Description

Clopidogrel Tablets (75mg / 300mg)

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 Bisulfate Tablets in India. Clopidogrel is a premier Antiplatelet Agent (P2Y12 Inhibitor) used globally to prevent atherothrombotic events such as Myocardial Infarction (Heart Attack), Stroke, and Stent Thrombosis in patients with Acute Coronary Syndrome (ACS). It is the standard of care for patients undergoing Angioplasty (PCI).

We offer Contract Manufacturing (Third Party) services for this life-saving cardiovascular drug. Clopidogrel is chemically sensitive to moisture and exists in different polymorphic forms. Our WHO-GMP certified facility in Mumbai exclusively utilizes the stable Polymorph Form II of Clopidogrel Bisulfate and employs Dry Granulation techniques to prevent hydrolytic degradation. Healthy Inc manages the export logistics, supplying cardiology centers, cath labs, and pharmacy chains across the USA, Europe, and Latin America.

2. Product Specifications

3. Manufacturing Technology

Ensuring potency in every heartbeat.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Polymorph Stability: Clopidogrel exists as Form I (kinetically unstable) and Form II (thermodynamically stable). We strictly manufacture using Form II API to ensuring the drug does not change crystal structure on the shelf, which guarantees consistent bioavailability.

  • Moisture Defense: Clopidogrel degrades rapidly into impurities when exposed to humidity. We use Low-Moisture Excipients and Cold Form Alu-Alu Blisters to create an impermeable barrier against environmental moisture.

  • Coating Integrity: We use a specialized Opadry II (PVA-based) film coating system that provides a robust moisture barrier while ensuring rapid disintegration in the stomach.

• The Exporter: Healthy Inc

  • Loading Dose Packs: We can supply single-tablet blister packs of 300mg, essential for emergency room “Loading Doses” administered immediately upon diagnosis of a heart attack.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >80% of the drug releases within 30 minutes (critical for rapid onset).

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Chiral Purity: Clopidogrel has a chiral center. We strictly monitor to ensure the biologically active (S)-enantiomer is present and the inactive (R)-enantiomer is minimized.

5. Why Use Clopidogrel?

Keeps the blood flowing through stents and arteries.

• Mechanism: Clopidogrel is a prodrug. Once metabolized by the liver, its active metabolite irreversibly binds to the P2Y12 component of ADP receptors on the platelet surface. This prevents platelets from sticking together (aggregation), effectively stopping blood clots from forming inside stents or hardened arteries.

• Key Indications:

  • Acute Coronary Syndrome (ACS): For patients with unstable angina or heart attacks (STEMI/NSTEMI).

  • Post-Stent (PCI): Prevents the stent from getting blocked by a clot.

  • Ischemic Stroke: Prevents recurrent strokes.

  • Peripheral Artery Disease (PAD): Improves blood flow in legs.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers (with Bioequivalence Studies) 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 Tablets?

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

• Q: Is it Plavix?

  A: Plavix is the brand name (Sanofi/BMS). We manufacture the Generic Equivalent (Clopidogrel Bisulfate Form II).

• Q: Can I take it with acidity medicine?

  A: Caution required. Some acid reducers like Omeprazole and Esomeprazole block the liver enzyme (CYP2C19) needed to activate Clopidogrel, making it less effective. Pantoprazole is generally considered safer.

• Q: How long must I take it after a stent?

  A: Strictly follow your cardiologist. Stopping early can cause the stent to close (thrombosis), which is fatal. Usually, it is taken for 12 months post-stent.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• ACS / Heart Attack: Loading dose of 300mg (or 600mg), then 75mg once daily.

• Recent Stroke / PAD: 75mg once daily.

• Administration: Can be taken with or without food.

9. Side Effects and Precautions

• Bleeding: Increased risk of bruising, nosebleeds, and prolonged bleeding from cuts. Major Bleeding (GI bleed, intracranial) is the most serious risk.

• Surgery: Must be stopped 5 to 7 days before any elective surgery (including dental) to prevent excessive bleeding.

• Genetics: “Poor Metabolizers” (patients with CYP2C19*2 or *3 variants) may not respond well to Clopidogrel.

• Interaction: Avoid NSAIDs (Ibuprofen, Naproxen) as they increase bleeding risk.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from moisture. Keep in the original blister.