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Alendronate Tablets

Alendronate Tablets

Alenfos
Alendronate Tablets 70 mg

Each tablet contains :
Alendronate Sodium
Eq. To Alendronate Sodium anhydrous 70 mg

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Description

Alendronate Sodium Tablets (10mg / 70mg)

Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc

1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Alendronate Sodium Tablets in India. This Bisphosphonate is the global standard for treating and preventing Osteoporosis. We produce both the daily (10mg) and the convenient once-weekly (70mg) formulations. Our facility adheres to strict WHO-GMP standards. Therefore, we guarantee consistent potency for bone health programs. Healthy Inc manages our global exports and hospital tenders.

2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Alendronate Sodium Tablets | | Generic Name | Alendronate Sodium USP / BP / IP | | Strength | 10mg (Daily) / 35mg / 70mg (Weekly) | | Dosage Form | Film Coated Tablet | | Standard | USP / BP / IP Compliant | | Therapeutic Class | Bisphosphonate / Osteoporosis Agent | | Shelf Life | 36 Months | | Packaging | 1×4 Blister (Monthly Pack) / 10×10 Blister |

3. Manufacturing Alendronate Sodium Tablets We divide our operations to ensure specialized focus.

  • The Manufacturer: Healthy Life Pharma Pvt. Ltd. First, Healthy Life Pharma handles manufacturing. We operate a WHO-GMP certified plant in Mumbai. Alendronate can cause severe irritation if it dissolves in the throat or esophagus. To prevent this, we use a specialized Film Coating. This ensures the tablet surface is smooth and slippery for easy swallowing. We also optimize the Disintegration Time so the tablet remains intact until it reaches the stomach but dissolves rapidly once there for absorption.

  • The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Alendronate Sodium Tablets. We supply geriatric care centers and pharmacies globally. We offer specialized “Calendar Packaging” (blisters marked with Day 1, Day 2, etc.) for the 70mg Weekly dose to help patients remember their schedule.

4. Quality Assurance We test every batch rigorously.

  • Assay Verification: We use HPLC testing. This confirms the Alendronate content is exact.

  • Dissolution: We test how the tablet releases the drug. Bisphosphonates have poor oral bioavailability (<1%), so the tablet must dissolve perfectly to work at all.

  • Uniformity of Dosage Units: We ensure every tablet has the same weight and drug content.

5. Why Use Alendronate Sodium Tablets? This drug increases bone density and reduces fracture risk.

  • Mechanism: It works by inhibiting osteoclasts (the cells that break down bone). This allows the bone-building cells (osteoblasts) to rebuild bone mass effectively.

  • Effect: It significantly reduces the risk of hip and spine fractures.

Key Indications:

  • Treatment of Postmenopausal Osteoporosis (70mg Weekly).

  • Treatment of Osteoporosis in men.

  • Prevention of Steroid-induced Osteoporosis.

  • Treatment of Paget’s Disease of bone (40mg Daily).

6. Export and Regulatory Support We provide complete documentation for registration.

  • Dossier: We offer CTD and ACTD formats.

  • Certificates: We supply the Free Sale Certificate (FSC) and COPP.

  • Logistics: We ship via FOB Mumbai or CIF.

7. Frequently Asked Questions

  • Q: Who manufactures Alendronate Sodium Tablets? A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

  • Q: Which strength is most popular? A: The 70mg Once Weekly tablet is the most popular because it is more convenient for patients than taking a pill every day.

  • Q: Are these coated? A: Yes, all our Alendronate tablets are film-coated to aid swallowing and safety.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION (For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

  • Osteoporosis Treatment: 70mg once a week OR 10mg once daily.

  • Administration (Critical):

    1. Take with a full glass of plain water only (no coffee, juice, or mineral water) first thing in the morning.

    2. Do not lie down for at least 30 minutes after taking it.

    3. Do not eat or drink anything else for at least 30 minutes.

  • Reason: This ensures the tablet reaches the stomach safely and absorbs properly.

9. Side Effects and Precautions

  • Common Side Effects: Abdominal pain, acid reflux, or nausea.

  • Esophageal Warning: Stop use if you experience difficulty swallowing or chest pain.

  • Jaw Health: Rare risk of Osteonecrosis of the Jaw (ONJ), mostly in cancer patients. Good dental hygiene is recommended.

10. Storage Instructions

  • Store below 25°C in a dry place.

  • Protect from moisture.

  • Keep out of reach of children.

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