Description

Indapamide Tablets (1.5mg SR / 2.5mg)

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 Indapamide Tablets in India. Indapamide is a “Thiazide-Like” Diuretic that is chemically distinct because it possesses a dual mechanism of action: it acts as a diuretic (removing salt) and a direct Vasodilator. It is a first-line treatment for Essential Hypertension (high blood pressure) and is particularly valued for its Metabolic Neutrality—unlike older diuretics, it does not negatively affect blood sugar or cholesterol levels, making it ideal for diabetic or dyslipidemic patients.

We offer Contract Manufacturing (Third Party) services for both the classic 2.5mg Immediate Release and the advanced 1.5mg Sustained Release (SR) formulations. Our WHO-GMP certified facility in Mumbai utilizes specialized Hydrophilic Matrix Technology for the SR tablets, ensuring a steady, 24-hour release profile that provides smooth blood pressure control without the “peaks and troughs” of older drugs. Healthy Inc manages the export logistics, supplying cardiology centers and pharmacy chains across Europe, Southeast Asia, and the Middle East.

2. Product Specifications

3. Manufacturing Technology

Dual action through advanced formulation.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • SR Matrix Technology: For the 1.5mg SR tablet, we disperse the Indapamide in a Hypromellose (HPMC) Matrix. When ingested, this matrix forms a gel layer that regulates the release of the drug over 24 hours. This technology is critical for ensuring “Through-to-Peak” ratios that meet regulatory standards for once-daily dosing.

  • Solid Dispersion: Indapamide is poorly soluble in water. We use solid dispersion techniques during granulation to ensure the drug dissolves completely in the gut, maximizing bioavailability.

  • Stability: We process the drug in humidity-controlled zones and use moisture-barrier packaging to prevent hydrolysis over the 3-year shelf life.

• The Exporter: Healthy Inc

  • Stroke Prevention Kits: We can bundle Indapamide with Perindopril (ACE Inhibitor) packaging, as this specific combination is the gold standard for stroke prevention (PROGRESS trial data).

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution (SR): We test release profiles at 2, 6, and 12 hours to guarantee sustained release behavior.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Uniformity: We ensure precise dosing, as small variations in this potent diuretic can lead to electrolyte imbalances.

5. Why Use Indapamide?

It lowers pressure without raising sugar or cholesterol.

• Mechanism 1 (Diuretic): Like thiazides, it acts on the Distal Convoluted Tubule of the kidney to excrete sodium and water, reducing blood volume.

• Mechanism 2 (Vasodilation): Unlike standard thiazides, Indapamide regulates Calcium influx in the smooth muscle cells of blood vessels. This relaxes the arteries (vasodilation) and lowers peripheral resistance.

• Key Indications:

  • Essential Hypertension: Effective monotherapy or combined with ACE inhibitors/CCBs.

  • Edema: Fluid retention due to heart failure.

• Advantage: It is “Metabolically Neutral,” meaning it causes minimal disturbance to glucose and lipid metabolism, unlike Hydrochlorothiazide.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers (with Bioequivalence Studies for SR) 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 Indapamide Tablets?

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

• Q: Is it Natrilix SR?

  A: Natrilix SR is the brand name (Servier). We manufacture the Generic Equivalent (Indapamide SR), which offers the same 24-hour control.

• Q: Does it cause low potassium?

  A: Yes. Hypokalemia (low potassium) is a side effect. Patients should have blood tests regularly or eat potassium-rich foods.

• Q: Can I take it if I have a sulfa allergy?

  A: Caution. Indapamide is a sulfonamide derivative. While cross-reactivity is rare, it should be used with caution in patients with severe sulfa allergies.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Hypertension: 1.5mg SR once daily OR 2.5mg IR once daily.

• Timing: Best taken in the morning to avoid night-time urination (nocturia).

• Administration: Swallow SR tablets whole. Do not crush or chew.

9. Side Effects and Precautions

• Electrolytes: Hypokalemia (low potassium) and Hyponatremia (low sodium). Monitor regularly.

• Dizziness: Postural hypotension, especially in elderly patients.

• Photosensitivity: Use sunscreen as skin may burn more easily.

• Renal: Safe in patients with mild to moderate kidney issues, but ineffective in severe renal failure.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed.