Enalapril Tablets Manufacturer

Description

Enalapril Tablets (2.5mg / 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 manufacturer of Enalapril Maleate Tablets in India. Enalapril is an angiotensin-converting enzyme (ACE) inhibitor used in the management of hypertension and heart failure. Certain approved labels also include treatment of asymptomatic left ventricular dysfunction to reduce progression to symptomatic heart failure.

Enalapril is a prodrug converted in the body to the active metabolite enalaprilat. Manufacturing, packaging and stability controls are designed around the registered formulation and its known degradation pathways.

2. Product Specifications

3. Manufacturing Technology

• Stability Control: Enalapril Maleate can undergo degradation, including formation of enalaprilat and diketopiperazine-related products. Formulation, process conditions and moisture control are therefore established through product-specific development and validation.
• Compression: Direct compression or another validated manufacturing process may be used depending on the registered formula and excipient system.
• Packaging: Moisture-protective packaging such as cold-form blister may be selected where supported by stability studies. Zone IVb or other climatic-zone claims should be based on actual stability data.
• Content Uniformity: Low-dose and higher-strength products are controlled using validated blending and dosage-unit testing.

4. Quality Assurance

• Dissolution: Drug release is tested according to the applicable pharmacopoeial or registered method and acceptance criteria; a universal >80% in 30 minutes specification should not be assumed.
• Assay & Uniformity: Enalapril Maleate potency and dosage-unit uniformity are tested using validated methods.
• Related Substances: Relevant degradation products, including diketopiperazine-related impurities, are monitored according to the registered specification.
• Stability: Shelf life and storage conditions are supported by product-specific stability studies.

5. Pharmacology and Clinical Use

Enalapril is converted to enalaprilat, which inhibits ACE and reduces formation of angiotensin II. This decreases vasoconstriction and aldosterone-related effects, helping lower blood pressure and reduce cardiovascular workload.

• Hypertension: Used alone or with other antihypertensive therapy according to approved labeling and patient requirements.
• Heart Failure: Used as part of appropriate guideline-directed treatment in selected patients.
• Asymptomatic Left Ventricular Dysfunction: Included in certain approved prescribing information for selected patients to reduce progression to symptomatic heart failure and related outcomes.

6. Export and Regulatory Support

• Dossier Support: CTD / ACTD documentation where available for the specific product.
• Certificates: FSC, COPP and COA where applicable.
• Packaging: Market-specific packs according to registration and stability requirements.
• Logistics: Air or sea shipment via FOB Mumbai / CIF according to applicable requirements.

7. Frequently Asked Questions

Q: Who manufactures Enalapril Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Enalapril Maleate tablet formulations in India.

Q: Is this the same as Vasotec?
A: Vasotec is a brand containing Enalapril Maleate. Generic-equivalence or bioequivalence to a specific reference product should only be claimed when supported by the required product-specific regulatory evidence.

Q: Can Enalapril cause a dry cough?
A: Yes. A persistent dry cough can occur with ACE inhibitors and is associated with their pharmacologic effects, including increased bradykinin.

Q: What monitoring may be required?
A: Blood pressure, kidney function and serum potassium may require monitoring, particularly after starting treatment, changing dose or when clinical circumstances increase risk.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Individualized Dosing: Starting dose, titration, frequency and target dose depend on the indication, blood pressure, kidney function, concomitant medicines, volume status and the registered prescribing information.
• Renal Impairment: Dose or dosing interval may require adjustment depending on renal function.
• Administration: Enalapril tablets may generally be administered with or without food when permitted by the registered label.
• Monitoring: Clinical response, renal function and potassium should be assessed as appropriate.

9. Side Effects and Precautions

• Dry Cough: A persistent non-productive cough can occur.
• Hypotension: Symptomatic hypotension can occur, particularly in patients who are volume- or salt-depleted or receiving diuretics.
• Kidney Function: Serum creatinine can rise after ACE-inhibitor initiation. Particular caution is required in renal artery stenosis and other settings where renal perfusion is dependent on the renin-angiotensin system.
• Hyperkalemia: Potassium can increase; risk is greater with renal impairment and certain potassium-raising medicines or supplements.
• Angioedema: Swelling of the face, lips, tongue or airway can be life-threatening and requires urgent medical attention and discontinuation according to prescribing guidance.
• Pregnancy: Medicines acting on the renin-angiotensin system can cause fetal harm. Enalapril should be discontinued when pregnancy is detected and managed according to the applicable prescribing information and medical guidance.
• Drug Interactions: Relevant interactions can include potassium supplements/potassium-sparing medicines, diuretics, NSAIDs, lithium and other agents affecting blood pressure or renal function.

10. Storage Instructions

• Store below 25°C unless otherwise specified on the registered label.
• Protect from excessive heat and moisture.
• Keep in the original packaging and out of reach of children.