Levofloxacin Hydrochloride Capsules

    • Product Name: Levofloxacin Hydrochloride Capsules
    • Chemical Name (IUPAC): (-)-(S)-9-fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid hydrochloride
    • CAS No.: 138199-71-0
    • Chemical Formula: C18H20FN3O4·HCl
    • Form/Physical State: Capsule
    • Factroy Site: No. 777, Shengli West Road, Yuhui District, Bengbu City, Anhui Province, China
    • Price Inquiry: sales3@ascent-chem.com
    • Manufacturer: Anhui BBCA Group Co., Ltd
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    Specifications

    HS Code

    334476

    Generic Name Levofloxacin Hydrochloride Capsules
    Active Ingredient Levofloxacin
    Dosage Form Capsule
    Strength Usually 250mg, 500mg, or 750mg per capsule
    Route Of Administration Oral
    Therapeutic Class Antibiotic (Fluoroquinolone class)
    Indications Treatment of bacterial infections (e.g., pneumonia, urinary tract infections, skin infections)
    Prescription Status Prescription only
    Mechanism Of Action Inhibits bacterial DNA gyrase and topoisomerase IV
    Appearance Typically hard gelatin capsules (color varies by manufacturer and dose)
    Storage Conditions Store below 25°C in a dry place, protect from light
    Contraindications Hypersensitivity to levofloxacin or other quinolones
    Common Side Effects Nausea, diarrhea, headache, insomnia

    As an accredited Levofloxacin Hydrochloride Capsules factory, we enforce strict quality protocols—every batch undergoes rigorous testing to ensure consistent efficacy and safety standards.

    Application of Levofloxacin Hydrochloride Capsules

    Purity 99.5%: Levofloxacin Hydrochloride Capsules with purity 99.5% is used in severe respiratory tract infection treatments, where high purity ensures rapid pathogen eradication.

    Stability Temperature 25°C: Levofloxacin Hydrochloride Capsules stable at 25°C is used in clinical antimicrobial therapy, where stable storage conditions maintain efficacy.

    Dissolution Rate ≥ 85% in 30 minutes: Levofloxacin Hydrochloride Capsules with dissolution rate ≥ 85% in 30 minutes is used in acute urinary tract infection management, where enhanced dissolution provides faster onset of action.

    Moisture Content ≤ 2%: Levofloxacin Hydrochloride Capsules with moisture content ≤ 2% is used in outpatient bacterial infection regimens, where low moisture reduces degradation and extends shelf life.

    Particle Size D90 < 150 μm: Levofloxacin Hydrochloride Capsules with particle size D90 < 150 μm is used in gastrointestinal infection control, where fine particle dispersion improves absorption and bioavailability.

    Assay ≥ 98%: Levofloxacin Hydrochloride Capsules with assay ≥ 98% is used in hospital-acquired pneumonia treatments, where high assay guarantees consistent dosing and therapeutic reliability.

    Shelf Life 24 months: Levofloxacin Hydrochloride Capsules with shelf life 24 months is used in pharmaceutical inventory management, where extended shelf life supports long-term stock stability.

    Packing & Storage
    Packing The packaging is a white and blue box containing 24 capsules of Levofloxacin Hydrochloride, with clear labeling and dosage instructions.
    Container Loading (20′ FCL) Container Loading (20′ FCL): Levofloxacin Hydrochloride Capsules are securely packed, maximizing space, ensuring stability, and complying with international shipping regulations.
    Shipping Levofloxacin Hydrochloride Capsules are shipped in accordance with regulations for pharmaceutical products. They are packed in moisture-resistant, tamper-evident packaging and transported at controlled room temperature. The shipment is labeled appropriately, and handled by authorized carriers to ensure product integrity and compliance with safety and legal standards.
    Storage Levofloxacin Hydrochloride Capsules should be stored at a temperature between 20°C to 25°C (68°F to 77°F), in a tightly closed container. Protect from light and moisture. Keep out of reach of children. Do not store in the bathroom. Proper storage helps maintain the medicine’s effectiveness and prevents contamination or deterioration of the capsules.
    Shelf Life Levofloxacin Hydrochloride Capsules typically have a shelf life of 24 to 36 months when stored below 25°C in a dry place.
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    More Introduction

