Description

Amlodipine and Losartan Potassium Tablets

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 Amlodipine and Losartan Potassium Tablets in India. This is a highly effective Antihypertensive Combination that pairs two of the most trusted classes of blood pressure medications: Amlodipine (a Calcium Channel Blocker) and Losartan Potassium (an Angiotensin II Receptor Blocker – ARB).

We offer Contract Manufacturing (Third Party) services for this Fixed-Dose Combination (FDC). Unlike combinations containing ACE inhibitors, this formulation offers similar efficacy but with a significantly lower risk of dry cough, improving patient adherence. Our WHO-GMP certified facility in Mumbai utilizes advanced moisture-control technology to stabilize the Losartan Potassium, which is hygroscopic. Healthy Inc manages the export logistics, supplying this essential cardiovascular medicine to pharmacy chains and hospitals across the USA, Latin America, Southeast Asia, and Africa.

2. Product Specifications

3. Manufacturing Technology

Combining a CCB with a hygroscopic ARB requires specific expertise.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Moisture Management: Losartan Potassium is hygroscopic (absorbs moisture readily). We manufacture these tablets in Dehumidified Suites (< 30% RH) to prevent the tablet from becoming soft or degrading.

  • Stability: Amlodipine Besylate is sensitive to light. We use opaque Film Coating (Opadry) materials to protect the core tablet from light exposure and moisture ingress.

  • Content Uniformity: We employ Geometric Mixing and high-shear granulation to ensuring the 5mg dose of Amlodipine is perfectly distributed within the bulk of Losartan, guaranteeing consistent blood pressure control.

• The Exporter: Healthy Inc

  • Packaging: We strongly recommend Alu-Alu Cold Form Blisters for this product. This provides the highest level of protection against humidity in tropical export markets, ensuring the Losartan remains stable and effective.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Assay: We use validated HPLC methods to simultaneously quantify both active ingredients, ensuring they meet the 90-110% potency requirement.

• Dissolution: We test the release profile to confirm that >80% of both drugs release within 30-45 minutes.

• Impurity Profiling: We strictly monitor for Losartan Azido impurity and Amlodipine oxidative impurities to ensure patient safety over the shelf life.

5. Why Use Amlodipine + Losartan?

It offers powerful BP reduction with excellent tolerability.

• Mechanism:

  • Amlodipine: Relaxes the smooth muscles of the arterial walls, improving blood flow.

  • Losartan: Blocks the action of Angiotensin II (a potent vasoconstrictor) at the receptor level, relaxing blood vessels and preventing salt retention.

• Key Advantages:

  • No Dry Cough: Unlike Lisinopril or Enalapril (ACE inhibitors), Losartan (ARB) rarely causes a dry cough.

  • Reduced Edema: Losartan dilates veins, which helps drain the fluid accumulation in the ankles often caused by Amlodipine.

  • Kidney Protection: Losartan offers renal protection, making this combo ideal for hypertensive diabetics.

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 Amlodipine Losartan Tablets?

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

• Q: Is this better than Amlodipine alone?

  A: Yes, clinical trials show that the combination lowers blood pressure significantly more than increasing the dose of Amlodipine alone, and with fewer side effects like swelling.

• Q: Can I take this with food?

  A: Yes, both Amlodipine and Losartan can be taken with or without food.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: One tablet daily.

• Titration: Treatment usually starts with the 5mg/50mg strength and can be titrated up after 2-4 weeks if BP targets are not met.

• Administration: Swallow whole with water.

9. Side Effects and Precautions

• Common Side Effects: Dizziness (especially upon standing up), headache, and mild ankle swelling (less than Amlodipine alone).

• Hyperkalemia: Losartan can raise potassium levels. Periodic monitoring is advised.

• Pregnancy: Black Box Warning: Drugs acting on the renin-angiotensin system (like Losartan) can cause injury and death to the developing fetus. Do not use in pregnancy.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep strictly protected from moisture.