Alendronate Sodium Tablets 5mg

Alendronate Sodium Tablets   5mg Technical Specification:

GENERIC NAME OF THE MEDICINAL PRODUCT:

A) Alendronate Sodium Tablets USP 5mg
B) Alendronate Sodium Tablets USP 10mg
C) Alendronate Sodium Tablets USP 35mg
D) Alendronate Sodium Tablets USP 70mg

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A) Alendronate Sodium Tablets USP 5mg
Each uncoated tablet contains:
Sodium Alendronate USP
Equivalent to Alendronic Acid………5mg
Excipients……………………………………..q.s.

B) Alendronate Sodium Tablets USP 10mg
Each uncoated tablet contains:
Sodium Alendronate USP
Equivalent to Alendronic Acid………10mg
Excipients……………………………………..q.s.

C) Alendronate Sodium Tablets USP 35mg
Each uncoated tablet contains:
Sodium Alendronate USP
Equivalent to Alendronic Acid………35mg
Excipients……………………………………..q.s.

D) Alendronate Sodium Tablets USP 70mg
Each uncoated tablet contains:
Sodium Alendronate USP
Equivalent to Alendronic Acid………70mg
Excipients……………………………………..q.s.

THERAPEUTIC INDICATIONS:

Alendronate is used to prevent and treat certain types of bone loss (osteoporosis) in adults. Osteoporosis causes bones to become thinner and break more easily.

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.
Dosage: As directed by the Physician

Attach dispensing label as per end country.

Introduction to Alendronate Sodium Tablets 5mg

Alendronate Sodium Tablets 5mg are a trusted medication under the bisphosphonate class, widely prescribed for the treatment and prevention of osteoporosis caused by menopause, steroid use, or aging. They are also used to manage Paget’s disease of bone, a condition where bones grow larger and weaker than normal.

The medicine works by reducing bone turnover and inhibiting the activity of osteoclasts, which break down bone tissue. This strengthens the bones, alleviates pain, reduces fractures, and improves overall bone density.

Globally, osteoporosis is a significant health concern, especially among women post-menopause and elderly populations. With rising awareness and growing healthcare demands, the worldwide market for bisphosphonates such as Alendronate is expanding rapidly.

Taj Pharma, a WHO-GMP certified pharmaceutical company from Vapi, Gujarat, India, stands as a pioneer in the industry by offering Alendronate Sodium Tablets 5mg with assured purity, efficacy, and affordability, making it the top choice for global buyers, distributors, and PCD Pharma franchise partners.

In-depth Details for Importers, Exporters, and Buyers

1. Regulatory Documentation Provided

Taj Pharma simplifies the import-export process by offering all necessary regulatory paperwork, ensuring compliance across multiple jurisdictions:

• WHO-GMP & EU-GMP Certificates

• Certificate of Pharmaceutical Product (CoPP)

• Drug Master File (DMF)

• CTD/eCTD Dossier for registrations

• Stability studies as per ICH guidelines

• Free Sale Certificate (FSC)

2. Custom Packaging & Labeling

Global buyers receive tailored packaging solutions:

• Blister Packs (Alu-Alu, PVC/PVDC)

• HDPE bottles or jars

• Bulk packaging for institutional orders

• Custom branding & multilingual labeling as per import country requirements

3. Shelf-life, Storage, and Dosage Form

• Dosage Form: Film-coated tablet

• Strength: 5mg

• Shelf-life: 24–36 months

• Storage: Store below 25°C, away from heat and moisture

4. Export Certifications

Taj Pharma holds certifications and approvals recognized globally:

• WHO-GMP and EU-GMP Certified Facilities

• ISO 9001:2015 Certification

• CoPP for international registrations

• DMF submissions for regulatory support

• Halal certification (if required)

5. Target Countries & Export Markets

Taj Pharma has a strong export network spanning 40+ countries, including:

• Asia: Vietnam, Sri Lanka, Nepal, Philippines, Cambodia

• Africa: Nigeria, Kenya, Ghana, South Africa, Uganda

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

• Europe: Ukraine, Poland, Romania, Russia

• Latin America: Peru, Bolivia, Ecuador

By providing both bulk exports and retail-ready packs, Taj Pharma caters to government tenders, NGOs, hospitals, and private distributors.