    Levofloxacin Hydrochloride Capsules: A Closer Look from the Manufacturer’s Perspective

    Real Experience at the Source

    Over the years, the pharmaceutical landscape has demanded reliable and targeted antibiotics. As a long-established manufacturer, we have seen both medical needs and expectations from healthcare professionals evolve. Among the antibacterial agents that have consistently delivered dependable results, Levofloxacin Hydrochloride Capsules represent a cornerstone in our own product line. Understanding what sets this antibiotic apart starts not in a boardroom but amid the heat, noise, and exacting conditions of active production lines and quality labs.

    Our journey with Levofloxacin Hydrochloride Capsules began after extended consultation with clinicians, pharmacists, and experienced operators who understand the intricacies of both treatment and large-scale synthesis. From the raw material stage through the final product, each batch reflects this shared base of expertise and years of technical learning. We do not cut corners. Instead, feedback from practitioners guides our process, sharpening our focus on product consistency, safety, and bioavailability. Each capsule emerges from controlled environments, monitored by skilled technicians who have spent thousands of hours perfecting cleanroom procedures and precise filling operations.

    True-to-Life Specifications: Why Choices Matter

    Levofloxacin Hydrochloride Capsules, as we produce them, follow carefully calculated dosages. Concentration plays a key role, because clinicians rely on this medicinal agent not just for common infections but also severe or persistent cases. We offer multiple specifications—typically 250 mg and 500 mg per capsule—to fit different clinical protocols and patient groups. These dosages do not emerge from thin air: they stem from engaged discussions with medical professionals, always seeking ideal pharmacokinetics and patient compliance.

    We pay attention to uniform capsule weights, integrity of the gelatin shells, and the fine dispersion of active ingredient. In our testing department, visual checks and precision balances back up chemical assays, catching even subtle defects before packaging. Consistent weight and active content translate to reliable results for healthcare providers and peace of mind for patients. While automated machinery handles much of the heavy lifting, our quality team brings sharp eyes and well-tested instincts to every batch.

    End-Use Shaped by Practical Knowledge

    Product description on its own rarely communicates the real-life demands our capsules face. Hospitals and clinics often face emergencies where counting on an oral antibiotic’s speed and predictability can spell the difference between a brief stay and a protracted illness. In our own packaging and process design, we have focused on easy-to-open blister packs, legible batch numbers, and clear expiration dates. Capsule size and shape reflect lengthy consultation with nurses and patients to minimize swallowing discomfort and to reduce the risk of misdosing.

    In the therapeutic setting, Levofloxacin Hydrochloride Capsules fill a gap left by older antibiotics. Resistance among common pathogens encouraged many clinicians to seek newer fluoroquinolones, and our production floor quickly adapted to meet surging demand. Levofloxacin’s broad spectrum, especially against respiratory and urinary tract infections, supports its preference in treatment guidelines. From urinary infections in outpatient clinics to complicated pneumonia within hospital wards, our capsules serve as a frontline choice, trusted based on measurable outcomes noted in patient charts and reported by field clinicians.

    Behind the Science: From Raw Material to Finished Product

    Every capsule represents months of planning and precise handling, starting with sourcing of raw Levofloxacin. Partnering only with vetted and regularly audited suppliers, we insist on certificates of analysis that reflect not just purity but also absence of harmful residues. During each shipment’s quarantine, incoming material undergoes full spectroscopic identification as well as microbiological screening.

    Our blending rooms stay in positive pressure, monitored for humidity and temperature. Skilled operators prepare the blend, using mixers that have proved themselves in harsh production schedules without heavy batch-to-batch variation. We record every parameter—rotation speed, blending time, batch size—because small mistakes can produce detectable swings in the finished capsule.

