Candesartan Tablets

Candesartan Tablets

Candesartan Tablets
Each Film Coated Tablet Contains:
Candesartan Cilexitil 16 mg

Usage: – High blood pressure and heart failure

Category: – Anti Hypertensive / Cardiac drugs

Therapeutic category: – Hypertensive

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Description

Candesartan Cilexetil Tablets (8mg / 16mg / 32mg)

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

1. Product Introduction Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Candesartan Cilexetil Tablets in India. This Angiotensin II Receptor Blocker (ARB) is a potent antihypertensive agent known for its strong binding to receptors and long-lasting 24-hour effect. We produce high-purity tablets that ensure consistent blood pressure control and heart failure management. Our facility adheres to strict WHO-GMP standards. Healthy Inc manages our global exports and cardiology tenders.

2. Product Specifications | Parameter | Specification | | :— | :— | | Product Name | Candesartan Cilexetil Tablets | | Generic Name | Candesartan Cilexetil USP / BP / IP | | Strength | 4mg / 8mg / 16mg / 32mg | | Dosage Form | Uncoated Tablet (Scored available) | | Standard | USP / BP / IP Compliant | | Therapeutic Class | Angiotensin II Receptor Blocker (ARB) | | Shelf Life | 24 – 36 Months | | Packaging | 10×10 Alu-Alu Blister / 1000s Bulk Jar |

3. Manufacturing Candesartan 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. Candesartan Cilexetil is chemically sensitive to Hydrolysis (breakdown by water) and Thermal Degradation. To prevent this, we manufacture in Low-Humidity Suites (RH < 40%) and package the final tablets in Alu-Alu Blisters. This creates a near-perfect barrier against moisture and oxygen, ensuring the drug remains stable and effective even in tropical climates.

  • The Exporter: Healthy Inc Second, Healthy Inc manages international trade. This division handles logistics for Candesartan Tablets. We supply pharmacy chains and heart institutes globally. We offer scored tablets for the 16mg and 32mg strengths, allowing for precise dose titration as per the patient’s blood pressure response.

4. Quality Assurance We test every batch rigorously.

  • Polymorph Stability: Candesartan exists in different crystal forms. We ensure our API is the therapeutically active polymorph for optimal bioavailability.

  • Dissolution: We test how the tablet releases the drug. Because Candesartan is a prodrug, consistent release is vital for its conversion in the gut.

  • Related Substances: We monitor for degradation products to ensure safety over the full shelf life.

5. Why Use Candesartan Tablets? This drug blocks the “tightening” signal to blood vessels.

    • Mechanism: Candesartan Cilexetil is a prodrug. Once swallowed, it is converted into active Candesartan. It blocks the binding of Angiotensin II to the AT1 receptor.

    • Effect: Unlike ACE inhibitors, it blocks Angiotensin II completely, regardless of how it is produced. This relaxes blood vessels (lowering BP) and reduces the strain on the heart (Heart Failure).

    • Advantage: It has one of the strongest binding affinities among all ARBs, leading to sustained 24-hour control.

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Key Indications:

  • Hypertension: Treatment of high blood pressure in adults and children (1+ years).

  • Heart Failure: Treatment of heart failure (NYHA class II-IV) and patients with Left Ventricular Systolic Dysfunction (ejection fraction ≤ 40%).

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 Candesartan Tablets? A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

  • Q: Why Alu-Alu packaging? A: Candesartan is very sensitive to moisture. Clear blisters are not sufficient for long-term stability in export markets; Alu-Alu provides the necessary protection.

  • Q: Can this be combined with HCTZ? A: Yes, we also manufacture the combination of Candesartan + Hydrochlorothiazide (HCTZ) for patients needing extra BP control.

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

8. Dosage and Administration

  • Hypertension: Starting dose 16mg once daily. Maintenance range is 8mg to 32mg.

  • Heart Failure: Starting dose 4mg once daily. Target dose is 32mg once daily (titrated by doubling the dose every 2 weeks).

  • Administration: Can be taken with or without food.

9. Side Effects and Precautions

  • Hypotension: Dizziness or lightheadedness, especially in volume-depleted patients.

  • Hyperkalemia: Can increase potassium levels. Periodic monitoring of serum potassium is recommended.

  • Pregnancy: Contraindicated. Drugs acting on the renin-angiotensin system can cause injury and death to the developing fetus.

10. Storage Instructions

  • Store below 25°C in a dry place.

  • Moisture Sensitive: Keep strictly in the original Alu-Alu blister pack.

  • Keep out of reach of children.

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