reliable global export support

• Competitive pricing & flexible packaging

• Complete regulatory documentation for hassle-free imports

Top 20 FAQs on Spironolactone Tablets 50mg

Q1. What is Spironolactone Tablets 50mg used for?
A: It is used to treat high blood pressure, heart failure, edema, and hypokalemia.

Q2. Who is the leading Spironolactone Tablets 50mg manufacturer in India?
A: Taj Pharma, a WHO-GMP certified pharmaceutical company.

Q3. How does Spironolactone work?
A: It promotes sodium and water excretion while retaining potassium, reducing fluid retention and swelling.

Q4. Can Spironolactone be taken with food?
A: Yes, it can be taken with or without food. Consistency is key.

Q5. Are there any precautions during therapy?
A: Avoid excess salt substitutes and monitor kidney function regularly.

Q6. Is it safe during pregnancy or breastfeeding?
A: Only use if clearly needed; consult your healthcare provider.

Q7. Are regulatory dossiers provided for export?
A: Yes, including CTD/eCTD, COPP, and stability data.

Q8. Is private labeling available?
A: Yes, multilingual labeling options for international markets.

Q9. Minimum order quantity (MOQ)?
A: Based on buyer requirements and packaging specifications.

Q10. What is the shelf-life of Spironolactone 50mg tablets?
A: 24–36 months under recommended storage conditions.

Q11. Are bulk packaging options available?
A: Yes, blister packs, strip packs, and bottles are available.

Q12. Does Taj Pharma offer PCD Pharma Franchise?
A: Yes, globally for distributors and entrepreneurs.

Q13. Can it be exported worldwide?
A: Yes, Taj Pharma exports to over 40 countries.

Q14. Are there any dietary restrictions?
A: Limit intake of salt and potassium-rich foods unless advised otherwise.

Q15. Does Taj Pharma provide samples?
A: Yes, for verified buyers.

Q16. Are side effects common?
A: Minor side effects like dizziness, gastrointestinal upset, or menstrual irregularities may occur.

Q17. Is blood pressure monitoring required?
A: Yes, regular monitoring is recommended for efficacy and safety.

Q18. Can it be combined with other medications?
A: Yes, but inform your doctor about all current medications.

Q19. Where is Taj Pharma located?
A: Vapi, Gujarat, India, with PAN India distribution.

Q20. How to place bulk orders?
A: Contact Taj Pharma’s export division via email or website.