Levofloxacin Tablets

Description

Levofloxacin Tablets

Levofloxacin Tablets USP / BP / IP (250 mg / 500 mg / 750 mg)

Broad-Spectrum Third-Generation Fluoroquinolone Bactericidal Antibiotic

Healthy Life Pharma Private Limited, alongside our specialized global export and marketing division Healthy Inc, is a premier Indian manufacturer, CDMO services provider, and wholesale exporter of advanced anti-infectives, antimicrobials, and intensive public health therapeutics. We manufacture ultra-high-purity, kinetically stable Levofloxacin Tablets within our state-of-the-art, WHO–GMP certified solid dosage manufacturing installations.

Serving as a critical clinical asset for the eradication of complex bacterial infections, this broad-spectrum antimicrobial represents a high-velocity strategic export for national health ministry tenders, public hospital emergency reserves, institutional purchasing cooperatives, and international digital B2B marketplaces across the CIS region, Sub-Saharan Africa, LATAM, and South-East Asia.

Product Overview

This formulation operates as a “Bacterial DNA Replication Arrestor.” It ensures complete pathogen eradication and rapid clinical resolution by physically deactivating the specialized enzymes that bacteria require to replicate and repair their genetic material, inducing rapid cellular death.

• Mechanism 1 (Dual Enzyme Target Inhibition): Levofloxacin is the optically active L-isomer of ofloxacin. It physically penetrates the bacterial cell wall and chemically inhibits two critical target enzymes: Bacterial DNA Gyrase (Topoisomerase II) and Topoisomerase IV.

• Mechanism 2 (DNA Replication Mechanical Arrest): DNA Gyrase is responsible for relieving the structural torsional strain generated ahead of the moving replication fork. By physically blocking this enzyme, Levofloxacin halts the uncoiling, replication, and transcription of bacterial DNA.

• Mechanism 3 (Bactericidal Cellular Fragmentation): Concurrently, the inhibition of Topoisomerase IV chemically prevents the physical separation of replicated daughter chromosomes during cell division. This dual-action blockade fractures the bacterial chromosome structure, completely arresting bacterial reproduction and triggering rapid, concentration-dependent bactericidal cell death.

Product Composition & Available Portfolio

We manufacture Levofloxacin across the complete, internationally standardized therapeutic spectrum to accommodate customized tissue-saturation requirements and specific treatment durations.

Technical & Logistics Specifications

• HS Code: 3004.20.42 (Medicaments containing fluoroquinolones / Quinolone antibiotics) or 3004.20.99 (General Antibiotics Category)

• CAS Number: 100986-85-4 (Levofloxacin Anhydrous) / 138199-71-0 (Levofloxacin Monohydrate)

• Dosage Form: Oral Solid Film-Coated Tablet (Precisely coated to mask the intense bitter taste of the active quinolone core and shield it from ambient oxidation)

• Packaging Configurations:

  • Standard Blisters: 5 / 7 / 10 Tablets per Blister Strip packed in high-barrier Alu-Alu (Cold-Form Foil) or thick PVC/PVDC strips (optimized for the standard 5-to-10 day short-course antimicrobial cycle).

  • Institutional Tenders: Bulk packs of 100 / 500 Tablets per induction-sealed HDPE Bottle to maximize shipping cube efficiency and minimize baseline unit freight costs for national ministries. Our tropicalized packaging completely isolates the active core matrix, guaranteeing a stable 36-month shelf life in hot, humid Zone IVb export environments.

Advanced Quinolone Compression Technology & Quality Controls

               [ MICRONIZED LEVOFLOXACIN ACTIVE API ]
                                 │
                                 ▼
           [ HIGH-SHEAR WET GRANULATION BLENDING SUITE ]
                                 │ (Relative humidity held strictly below 40%)
                                 ▼
            [ ROTARY COMPRESSION WITH AUTOMATED FEEDERS ]
                                 │ (Radial hardness calibrated to 6.0-9.0 kp)
                                 ▼
            [ HYDROXYPROPYL METHYLCELLULOSE (HPMC) COATING ]
                                 │ (Complete chemical taste-masking barrier)
                                 ▼
           [ FLAWLESS NATIONWIDE BIOEQUIVALENCE SYNC ]

• High-Density Compact Granulation Processing: Levofloxacin active raw powder possesses an intensely bitter taste, a high dose mass, and naturally poor flow properties that can cause tablet capping or chipping. We deploy Advanced High-Shear Granulators and Fluid Bed Dryers, densifying the powder matrix into homogeneous granules. This eliminates density variations and ensures perfect weight uniformity during high-speed compression runs.