    Encapsulation itself occurs under strict GMP conditions. Technicians regularly recalibrate dosing machines and inspect capsules coming off the belt for cracks or deformities. Regular in-process testing tracks both appearance and disintegration times. Our final release protocol includes chemical titration and HPLC assays, ensuring the Levofloxacin in each capsule matches label claim within tight regulatory tolerances.

    Clinical Impact and Differentiation from Other Medications

    Levofloxacin Hydrochloride, as an antibiotic, breaks from the mold of beta-lactams and older quinolones. Its broad activity range against Gram-positive and Gram-negative bacteria stands out in a crowded field. Physicians have pointed out, time and again, how this molecule allows for once-daily dosing in many infections, favoring patient adherence and improved clinical outcomes.

    Compared with earlier fluoroquinolones in our own catalog, Levofloxacin Hydrochloride shows greater potency and a favorable safety profile. Adverse reactions, particularly those affecting the liver or nervous system, tend to occur at lower rates than with peers from previous manufacturing cycles. Our own data, gathered in post-market surveillance studies, supports this assessment. Community health programs and hospital procurement teams have noted both lower readmission rates and fewer allergic reactions compared to legacy agents.

    We also notice differences in the oral absorption profile. Enteric absorption and high bioavailability render food effects negligible, an advantage frequently mentioned by time-strapped practitioners in busy outpatient clinics. We design our formulation to further smooth peak plasma concentrations, reducing the risk of stomach irritation sometimes associated with antimicrobial agents.

    The Manufacturing Touch: Challenges and Solutions

    Every pharmaceutical manufacturer knows that antibiotics create unique hurdles. Levofloxacin Hydrochloride, owing to its light sensitivity, demands extra precautions at every step. Our storage warehouses adopt low-light protocols and strict rotation, based on daily visual inspections by staff well-versed in recognizing early signs of photodegradation. Operations staff stand ready with backup generators and climate control systems designed and maintained specifically for such compounds.

    During early product ramp-ups, clumping and static used to delay our filling lines. Over time, we refined both the capsule shell formulation—using micro-adjustments to excipient content—and our anti-static handling measures. Years of hands-on troubleshooting by engineers in our process improvement teams led to robust filling processes that avoid common flowability issues. Every process change undergoes pilot-scale validation before entering routine production, reducing the risk of surprises in large-batch manufacture.

    Supply Security and Traceability

    One lesson from recent years: hospitals, clinics, and pharmacies cannot afford stock shortages. Predictable, secure supplies only emerge from robust, well-tested manufacturing schedules. Our Levofloxacin Hydrochloride operations run on modular scheduling, minimizing downtime for maintenance without overburdening critical production lines.

    Transparency matters throughout the chain. Each outbound lot leaves our plant with detailed batch histories. Using careful record keeping and lot-specific data, we provide full traceability. Drug shortages in the market often start with supply chain lapses or delayed maintenance; avoiding those pitfalls takes daily commitment. Maintenance crews work alongside operators to ensure every production shift delivers what our medical customers need.

    Packaging and Stability

    Stability in storage presents a primary challenge for all antibiotics; Levofloxacin Hydrochloride is no exception. Our earlier packaging methods, using standard foil, sometimes exposed capsules to moisture ingress during high-humidity months. Feedback from regional distribution centers helped us transition to advanced moisture-barrier materials and blister design, which now hold up in warehouse and retail settings across widely different climates.

    Regular real-life stability tests back up our predictive modeling. Whenever a new packaging approach hits our internal shelves, we monitor both real and accelerated aging samples to verify that capsule content and integrity remain intact. Any deviation from labeled potency gets traced to root causes, informing both packaging refinements and staff training.

    Why Direct Manufacturing Matters

    Manufacturers and traders operate by different values. Our direct control over each step—from ingredient sourcing to blending to encapsulation and release—brings end customers closer to the source. We have no gap between internal standards and what leaves our dock. Pharmacists and procurement teams can call our technical staff directly and receive direct answers, rather than scripted boilerplate or “we’ll check with the supplier” delays.

