Description

Ramipril Tablets (1.25mg – 10mg)

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 Ramipril Tablets in India. Ramipril is a premier Angiotensin-Converting Enzyme (ACE) Inhibitor, widely prescribed for the treatment of Hypertension (High Blood Pressure) and Heart Failure, and for the reduction of the risk of myocardial infarction and stroke in high-risk patients.

We offer Contract Manufacturing (Third Party) services for this highly sensitive cardiovascular drug. Ramipril is susceptible to degradation by moisture and mechanical stress. Our WHO-GMP certified facility in Mumbai utilizes low-shear granulation and specialized packaging lines to ensure the stability of the active ingredient. Healthy Inc manages the export logistics, supplying pharmacy chains and cardiology centers across Europe, the Middle East, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Stability is the primary formulation challenge.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Hydrolysis Prevention: Ramipril degrades rapidly into Ramiprilat (active but unstable) and Diketopiperazine (inactive impurity) if exposed to moisture or heat. We manufacture in Dehumidified Suites (< 30% RH) and strictly control the water content of excipients.

  • Low-Stress Processing: High compression force can trigger degradation. We use specialized tooling and direct compression or dry granulation techniques to minimize physical stress on the molecule.

  • Content Uniformity: For low doses (1.25mg), we use high-precision blending to ensure perfectly even distribution of the drug in every tablet.

• The Exporter: Healthy Inc

  • Alu-Alu Packaging: We exclusively recommend Alu-Alu Cold Form Blisters for export. This provides a near-perfect barrier against moisture, which is non-negotiable for the shelf-life stability of Ramipril in tropical climates.

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 Ramipril Diketopiperazine (impurity D) to ensure it stays below pharmacopoeial limits (usually < 0.5%).

5. Why Use Ramipril?

It provides “Cardioprotection” beyond just lowering blood pressure.

• Mechanism: It inhibits the ACE enzyme, preventing the conversion of Angiotensin I to Angiotensin II (a potent vasoconstrictor). This relaxes blood vessels and reduces the workload on the heart.

• Key Indications:

  • Hypertension: First-line treatment.

  • Heart Failure: Improves survival after a heart attack.

  • Nephropathy: Slows the progression of kidney disease in diabetic and non-diabetic patients.

• Advantage: Unlike some other blood pressure meds, Ramipril has strong evidence for reducing the risk of death in high-risk cardiovascular patients (HOPE Study).

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers (with Stability Data) 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 Ramipril Tablets?

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

• Q: Why does it cause a cough?

  A: ACE inhibitors block the breakdown of Bradykinin in the lungs. This accumulation causes a dry, tickly cough in about 10-20% of patients. If intolerable, doctors often switch to an ARB (like Telmisartan).

• Q: Is it safe for kidneys?

  A: It is actually protective for kidneys in the long run (reducing protein in urine), but can cause acute issues in dehydrated patients. Renal function should be monitored.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Hypertension: Initial 2.5mg once daily. Maintenance 5mg to 10mg daily.

• Heart Failure: Initial 1.25mg once daily, titrated up slowly.

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

9. Side Effects and Precautions

• Dry Cough: Persistent, non-productive cough.

• Hyperkalemia: Can raise potassium levels. Avoid potassium supplements.

• Angioedema: Swelling of the face/lips/tongue. This is a medical emergency. Stop drug immediately.

• Pregnancy: Black Box Warning: Contraindicated in pregnancy (can cause fetal injury/death).

10. Storage Instructions

• Store below 25°C in a dry place.

• Tablets are highly hygroscopic. Do not remove from blister until use.