HK Neopharm Limited is one of the most reliable manufacturers and suppliers of sitafloxacin tablets in China, featured by quality products and good price. Please rest assured to buy sitafloxacin tablets in stock here and get quotation from our factory. Customized orders are welcome.
Sitafloxacin Tablets is a new-generation fluoroquinolone oral antibacterial agent. By inhibiting bacterial DNA gyrase and topoisomerase IV, it blocks bacterial nucleic acid replication and transcription to achieve broad-spectrum and potent bactericidal effect. It has high antibacterial activity against Gram-positive bacteria, Gram-negative bacteria, anaerobes, as well as atypical pathogens such as mycoplasma and chlamydia. In particular, it still maintains good activity against some drug-resistant strains, making it an important choice for the clinical treatment of multi-system bacterial infections.
Technical Specifications
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Product Name |
Sitafloxacin Tablets |
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Synonyms |
Sitafloxacin Oral Tablets,Sitafloxacin Antibiotic Tablets |
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Characteristics |
white to pale yellow film‑coated tablet |
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CAS Number |
127254-12-0 |
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Assay |
≥99.0% (HPLC, Subject to the COA) |
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Formula |
C19H18ClF2N3O3 |
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Package |
Technical Package |
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Storage |
Keep tightly closed, store in a cool and dry place, protect from light and moisture |
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Structure |
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Relying on a mature formulation process and a full-process quality control system, Sitafloxacin Tablets undergo strict quality testing, featuring uniform content, controllable impurities, as well as excellent stability and batch consistency. As a core oral quinolone antibacterial preparation in the clinical anti-infective field, it can meet the needs of prescription medication, clinical research and large-scale production and supply, providing high-quality finished product support for therapeutic drugs for bacterial infectious diseases.
Product Features
Sitafloxacin Tablets is a new-generation broad-spectrum quinolone antibacterial agent, a core oral preparation for clinical bacterial infection treatment, which can fully cover the treatment needs of multi-site infections including respiratory tract, urinary tract, reproductive tract, oral and maxillofacial infections.
This product is manufactured in strict accordance with international GMP standards, with refined quality control implemented throughout the entire process. It features qualified content uniformity, strict control of related substances, and stable dissolution, with all key quality indicators meeting pharmacopoeia requirements and excellent batch consistency, providing reliable quality support for formulation consistency evaluation, registration and declaration, as well as large-scale production.
As a potent Sitafloxacin Tablet Drug, this product can accurately inhibit bacterial DNA gyrase and topoisomerase IV, with a broad antibacterial spectrum and strong bactericidal power. It also has good activity against multi-drug resistant strains. Sitafloxacin 50mg Tablets has a scientific dosage design, with good oral absorption and wide in vivo distribution, balancing efficacy and safety, and can meet the diversified anti-infective treatment needs of outpatient and inpatient patients.
We provide complete COA, HPLC spectra, MSDS and registration support documents, supporting standard warehousing and moisture-proof and light-proof transportation conditions to fully ensure product stability. Sitafloxacin Tablets series specifications have sufficient stock, which can quickly respond to the full-process supply needs of global pharmaceutical companies for R&D, pilot test and commercial production.
Full-Cycle Quality Control & Consistent Quality
Quality is the core competitiveness of Sitafloxacin Tablets. We have established a full-process quality control system from the incoming of raw materials and excipients to the outbound of finished products, supporting the R&D, clinical research and registration and declaration of anti-infective drugs with stable and reliable quality.
Parameterized closed-loop monitoring is implemented for key processes such as granulation, tableting and coating, to accurately control content uniformity, dissolution and related substances, ensuring the stable quality of intermediate products from the source. The finished products undergo multi-stage screening and standardized molding process to ensure the consistency of physical and chemical properties and drug efficacy, fully complying with pharmacopoeia and ICH guidelines.
Each batch of Sitafloxacin 50mg Tablets is provided with a complete COA report, covering all indicators such as characteristics, identification, assay, dissolution, microbial limit, etc. The test data is fully traceable with small batch-to-batch variation, meeting the strict standards for R&D, pilot test and declaration.
Through accelerated tests, long-term sample retention, and investigation of influencing factors such as light, temperature and humidity, we have fully verified the stability of the product under the storage and transportation conditions of cool and dry place, sealed and protected from light, effectively controlling degradation and impurity growth, ensuring that all indicators of the product remain stable and reliable within the validity period.
Application Scenarios
As a new-generation broad-spectrum oral quinolone antibacterial preparation, Sitafloxacin Tablets has a broad antibacterial spectrum and strong clinical applicability. It is a core preparation for the treatment of adult bacterial infections, which can cover the drug development and clinical medication needs of multi-system infections such as respiratory, urinary, reproductive, oral and maxillofacial infections. The specific scenarios are as follows:
Sitafloxacin Oral Tablets is one of the first-choice therapeutic preparations for respiratory tract infections such as community-acquired pneumonia, acute bronchitis, pharyngitis, tonsillitis, otitis media and sinusitis. It has strong antibacterial effect and quick onset, and can meet the needs of standardized anti-infective treatment for outpatient and home-based patients.
This product is suitable for urinary tract infections such as cystitis, pyelonephritis, urethritis and prostatitis, and is highly sensitive to common urinary pathogenic bacteria. Sitafloxacin 50mg Tablets has accurate dosage and convenient administration, and can be used for the whole-course treatment of both uncomplicated and complicated urinary tract infections.
