Description

Imidapril Hydrochloride Tablets (5mg / 10mg / 20mg)

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 Imidapril Hydrochloride Tablets in India. Imidapril is a long-acting, non-sulfhydryl Angiotensin-Converting Enzyme (ACE) Inhibitor. It is primarily used for the treatment of Essential Hypertension and is clinically distinct for its efficacy in treating Diabetic Nephropathy (specifically in Type 1 diabetics), where it helps slow the progression of kidney disease.

We offer Contract Manufacturing (Third Party) services for this specialized cardiovascular drug. Imidapril is a prodrug that is highly sensitive to hydrolysis (breakdown by water). Our WHO-GMP certified facility in Mumbai utilizes controlled low-humidity manufacturing suites and Dry Granulation techniques to prevent degradation during processing. Healthy Inc manages the export logistics, supplying cardiology and nephrology centers across Southeast Asia, the Middle East, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Stabilizing a moisture-sensitive prodrug.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Hydrolysis Prevention: Imidapril readily converts to its diketopiperazine degradation product if exposed to moisture. We strictly control the Relative Humidity (RH) < 30% in our compression suites and use excipients with low moisture content.

  • Alu-Alu Packaging: To guarantee stability in tropical climates (Zone IVb), we exclusively recommend Cold Form Alu-Alu Blisters, which provide a near-perfect barrier against moisture ingress.

  • Prodrug Formulation: The tablet is formulated to ensure the prodrug remains intact until ingestion, where it is rapidly absorbed and converted by the liver into the active metabolite, Imidaprilat.

• The Exporter: Healthy Inc

  • Regional Compliance: Imidapril is widely used in Asian markets (Japanese origin). We offer dossiers compliant with JP (Japanese Pharmacopoeia) and ASEAN standards to facilitate registration in these specific regions.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes.

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

• Impurity Profiling: We strictly monitor for the specific degradation impurity (Imidapril Diketopiperazine) to ensure the drug remains effective and safe.

5. Why Use Imidapril?

Renal protection without the sulfur taste.

• Mechanism: Imidapril blocks the Angiotensin-Converting Enzyme (ACE). This prevents the conversion of Angiotensin I to Angiotensin II (a potent vasoconstrictor). The result is relaxed blood vessels and reduced blood pressure.

• Key Indications:

  • Hypertension: Effective reduction of blood pressure with once-daily dosing.

  • Diabetic Nephropathy (Type 1): Uniquely indicated for delaying kidney damage in patients with Type 1 Diabetes and microalbuminuria.

• Advantage: Unlike Captopril, it lacks a sulfhydryl group, meaning it rarely causes taste disturbances or skin rashes. It has high lipophilicity (fat solubility), allowing excellent tissue penetration.

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 Imidapril Tablets?

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

• Q: Is it Tanatril?

  A: Tanatril is the brand name (Mitsubishi Tanabe). We manufacture the Generic Equivalent (Imidapril HCl).

• Q: Does it cause a cough?

  A: Yes. Like all ACE inhibitors, it can cause a persistent dry cough in some patients due to the accumulation of Bradykinin in the lungs.

• Q: Is it safe for pregnancy?

  A: NO. Black Box Warning: Drugs affecting the RAAS system can cause injury and death to the developing fetus. Stop immediately if pregnancy is detected.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Hypertension: Start with 5mg once daily. Maintenance 10mg daily (Max 20mg).

• Diabetic Nephropathy: 5mg to 10mg once daily.

• Timing: Take about 15 minutes before meals (food can slightly reduce absorption).

9. Side Effects and Precautions

• Dry Cough: A tickling, non-productive cough.

• Hypotension: “First-dose effect” causing dizziness. Start low in volume-depleted patients.

• Hyperkalemia: Can raise potassium levels. Monitor K+ levels, especially if taking potassium supplements.

• Angioedema: Rare but serious swelling of the face/lips/tongue.

10. Storage Instructions

• Store below 25°C in a dry place.

• Extremely Sensitive to Moisture. Keep in the original blister pack until use.