Description

Clopidogrel and Aspirin Tablets (75mg + 75mg / 150mg)

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 Clopidogrel and Aspirin Tablets in India. This Dual Antiplatelet Therapy (DAPT) is the global standard for preventing blood clots in patients with Acute Coronary Syndrome (ACS) or those undergoing Percutaneous Coronary Intervention (PCI/Stents).

We offer Contract Manufacturing (Third Party) for this chemically complex formulation. Aspirin (Acetylsalicylic Acid) is acidic and can degrade Clopidogrel if mixed directly. Our WHO-GMP certified facility in Mumbai uses advanced Bilayer Tablet Technology or specialized coating techniques to physically separate the two active ingredients within a single tablet. This ensures maximum stability and efficacy over the shelf life. Healthy Inc manages the export logistics, supplying cardiac care centers and distributors worldwide.

2. Product Specifications

3. Manufacturing Clopidogrel + Aspirin

Manufacturing DAPT requires preventing chemical interaction between the two drugs.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  Moisture is the enemy of Aspirin (which hydrolyzes to acetic acid) and Clopidogrel (which degrades in acid). We use Low-Humidity Suites (< 20% RH) for processing. We often employ Enteric Coating for the Aspirin component to protect the stomach mucosa and ensure the drug releases in the intestine, while Clopidogrel is released immediately. This sophisticated release profile requires precise engineering.

• The Exporter: Healthy Inc

  Healthy Inc ensures that the product remains stable during transit. We use high-barrier Alu-Alu Cold Form Blisters which provide the highest level of protection against moisture and light. This is critical for preventing the “vinegar smell” associated with degraded Aspirin.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Related Substances: We strictly monitor for Salicylic Acid (Aspirin degradation) and Clopidogrel impurities to ensure safety.

• Dissolution: We perform multi-stage dissolution testing to verify that the Aspirin (if enteric-coated) resists acid and releases in the buffer stage, while Clopidogrel releases immediately.

• Assay: We ensure 100% label claim for both actives.

5. Why Use Clopidogrel + Aspirin?

Synergy saves lives.

• Mechanism:

  • Aspirin: Irreversibly inhibits the COX-1 enzyme, stopping thromboxane A2 production (which makes platelets sticky).

  • Clopidogrel: Blocks the P2Y12 ADP receptor on the platelet surface.

  • Result: Together, they provide a much stronger blockade against clot formation than either drug alone.

• Key Indications:

  • Post-Stent: Essential to prevent stent thrombosis (clotting inside the stent).

  • ACS: Management of Unstable Angina and Myocardial Infarction (Heart Attack).

  • Stroke Prevention: Secondary prevention of ischemic stroke.

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 Clopidogrel Aspirin Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India using stability-enhanced technology.

• Q: Why combine them in one tablet?

  A: “Pill burden” is a major issue for heart patients. Combining them ensures the patient doesn’t forget one of the two critical medicines.

• Q: Is the Aspirin enteric-coated?

  A: Yes, we usually manufacture with enteric-coated Aspirin to prevent gastric ulcers.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Standard Dosage: One tablet daily.

• Duration: Often prescribed for 12 months after stent implantation, then stepped down to monotherapy (as per cardiologist advice).

• Administration: Take with food to reduce stomach irritation.

9. Side Effects and Precautions

• Bleeding: The most common side effect is easy bruising or bleeding (nosebleeds).

• Stomach Pain: Gastritis or ulcers (reduced by enteric coating).

• Surgery: Must be stopped 5-7 days before any major surgery or dental work to prevent excessive bleeding.

10. Storage Instructions

• Store below 25°C in a dry place.

• Keep strictly away from moisture.