Sitafloxacin Antibiotic Tablets can be used for sensitive bacterial infections of the reproductive system such as cervicitis and pelvic inflammatory disease, as well as oral and maxillofacial infections such as periodontitis and pericoronitis, balancing the treatment of deep and superficial infections, providing stable support for clinical medication in multiple departments.
As a mature Sitafloxacin Tablet Drug, this product is widely used in common bacterial infectious diseases such as skin and soft tissue infections and wound infections. It also supports generic drug development, consistency evaluation, prescription process optimization and registration and declaration, providing comprehensive and reliable preparation support for commercial production and clinical research of anti-infective drugs.
Packaging and Transportation
Combined with the characteristics of Sitafloxacin Tablets that it is susceptible to light, humidity and temperature fluctuations, which may lead to impurity growth and property changes, we have customized a full-process packaging and transportation protection plan to fully ensure the quality stability of the product from delivery to handover. The specific implementation is as follows:
Precise Temperature and Humidity Control and Traceability
For the characteristics of Sitafloxacin Antibiotic Tablets that it is hygroscopic and sensitive to temperature fluctuations, we adopt a constant temperature cool transportation solution throughout the process, equipped with real-time temperature and humidity monitoring equipment with automatic alarm for over-temperature and over-humidity. The data is recorded throughout the process and a temperature control report is attached with the goods. We strictly control the storage and transportation temperature at ≤20℃ and relative humidity at ≤75%, preventing the influence of temperature and humidity fluctuations on product content and stability.
Light Protection and Enhanced Packaging Protection
Combined with the photosensitive characteristics of the product, the inner packaging adopts moisture-proof and light-proof aluminum-plastic blister, and the outer packaging adopts double-layer light-proof aluminum foil bag + moisture-proof rigid turnover box, with built-in food-grade desiccant to doubly isolate light and moisture. The packaging is clearly marked with warning signs of "Keep away from light, keep dry, store in a cool place", avoiding product degradation caused by light and moisture absorption during transportation and storage, ensuring the perfect quality of Sitafloxacin 50mg Tablets.
Standardized Warehousing and Expiry Date Management
The warehousing environment strictly follows GMP requirements, with a special cool constant temperature and humidity warehouse, partitioned storage and special person management, and strictly implements the First-In-First-Out (FIFO) principle. We regularly conduct stability sampling inspection on the inventory Sitafloxacin Oral Tablets, establish an expiry date early warning mechanism, and remind customers of the stocking cycle in advance to avoid the impact of expired validity period on use, perfectly adapting to the needs of R&D, pilot test and commercial production.
Transportation Compliance and Carrier Control
We select carriers with GSP certification and professional drug transportation qualifications, and audit their calibration records of transportation equipment and professional qualifications of personnel. For international transportation, we adapt to the drug regulatory regulations of the destination country in advance, improve customs declaration, quarantine and relevant compliance documents for drug transportation, avoid the risk of goods detention, and ensure the global compliant delivery of Sitafloxacin Tablet Drug.
Full-chain Traceability and Emergency Disposal
We have established a full-chain traceability system from production, warehousing, transportation to delivery, and each batch of products can be traced back to the whole process of raw material incoming, production process and finished product testing. We formulate an emergency plan for abnormal transportation and warehousing, and can respond quickly to unexpected situations such as packaging damage and temperature and humidity exceeding the standard, replace the product in time and complete quality re-inspection simultaneously, minimizing the customer's use risk.
Our Advantages
Mature Process and Serial Supporting
We have a mature and stable formulation process for Sitafloxacin Tablets, with closed-loop control of parameters in the whole processes of granulation, tableting and coating, ensuring excellent dissolution consistency and bioavailability. At the same time, we can provide customized specifications and customized packaging services, one-stop to meet customers' multi-scenario procurement needs from R&D pilot test to commercial production.
Strict Quality Control, Compliant and Reliable
Sitafloxacin Antibiotic Tablets is manufactured in strict accordance with international GMP standards, with fully traceable quality throughout the process. Key indicators such as content uniformity, dissolution and related substances all meet the requirements of mainstream pharmacopoeia such as USP, EP and CP, providing complete and reliable data support for formulation consistency evaluation and registration and declaration.
Large-scale Supply and Stable Delivery Time
We have large-scale production capacity for Sitafloxacin Tablets 50mg, with sufficient spot inventory and stable delivery time. We can quickly respond to different needs of small-scale R&D orders, pilot test verification and large commercial orders, ensuring the stable supply of Sitafloxacin 50mg Tablets in all stages.
Technical Service and High Cost Performance
We provide complete technical support and full set of compliance documents such as COA and HPLC spectra, and can cooperate with customers to complete the whole process of prescription process optimization, consistency evaluation, registration and declaration. With professional services and high cost performance advantages, we have become the preferred partner in the field of Sitafloxacin Oral Tablets and Sitafloxacin Tablet Drug.
FAQ
If you have understood the relevant preparations in the anti-infective field, the high-quality Sitafloxacin 50mg Tablets oral antibacterial drug and professional supporting services, and are interested in this, welcome to negotiate with us at any time. We can provide accurate and real-time product quotation, one-to-one technical support, as well as customized cooperation solutions from R&D pilot test, pilot verification to commercial supply, providing stable and reliable preparation support for the progress of your bacterial infection treatment drug project.
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