• Taste-Masking Barrier Film Coating: To prevent localized mucosal irritation and patient aversion, our processing lines apply a specialized HPMC-based Film Coat Barrier. This completely seals the core taste profile without altering gastrointestinal disintegration or dissolution speeds.

• Validated Release and Dissolution Kinetics: Every single production batch physically undergoes Automated Multi-pH In-Vitro Dissolution Profiling, chemically validating that our generic solid doses achieve immediate disintegration (under 10 minutes), ensuring rapid systemic absorption and precise bioequivalence to match global innovator references (such as Levaquin).

Primary Indications

• Pulmonology & Respiratory Care: First-line management of Community-Acquired Pneumonia (CAP), Nosocomial (hospital-acquired) Pneumonia, and acute bacterial exacerbations of chronic bronchitis.

• Urology & Nephrology: Treatment of complicated and uncomplicated Urinary Tract Infections (UTIs), acute pyelonephritis (kidney infection), and chronic bacterial prostatitis.

• Dermatology & Surgery: Management of complicated and uncomplicated Skin and Skin Structure Infections (including abscesses, cellulitis, and furuncles).

Usage Instructions

• The 24-Hour Administration Window: Take the tablet orally once daily at approximately the same time each day with a full glass of water. It can be administered consistently either with or without food.

• The Metal Chelation Dosing Rule: Advise clinical and retail distribution networks that Levofloxacin must be taken at least 2 hours before or 2 hours after ingesting antacids containing magnesium or aluminum, iron supplements, multivitamins containing zinc, or sucralfate. Co-administration allows divalent or trivalent cations to chemically chelate with the quinolone ring structure, physically blocking antibiotic absorption and causing immediate therapeutic failure.

• Hydration Reinforcement Requirement: Patients must maintain robust physical fluid intake throughout active management to ensure optimal renal clearance of the drug and completely prevent the rare risk of crystalluria.

Safety Warning: POTENT BROAD-SPECTRUM FLUOROQUINOLONE ANTIBIOTIC. For Professional Medical and Specialist Supervision Only. The Boxed Warning Matrix: Fluoroquinolones are chemically associated with an increased physical risk of Tendonitis and Tendon Rupture (especially the Achilles tendon), peripheral neuropathy, and central nervous system effects (anxiety, tremors, confusion). Discontinue therapy immediately if a patient experiences sudden tendon pain, inflammation, or neurological burning sensations. Aortic Aneurysm Caution: Use with extreme caution in elderly patients presenting with pre-existing cardiovascular risk profiles due to an increased risk of aortic aneurysm rupture. Contraindications: Absolute contraindications in patients with a documented history of tendon disorders related to fluoroquinolone administration, epilepsy/seizure disorders, pregnancy, lactation, or known hypersensitivity to quinolone derivatives.

Global CDMO Services & Wholesale Tender Supply

Healthy Life Pharma Private Limited and Healthy Inc provide complete, internationally validated Third-Party Contract Manufacturing (CDMO Services) and bulk private-label export supply for the entire Levofloxacin dosage spectrum. Because this molecule faces zero controlled-substance dual-licensing hurdles, our high-capacity lines can rapidly manufacture, release, and ship multi-container shipping loads. We deliver all required compliance documentation (WHO-GMP Certificate, Certificates of Pharmaceutical Product – COPP, Certificates of Analysis – COA, Zone IVb Stability Reports, and Complete CTD Format Dossier sets) for rapid entry registration.

Commercial & Bulk Procurement Inquiries:

• Corporate Head Office: Mumbai, Maharashtra, India

• Primary Manufacturing Base: Boisar, Maharashtra, India

• WhatsApp / Direct Call: +91 7710003340

• Corporate Email: info@healthyinc.co.in