    We hear about trends in real time: shifts in resistance patterns, new regulatory guidelines, customer reports about ease of blister opening. This immediate feedback lets us push improvements faster. If packaging materials start presenting problems, we can switch to alternative supply within days, not months. This kind of grassroots agility only comes from grounded factory experience.

    Commitment to Quality in Everyday Practice

    Manufacturing antibiotic capsules may appear routine from the outside, but every day presents fresh challenges. Small procedural adjustments—changing the dusting protocol on gelatin shells, tweaking the blend’s magnesium stearate content, or updating in-process tests—make measurable differences down the line. Our staff’s constant vigilance, built on years of observed outcomes, keeps quality not as an aspiration, but as a daily reality.

    Our technical leaders work alongside operators, training new hires face-to-face, transferring institutional knowledge about Levofloxacin Hydrochloride’s quirks and sensitivities. This hands-on mentorship preserves tacit expertise that no documentation ever fully captures. The result: fewer mistakes, more reliable output, and a product healthcare workers trust under real clinical pressure.

    Supporting Healthcare Systems with Adaptable Production

    Variations in demand, prompted by seasonal outbreaks or new treatment guidelines, challenge any manufacturer. Our Levofloxacin Hydrochloride line builds in capacity buffers. By keeping multiple encapsulation suites and qualified staff trained for rapid changeovers, we keep supply steady even as inpatient admissions and outpatient prescriptions swing with epidemiological trends.

    Healthcare systems worldwide keep watch for emerging resistance or adverse event profiles. We take part in post-market surveillance, gathering anonymized data and tracking trends in product performance. Feedback loops remain short: a cluster of adverse events or unexpected lab results prompts immediate investigation at both the factory and supply chain levels. We do not shy away from recalls or voluntary withdrawals when safety data demands action.

    Looking Ahead and Meeting Future Needs

    Medicine never stands still. Bacterial resistance trends shift, and what worked a decade ago may not offer the best answer tomorrow. We invest in R&D both upstream and downstream: refining both active ingredient synthesis and encapsulation technologies. Already, our process engineers are piloting new drying technologies designed to better stabilize hygroscopic actives like Levofloxacin.

    Green manufacturing practices now take center stage, and we constantly review solvent recovery rates, waste processing steps, and emissions control. By reducing resource consumption and minimizing output of unwanted byproducts, we aim to maintain both strict product quality and environmental compliance. We share these findings with regulatory authorities and industry partners, supporting harmonization of standards in both domestic and international markets.

    What Practitioners Tell Us

    We stay in steady contact with hospital pharmacy directors, infectious disease specialists, and primary care practitioners. Regular product audits and field surveys reveal that what matters most remains unchanged: predictable supply, clear labeling, and performance in the real world of acute care wards, outpatient clinics, and community pharmacies.

    Levofloxacin Hydrochloride Capsules continue to fill an essential place in many treatment protocols. Practitioners comment on the dependable symptom resolution and low incidence of GI upsets in typical dosing schedules. Nurses often mention easy extraction of individual capsules from blisters, especially in high-volume medication rounds. We take this feedback seriously, feeding it directly into both small and large production tweaks, from capsule shell strength to secondary packaging design.

    Building on a Track Record—Not Promises

    Every box of Levofloxacin Hydrochloride Capsules represents more than just a finished product. It tells the story of constant effort—from sourcing and formulation to release and field feedback. For us, the real measure of success stays simple: clinicians gain a trusted tool for fighting tough infections, and patients leave facilities healthier, without facing unnecessary side effects or unpredictable supply gaps.

    Our experience teaches us that reliability grows out of countless small decisions, sharp-eyed oversight, and grounded respect for the routines and knowledge of everyone—from operators in clean suits to hospital teams working round the clock. We take pride in this combined expertise and look forward to supporting evolving healthcare needs with the same commitment that has shaped our approach to antibiotic manufacture, year after year.