Alendronate Sodium Tablets 35mg

Alendronate Sodium Tablets 35mg 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 35mg

Alendronate Sodium Tablets 35mg belong to a class of medicines known as bisphosphonates. These tablets are widely prescribed to prevent or treat osteoporosis, particularly in postmenopausal women and individuals who use corticosteroids for long durations. Osteoporosis leads to weakened bones, increasing the risk of fractures. Alendronate plays a crucial role in regulating bone remodeling, reducing bone turnover, improving bone density, and minimizing fracture risks.

Additionally, it is used in the treatment of Paget’s disease of bone, a condition characterized by abnormal bone destruction and regrowth, leading to pain, deformity, and fragile bones.

Globally, the demand for Alendronate Sodium Tablets 35mg is rising due to the increasing incidence of osteoporosis in aging populations. According to WHO, osteoporosis is a major health concern worldwide, and bisphosphonates like Alendronate are considered first-line therapies.

This growing demand has positioned India, especially Taj Pharma from Vapi, Gujarat, as a trusted Alendronate Sodium Tablets 35mg manufacturer and supplier, catering to domestic and international pharmaceutical markets.

In-depth Details for Importers, Exporters, and Buyers

1. Regulatory Documentation Provided

Taj Pharma ensures compliance with all global regulatory standards by providing:

• WHO-GMP & EU-GMP certifications

• Certificate of Pharmaceutical Product (CoPP)

• Drug Master File (DMF)

• CTD/eCTD dossiers for regulatory submissions

• Stability data as per ICH guidelines

• Free Sale Certificate (FSC)

These documents support smooth regulatory approvals across multiple export markets.

2. Custom Packaging & Labeling

Taj Pharma provides customized packaging solutions for global buyers. Options include:

• Blister packs (Alu-Alu, PVC)

• Bottles and HDPE containers

• Bulk packaging for institutional supplies

• Customized branding and multilingual labeling as per country-specific regulatory needs

3. Shelf-life, Storage, and Dosage Form

• Dosage Form: Tablet, film-coated

• Strength: 35mg

• Shelf-life: 24 to 36 months depending on the packaging

• Storage: Store below 25°C in a cool, dry place away from moisture

4. Export Certifications

Taj Pharma is certified by globally recognized authorities. Key certifications include:

• WHO-GMP & EU-GMP approval

• ISO 9001:2015 certification

• CoPP & Free Sale Certificate

• Halal certification (if required)

• Regulatory compliance with US FDA, UK MHRA, TGA Australia (as applicable)

5. Target Countries & Export Markets

Taj Pharma has established a robust global footprint. Major export destinations include:

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

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

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

• Europe: Ukraine, Russia, Poland, Romania

• Latin America: Peru, Bolivia, Ecuador

With a strong logistics network, Taj Pharma ensures timely and secure delivery of pharmaceutical products to over 40+ countries worldwide.

Why is the Most Trusted Manufacturer, Supplier, and Exporter

Taj Pharma has built its reputation as a leading Alendronate Sodium Tablets 35mg manufacturer in India due to its commitment to quality, affordability, and global compliance.

1. State-of-the-Art Manufacturing

• WHO-GMP, EU-GMP, and ISO-certified facilities

• Advanced production units in Vapi, Gujarat

• Fully automated machinery ensuring precision and consistency

• Stringent quality control checks at every production stage

2. Affordable Pricing & Quality Assurance

• Competitive pricing due to economies of scale

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

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

3. Global Presence & Supply Chain Support

• Active exports to 40+ countries

• Comprehensive support for importers with regulatory documentation, logistics, and technical guidance

• Tailored solutions for government tenders, NGOs, hospitals, and private distributors

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 global buyer, distributor, or PCD Pharma franchise partner searching for a reliable Alendronate Sodium Tablets 35mg manufacturer in India, Taj Pharma is your trusted partner.

📞 Contact Taj Pharma today to explore export opportunities, bulk supply, or franchise collaborations at competitive prices with assured quality and timely delivery.

Top 20 FAQs 

1. What are Alendronate Sodium Tablets 35mg used for?
They are used to treat osteoporosis and Paget’s disease by strengthening bones and reducing fracture risks.

2. Who manufactures Alendronate Sodium Tablets 35mg in India?
Taj Pharma, Vapi, Gujarat is a leading WHO-GMP-certified manufacturer.

3. What certifications does Taj Pharma hold?
WHO-GMP, EU-GMP, ISO 9001:2015, CoPP, and DMF dossiers.

4. Can Alendronate Sodium Tablets 35mg be exported globally?
Yes, Taj Pharma exports to 40+ countries worldwide.

5. How should Alendronate be taken?
It should be taken on an empty stomach with water, as prescribed by the physician.

6. What are the common side effects?
Headache, muscle/joint pain, indigestion, and diarrhea.

7. What are serious side effects?
Kidney issues, low calcium, and jaw pain (osteonecrosis).

8. Is it safe during breastfeeding?
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 pharmacopoeia standards are followed?
IP/BP/USP/EP as per client requirement.

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

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

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

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

16. How is Alendronate stored?
Below 25°C, in a dry environment.

17. What is Taj Pharma’s USP?
Affordable, high-quality medicines with global regulatory compliance.

18. Does Taj Pharma provide DMF dossiers?
Yes, in CTD/eCTD formats for regulatory submissions.

19. Can buyers order in bulk?
Yes, bulk supplies are available for hospitals, NGOs, and distributors.

20. How can I contact Taj Pharma?
Through their official website or sales team for inquiries and orders.

Taj Pharma stands as the leading Alendronate Sodium Tablets 35mg manufacturer in India, trusted globally for its quality, affordability, and reliability. With WHO-GMP-certified facilities, strong export networks, and end-to-end regulatory support, Taj Pharma ensures seamless partnerships with global buyers, distributors, and PCD franchise holders.