Description

Losartan Potassium Tablets (25mg / 50mg / 100mg)

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 Losartan Potassium Tablets in India. Losartan is a premier Angiotensin II Receptor Blocker (ARB) used as a first-line treatment for Hypertension (High Blood Pressure), Diabetic Nephropathy (kidney disease in type 2 diabetics), and to reduce the risk of Stroke in patients with left ventricular hypertrophy.

We offer Contract Manufacturing (Third Party) services for this high-volume cardiovascular drug. Unlike ACE inhibitors, Losartan does not cause a dry cough, making it the preferred choice for many patients. Our WHO-GMP certified facility in Mumbai utilizes specialized moisture-controlled processing and packaging to handle the hygroscopic nature of the drug. Healthy Inc manages the export logistics, supplying cardiology centers and pharmacy chains across the USA, Europe, the Middle East, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Stability against moisture is the manufacturing priority.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Hygroscopicity Control: Losartan Potassium absorbs moisture from the air very easily, which can degrade the tablet. We manufacture the entire batch in Dehumidified Suites (RH < 40%) to ensure stability during compression.

  • Alu-Alu Packaging: To guarantee a 2-3 year shelf life in tropical climates, we predominantly use Cold Form Alu-Alu Blisters, which provide a 100% barrier against moisture and light.

  • Direct Compression: We use specialized free-flowing grades of the API and excipients like Microcrystalline Cellulose to form hard, stable tablets without the heat/moisture stress of wet granulation.

• The Exporter: Healthy Inc

  • Compliance: We offer serialization and aggregation on packaging for regulated markets (e.g., Track & Trace for exports), ensuring full supply chain visibility.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >75% 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 Azido impurities (mutagenic potential) to ensure compliance with the latest global safety alerts (FDA/EMA).

5. Why Use Losartan?

It blocks the pressure signal without the “Cough.”

• Mechanism: It selectively blocks the AT1 receptor for Angiotensin II. Normally, Angiotensin II constricts blood vessels and releases aldosterone. By blocking it, Losartan relaxes the vessels and lowers blood pressure.

• Key Indications:

  • Hypertension: Effective monotherapy or combined with HCTZ.

  • Diabetic Nephropathy: Slows the progression of kidney disease in patients with Type 2 Diabetes and hypertension (Renal Protection).

  • Stroke Reduction: Specifically approved to reduce the risk of stroke in patients with hypertension and an enlarged heart (LVH).

• Advantage: Excellent alternative for patients who cannot tolerate ACE Inhibitors (like Lisinopril) due to the persistent dry cough side effect.

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 Losartan Tablets?

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

• Q: Is it Cozaar?

  A: Cozaar is the brand name (Merck). We manufacture the Generic Equivalent (Losartan Potassium), which is bioequivalent.

• Q: Does it affect my potassium levels?

  A: Yes. It can cause Hyperkalemia (high potassium). Patients should avoid using salt substitutes containing potassium and have their blood levels checked regularly.

• Q: Is it safe for pregnancy?

  A: NO. Like all ARBs/ACEs, it carries a Black Box Warning for fetal toxicity. Stop immediately if pregnancy is detected.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Starting Dose: 50mg once daily.

• Maintenance: 25mg to 100mg daily (single or divided doses).

• Renal Protection (Diabetes): Start 50mg, increase to 100mg based on BP response.

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

9. Side Effects and Precautions

• Hyperkalemia: Risk increases with kidney issues or potassium supplements.

• Hypotension: Dizziness or lightheadedness, especially when standing up (Orthostatic Hypotension).

• Renal Function: Can cause acute kidney injury in patients with renal artery stenosis. Monitor serum creatinine.

• Angioedema: Swelling of face/lips (rare compared to ACEs, but possible).

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep container tightly closed. (Sensitive to moisture).