Description

Prasugrel Film-Coated Tablets (5 mg / 10 mg)

Healthy Inc is a specialized global supplier and exporter of advanced cardiovascular, anti-thrombotic, and acute critical-care therapeutics. We provide ultra-high-purity, kinetically stabilized Prasugrel Hydrochloride Film-Coated Tablets (5 mg / 10 mg), manufactured in WHO–GMP certified, strictly humidity-controlled oral solid dosage facilities. This “Next-Generation Thienopyridine P2Y12 Inhibitor” is a highly lucrative, premium export to cardiac catheterization labs, specialized cardiology centers, intensive care units (ICUs), and government health ministries in LATAM, the CIS, Africa, and Southeast Asia, serving as the globally mandated, rapid-onset intervention for the prevention of stent thrombosis in Acute Coronary Syndrome (ACS).

Product Overview

This highly advanced formulation contains Prasugrel, a potent, third-generation antiplatelet prodrug that fundamentally outclasses older therapies by delivering a massive, instantaneous, and genetically independent blockade of platelet aggregation during cardiac emergencies.

The “Predictable P2Y12 & Stent Defender” Specialist:

• Mechanism 1 (The Irreversible Platelet Blockade): Once absorbed, Prasugrel is rapidly metabolized into its active form. It aggressively and irreversibly binds to the P2Y12 class of ADP receptors on the surface of blood platelets. By locking down this receptor for the entire lifespan of the platelet (7 to 10 days), it permanently strips the platelets of their ability to stick together and form deadly clots inside newly placed coronary stents.
• Mechanism 2 (The Clopidogrel-Resistance Solution – CRITICAL): Older drugs like Clopidogrel require a complex, multi-step metabolic activation in the liver heavily dependent on the CYP2C19 enzyme. Millions of patients globally carry a genetic mutation making this enzyme sluggish, leading to “Clopidogrel Resistance” and sudden heart attacks post-surgery. Prasugrel utilizes a totally different, highly efficient esterase-mediated activation pathway. It delivers profound, consistent blood-thinning regardless of the patient’s genetics.
• The “Rapid Cath Lab Onset” Advantage: Time is muscle during a heart attack. Prasugrel achieves peak platelet inhibition significantly faster and more potently than Clopidogrel, making it the supreme choice for interventional cardiologists preparing a patient for immediate Percutaneous Coronary Intervention (PCI).

Technical & Logistics Specifications

Critical data for Pharmaceutical Importers, Cardiology Distributors, and Hospital Procurement Boards.

Manufacturing Authority

Marketed and Distributed by Healthy Inc from WHO-GMP & ISO 9001:2015 certified units.

• Hydrolytic Degradation Control & Dry-Granulation Engineering: Formulating Prasugrel requires elite environmental control. The ester group on the molecule is highly susceptible to hydrolysis if exposed to water during manufacturing. Our facilities completely bypass traditional wet granulation, utilizing advanced dry-blending and roller compaction under strict, ultra-low humidity environmental suites (RH < 30%). This guarantees the prodrug remains 100% structurally intact from our presses to the patient’s bloodstream.

Therapeutic Indications (Human Use)

Indicated for the targeted management of severe thrombotic cardiovascular events (co-administered with Aspirin):

• Acute Coronary Syndrome (ACS) managed with PCI: Reduction of thrombotic cardiovascular events (including stent thrombosis) in patients with ACS who are to be managed with percutaneous coronary intervention (PCI) for unstable angina (UA), non-ST-segment elevation myocardial infarction (NSTEMI), or ST-segment elevation myocardial infarction (STEMI).

Dosage & Administration

Recommended Dosage (Strictly as per Interventional Cardiologist Guidelines):

• Acute Loading Dose: Initiate treatment as a single 60 mg oral loading dose in the hospital/cath lab setting.
• Maintenance Dose: Continue at 10 mg orally once daily. Patients weighing < 60 kg should receive a reduced maintenance dose of 5 mg once daily.
• Administration: Can be administered with or without food. The tablet must be swallowed whole to preserve the moisture-barrier film coating.
• Dual Antiplatelet Therapy (DAPT): Prasugrel MUST be taken in combination with Aspirin (75 mg to 325 mg daily) as directed by the cardiologist.

Safety Warnings (CRITICAL Regulatory & Clinical Data):

• BLACK BOX WARNING (Significant, Sometimes Fatal Bleeding): Prasugrel causes profound, irreversible platelet inhibition. It can cause significant, sometimes fatal, major bleeding (gastrointestinal or intracranial). It must not be used in patients with active pathological bleeding or a history of Transient Ischemic Attack (TIA) or stroke.
• BLACK BOX WARNING (CABG Surgery): In patients requiring Coronary Artery Bypass Graft (CABG) surgery, Prasugrel must be discontinued at least 7 days prior to the procedure to prevent catastrophic surgical hemorrhage.
• Elderly Patients (≥ 75 Years): Generally not recommended for use in patients ≥ 75 years of age due to an exceptionally high risk of fatal intracranial bleeding. If deemed absolutely necessary, a reduced maintenance dose of 5 mg must be used.
• Premature Discontinuation: Stopping Prasugrel prematurely (before the cardiologist-recommended 12 months post-stent) massively increases the risk of sudden stent thrombosis, myocardial infarction, and death.

Global Export & Contract Manufacturing Services

Healthy Inc stands as a premier Pharmaceutical Exporter in India, dedicated to serving the needs of international Pharma Traders, Wholesalers, and Cardiac Hospital Networks. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) services for Advanced Cardiovascular and Anti-thrombotic Formulations. Whether you are looking for a reliable Government Tender Supplier for cath labs in Africa or a B2B Pharma Marketplace partner for Latin America, our logistics network ensures timely, secure delivery of highly stable, WHO-GMP certified products.