Description
Amlodipine Tablets (5mg / 10mg)
Manufactured by Healthy Life Pharma Pvt. Ltd. | Exported by Healthy Inc
1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Amlodipine Tablets in India. This Calcium Channel Blocker (CCB) is one of the most widely prescribed medications globally for the long-term management of Hypertension and Angina. We produce high-purity Amlodipine Besylate tablets that ensure consistent 24-hour blood pressure control. Our facility adheres to strict WHO-GMP standards. Healthy Inc manages our global exports and cardiology tenders.
2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Amlodipine Tablets | | Generic Name | Amlodipine Besylate USP / BP / IP | | Strength | 2.5mg / 5mg / 10mg | | Dosage Form | Uncoated Tablet (Scored available) | | Standard | USP / BP / IP Compliant | | Therapeutic Class | Calcium Channel Blocker (Dihydropyridine) | | Shelf Life | 36 Months | | Packaging | 10×10 Amber Blister / 10×10 Alu-Alu Blister |
3. Manufacturing Amlodipine 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. Amlodipine is highly sensitive to light (photolabile). If exposed to UV light, it degrades into inactive impurities. To prevent this, we manufacture under Controlled Light Conditions and use Amber (UV-Blocking) PVC or Alu-Alu packaging. We also use advanced blending technology to ensure “Content Uniformity,” guaranteeing that every 5mg tablet contains exactly 5mg of drug, which is vital for low-dose potent actives.
The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Amlodipine Tablets. We supply pharmacy chains and government health depots globally. We offer scored tablets (break-lines) for the 10mg strength, allowing for easy dose titration for elderly patients.
4. Quality Assurance We test every batch rigorously.
Photostability Testing: We stress-test the final packaging to ensure the drug remains stable even if the box is left in the sun during transport.
Dissolution: We test how the tablet releases the drug. Amlodipine must release slowly and consistently to provide smooth blood pressure reduction without causing sudden hypotension.
Related Substances: We monitor for pyridine analogs (degradation products) to ensure safety.
5. Why Use Amlodipine Tablets? This drug relaxes the blood vessels.
Mechanism: It inhibits the influx of calcium ions into vascular smooth muscle and cardiac muscle. This causes the arteries to dilate (widen).
Effect: It lowers peripheral vascular resistance (lowering blood pressure) and improves blood flow to the heart (relieving Angina).
Key Indications:
Hypertension: First-line treatment for high blood pressure (can be used alone or with other agents).
Chronic Stable Angina: Prevention of chest pain due to exertion.
Vasospastic Angina (Prinzmetal’s): Treatment of spasms in the coronary arteries.
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 Amlodipine Tablets? A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.
Q: Is this the Besylate salt? A: Yes, we use Amlodipine Besylate, which is the global standard salt form (equivalent to the innovator Norvasc) due to its superior stability compared to Maleate.
Q: Can you supply combination tablets? A: Yes, we also manufacture Amlodipine + Atenolol and Amlodipine + Lisinopril combinations.
CLINICAL PHARMACOLOGY & SAFETY INFORMATION (For Registered Medical Practitioners & Patient Reference)
8. Dosage and Administration
Standard Dosage: Starting dose is usually 5mg once daily. Can be increased to 10mg.
Elderly: Starting dose of 2.5mg is often recommended.
Administration: Can be taken without regard to meals. It has a long half-life (30-50 hours), so once-daily dosing is sufficient.
9. Side Effects and Precautions
Pedal Edema: The most common side effect is swelling of the ankles (edema). This is dose-dependent.
Palpitations: Mild flushing or rapid heartbeat may occur initially.
Gingival Hyperplasia: Rare cases of gum overgrowth with long-term use. Good dental hygiene is recommended.
10. Storage Instructions
Store below 25°C in a dry place.
Critical: Protect from light. Keep tablets in the blister until immediately before use.
Keep out of reach of children.