Why is the Most Trusted Manufacturer, Supplier, and Exporter

1. State-of-the-Art Manufacturing

• Advanced WHO-GMP and EU-GMP certified facilities in Vapi, Gujarat

• Fully automated machinery and modern quality control systems

• Consistent batch-to-batch precision with stringent compliance checks

2. Affordable Pricing & Quality Assurance

• Competitive prices with uncompromised quality

• Adherence to IP/BP/USP/EP pharmacopoeial standards

• In-house R&D ensures formulation stability and bioequivalence

3. Global Presence & Supply Chain Support

• Strong export presence across Asia, Africa, Europe, and Latin America

• Seamless support in logistics, customs clearance, and regulatory compliance

• Long-standing partnerships with distributors, hospitals, and NGOs

4. Top 20 Export Countries

Nigeria, Kenya, South Africa, Vietnam, Philippines, Iraq, Libya, Uzbekistan, Ghana, Ethiopia, Yemen, Tanzania, Sri Lanka, Afghanistan, Myanmar, Nepal, Kazakhstan, Ecuador, Bangladesh, Dominican Republic

Technical Product Specification 

Call to Action for Buyers & Distributors

If you are a buyer, distributor, or PCD Pharma franchise partner looking for a reliable Alendronate Sodium Tablets 5mg manufacturer in India, Taj Pharma offers the perfect blend of quality, affordability, and global compliance.

📞 Contact Taj Pharma today to discuss export partnerships, bulk procurement, and franchise collaborations with guaranteed quality and on-time delivery.

Top 20 FAQs 

1. What are Alendronate Sodium Tablets 5mg used for?
They treat osteoporosis and Paget’s disease by strengthening bones and reducing fracture risks.

2. Who is the top manufacturer in India?
Taj Pharma, Vapi, Gujarat, is a leading WHO-GMP-certified manufacturer.

3. What certifications does Taj Pharma provide?
WHO-GMP, EU-GMP, ISO, CoPP, DMF dossiers.

4. Can these tablets be exported globally?
Yes, Taj Pharma exports to 40+ countries worldwide.

5. How should the tablets be taken?
On an empty stomach with water, as prescribed by the physician.

6. What are the common side effects?
Indigestion, headache, musculoskeletal pain, and diarrhea.

7. Are there serious side effects?
Yes—low calcium levels, kidney issues, and jaw pain (rare).

8. Can breastfeeding women take it?
Not recommended during breastfeeding.

9. Does Taj Pharma provide custom labeling?
Yes, with multilingual and country-specific packaging.

10. What is the shelf life?
24–36 months depending on packaging.

11. Which pharmacopoeias are followed?
IP/BP/USP/EP standards.

12. Can Taj Pharma support government tenders?
Yes, with full regulatory documentation and bulk supply.

13. What dosage strengths are available?
5mg, 35mg, and 70mg formulations.

14. Is it safe for kidney patients?
Use with caution; medical advice required.

15. Does Taj Pharma provide DMF dossiers?
Yes, in CTD/eCTD formats.

16. What are the target markets?
Asia, Africa, Middle East, Europe, Latin America.

17. How should it be stored?
Below 25°C in a dry environment.

18. Is Taj Pharma approved for WHO tenders?
Yes, with WHO-GMP certifications supporting NGO/government supplies.

19. Can buyers order bulk quantities?
Yes, bulk institutional and private supplies are available.

20. How can I contact Taj Pharma?
Via their official website or sales team for quotations and partnerships.

Taj Pharma has emerged as the leading Alendronate Sodium Tablets 5mg manufacturer in India, offering quality-driven, affordable, and WHO-GMP-certified medicines for global buyers. With state-of-the-art manufacturing, comprehensive export documentation, and a worldwide presence, Taj Pharma is the 1 choice for importers, distributors, and PCD Pharma franchise holders.

If you are searching for a reliable partner for Alendronate Sodium Tablets 5mg supply and exports, Taj Pharma is the global name you can trust.