Description

Telmisartan Tablets (20mg – 80mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Telmisartan Tablets in India. Telmisartan is a premier Angiotensin II Receptor Blocker (ARB) widely utilized for the management of Essential Hypertension and for Cardiovascular Risk Reduction in patients unable to take ACE inhibitors.

We offer Contract Manufacturing (Third Party) services for this high-volume chronic therapy. Telmisartan is distinguished by its 24-hour long half-life, the longest of any ARB, ensuring consistent blood pressure control around the clock. Our WHO-GMP certified facility in Mumbai utilizes advanced moisture-controlled processing suites to handle this hygroscopic drug. Healthy Inc manages the export logistics, ensuring the product reaches markets in the EU, Latin America, Southeast Asia, and CIS countries in optimal condition.

2. Product Specifications

3. Manufacturing Technology

Telmisartan requires specific formulation strategies due to its solubility and sensitivity.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Solubility Enhancement: Telmisartan is practically insoluble in water at physiological pH. We utilize Alkalizing Agents (like Sodium Hydroxide or Meglumine) and spray-drying or fluid-bed granulation techniques to create a formulation that dissolves rapidly in the stomach.

  • Moisture Control: The API is hygroscopic (absorbs moisture). We manufacture in Dehumidified Suites (< 30% RH) to prevent the tablet from becoming soft or chemically degrading.

  • Compression: We use specialized tooling to ensure tablets are compressed to a hardness that withstands handling but still disintegrates within minutes.

• The Exporter: Healthy Inc

  • High-Barrier Packaging: We exclusively use Alu-Alu Cold Form Blisters for Telmisartan. This provides a 100% barrier against moisture and light, which is non-negotiable for the stability of this specific molecule in tropical climates.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles in multiple pH media (1.2, 4.5, 6.8) to validate that the solubility enhancement technology is working effectively.

• Assay: We ensure 100% label claim (90-110%) using validated HPLC methods.

• Impurities: We strictly monitor for degradation products to ensure safety over the 3-year shelf life.

5. Why Use Telmisartan?

It offers superior 24-hour control.

• Mechanism: It selectively blocks the binding of Angiotensin II to the AT1 receptor, relaxing blood vessels and reducing the secretion of aldosterone.

• Key Indications:

  • Hypertension: Lowers high blood pressure.

  • Cardiovascular Risk Reduction: Prevention of heart attack and stroke in high-risk patients (ages 55+) who cannot tolerate ACE inhibitors.

• Advantage: Unlike shorter-acting drugs (like Losartan), Telmisartan covers the critical early morning hours when blood pressure surges are most dangerous.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Telmisartan Tablets?

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

• Q: Is Telmisartan better than Losartan?

  A: Telmisartan has a much longer half-life (24 hours vs. 6-9 hours for Losartan), meaning a missed dose is less critical, and it provides smoother BP control throughout the day and night.

• Q: Does it cause a cough?

  A: No. Unlike ACE inhibitors (e.g., Ramipril), Telmisartan does not affect bradykinin levels and therefore rarely causes a dry cough.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: 40mg once daily. Can be titrated to 80mg if BP is not controlled.

• Administration: Swallow whole with water. Can be taken with or without food.

• Hepatic Impairment: Use lower doses (max 40mg) in patients with mild-to-moderate liver issues.

9. Side Effects and Precautions

• Common Side Effects: Dizziness, back pain, and sinus congestion.

• Hyperkalemia: Telmisartan can raise potassium levels. Avoid potassium supplements.

• Hypotension: Watch for low blood pressure, especially in volume-depleted patients (those on diuretics).

• Pregnancy: Black Box Warning: Drugs acting on the renin-angiotensin system can cause injury and death to the developing fetus. Do not use in pregnancy.

10. Storage Instructions

• Store below 25°C in a dry place.

• Tablets are hygroscopic. Do not remove from the blister until immediately before administration.