Description

Cefuroxime Axetil Film-Coated Tablets (250 mg / 500 mg)

Healthy Inc is a specialized global supplier and exporter of advanced anti-infectives, respiratory medicine, and targeted cephalosporin therapeutics. We provide ultra-high-purity, kinetically optimized Cefuroxime Axetil Tablets (250 mg / 500 mg), manufactured in WHO–GMP certified, dedicated Beta-Lactam high-containment facilities. This “2nd-Generation Cephalosporin & Beta-Lactamase Stable Antibiotic” is a massive-volume, premium export to ENT clinics, pulmonary centers, and government health ministries, serving as the globally mandated intervention for severe Lower Respiratory Tract Infections (LRTI), Acute Otitis Media, and Lyme Disease.

Product Overview

This formulation operates as a structural executioner of pathogenic bacteria. It is an orally active prodrug that is rapidly hydrolyzed in the intestinal mucosa and blood to release Cefuroxime, a powerful agent that shatters the protective architecture of the bacterial cell.

 

  • Mechanism 1 (The Cell Wall Rupture): Cefuroxime binds with high affinity to Penicillin-Binding Proteins (PBPs) located on the inner membrane of the bacterial cell wall. This prevents the final transpeptidation step of peptidoglycan synthesis. Without a stable cell wall, osmotic pressure causes the bacteria to physically explode (Lysis).

     

  • Mechanism 2 (Resistance to Beta-Lactamases): Unlike older penicillins, Cefuroxime possesses high stability against many Beta-Lactamase enzymes produced by bacteria like H. influenzae and S. aureus. This makes it a devastatingly effective “Shield-Breaker” for infections that fail standard first-line therapy.

     

  • Mechanism 3 (The Axetil Prodrug Strategy): Cefuroxime itself is not absorbed in the gut. By esterifying it into the Axetil form, the molecule becomes lipophilic, allowing it to glide through the intestinal lining. Once inside, esterases unleash the active antibiotic payload.

     


Product Composition & Strength

We supply this product as a Precision-Blended, Amorphous Solid Dispersion Tablet, packed exclusively in secure, moisture-resistant Alu-Alu blister strips.

Active IngredientStrengthPrimary Clinical Function
Cefuroxime Axetil USP/Ph.Eur.250 mgThe Pediatric & ENT Anchor: Utilized for Acute Otitis Media, Pharyngitis, and uncomplicated UTIs.
Cefuroxime Axetil USP/Ph.Eur.500 mgThe Respiratory Macrodose: Utilized for Community-Acquired Pneumonia, Bronchitis, and early-stage Lyme Disease.
ExcipientsProprietary MatrixAmorphous Solid Dispersion Technology: Engineered to maintain the API in its highly-soluble amorphous state for maximum clinical cure rates.

Technical & Logistics Specifications

  • HS Code: 3004.20.00 (Medicaments containing antibiotics)

     

  • CAS Number: 64544-07-6 (Cefuroxime Axetil)

     

  • Dosage Form: Film-Coated Tablet (Immediate Release)

  • Packaging: Alu-Alu Blisters (STRICTLY MANDATORY). Cefuroxime Axetil is fiercely hygroscopic and will degrade if exposed to humidity. Alu-Alu is the only packaging that guarantees 24-month stability in Zone IVb tropical climates.


Manufacturing Authority & Compliance

  • Dedicated Beta-Lactam Containment: Cross-contamination with Beta-Lactams can trigger fatal anaphylaxis. Our facility utilizes Strictly Isolated Dedicated Lines with separate HVAC systems.

     

  • Moisture Control: We utilize Dehumidified Processing (RH < 30%) to protect the amorphous API from reverting to the less-soluble crystalline state.

Dosage & Administration

  • The “Full Stomach” Mandate: This tablet MUST be taken after food. Absorption is significantly enhanced in the presence of a meal. Taking this on an empty stomach results in therapeutic failure.

     

  • The No-Crush Warning: The film coating is essential to mask the intensely bitter taste. If crushed, the taste is intolerable and may lead to non-compliance or vomiting.

Safety Warning: Use with extreme caution in patients with a history of penicillin allergy (10% cross-reactivity risk). May cause C. Difficile-associated diarrhea. Avoid concurrent use with strong antacids or PPIs as they decrease absorption.


Global Export & Contract Manufacturing

Healthy Inc is a premier Pharmaceutical Exporter in India. As a verified Medicine Supplier in Mumbai, we offer flexible Third Party Manufacturing (Contract Manufacturing) for high-end Cephalosporins. Whether you are a Government Tender Supplier for respiratory health in Africa or a B2B Pharma Marketplace partner in Latin America, we ensure secure, WHO-GMP compliant delivery.

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