HK Neopharm Limited is one of the most reliable manufacturers and suppliers of sitafloxacin fda approval in China, featured by quality products and good price. Please rest assured to buy sitafloxacin fda approval in stock here and get quotation from our factory. Customized orders are welcome.
Sitafloxacin is a new-generation broad-spectrum fluoroquinolone antibacterial active pharmaceutical ingredient. With strong antibacterial activity, excellent safety and wide clinical applicability, it has become a core raw material in the anti-infective field. The official approval of Sitafloxacin with FDA clearance further establishes its authoritative position in the global antibacterial drug market and provides an effective solution for the treatment of multi-drug resistant bacterial infections. Sitafloxacin Raw Material is produced with advanced directional synthesis technology, featuring accurate structure and stable purity, which can fully meet the strict requirements of global pharmaceutical enterprises and research institutions in new drug development, preparation production and clinical application. Sitafloxacin API exerts a strong bactericidal effect on a variety of pathogenic bacteria and pathogens, maintaining high activity against common clinical drug-resistant strains, making it a key pharmaceutical raw material for the treatment of severe infections such as respiratory tract and genitourinary system infections.
Technical Specifications
|
Product Name |
Sitafloxacin fda approval |
|
Synonyms |
Sitafloxacin Powder, Sitafloxacin API, Sitafloxacin Raw Material |
|
Characteristics |
White to off-white crystalline powder |
|
CAS Number |
127254-12-0 |
|
Assay |
≥99.0% (HPLC, Subject to the COA) |
|
Formula |
C19H18ClF2N3O3 |
|
Package |
Technical Package |
|
Storage |
Store at -20°C |
|
Structure |
|
Product Features
Sitafloxacin API adopts new-generation synthesis and purification technology, breaking through the purity bottleneck of traditional quinolone drugs. Its major component content is stably above 99.0%, and the impurity level is far lower than the pharmacopoeia limit, fully complying with pharmaceutical-grade API standards and ensuring the safety and effectiveness of preparations from the source. The product has a broad antibacterial spectrum and strong bactericidal ability, causing potent inhibition on key clinical pathogens such as Staphylococcus aureus, Streptococcus pneumoniae, Escherichia coli, Klebsiella, Pseudomonas aeruginosa, as well as atypical pathogens such as Mycoplasma and Chlamydia.
It has a low cross-resistance rate with other antibacterial drugs and can be used as a first-line raw material for the treatment of multi-drug resistant bacterial infections. Sitafloxacin Powder has stable physical and chemical properties and low hygroscopicity . It is compatible with mainstream preparation processes such as dry granulation, wet granulation and sterile filling, effectively improving production efficiency and the stability of final products. As a highly active Sitafloxacin API, the product is rapidly absorbed in vivo with high bioavailability and wide tissue distribution. It reaches a high concentration in infected target organs with a long-lasting effect, quickly controlling infection symptoms and shortening the treatment cycle, making it a core raw material for high-end antibacterial preparations.
Full-Cycle Quality Control and Stable Quality
Whole-Process Traceability Control
The product follows a full-chain quality traceability system. With complete records and data retention for each link and a COA test report provided for each batch of Sitafloxacin Powder, we realizes full-process traceability, verification and validation from raw materials to finished products, ensuring the elimination of quality risks.
Strict Standard Compliance Guarantee
The product is manufactured in strict accordance with international standards such as ICH, Chinese Pharmacopoeia, United States Pharmacopoeia and European Pharmacopoeia. It undergoes comprehensive tests including HPLC assay, related substances, moisture, residue on ignition, heavy metals and microbial limit, ensuring that all indicators are superior to pharmacopoeia requirements. Impurities and microbial control are far below compliance limits, meeting global pharmaceutical-grade quality standards and supporting customers in successfully completing drug registration and declaration in various countries.
Continuous Quality System Optimization
The product chain engages continuous process optimization and equipment upgrading. The reduced production costs and the improvement of purity and stability together guarantee the long-term stable supply of Sitafloxacin API.
Application Scenarios
Antibacterial Preparations
Sitafloxacin API is the core raw material for the production of various antibacterial drugs such as oral tablets, capsules, injections, eye drops and topical preparations. With a wide range of clinical applications and stable market demand, it is widely used in the treatment of various bacterial infectious diseases including respiratory tract infections, urinary system infections, abdominal infections, skin and soft tissue infections, ear, nose and throat infections.
Drug-Resistant Bacterial Infection Treatment
High-quality Sitafloxacin Raw Material provided for research institutions and pharmaceutical enterprises supports the screening of new antibacterial drugs, dosage form optimization, pharmacological and toxicological research and clinical trials.
Veterinary Antibacterial Drugs
Featuring high safety and reliable antibacterial effect, the product can be used in the research and production of antibacterial drugs for pets, livestock and poultry, offering more market options for customers.
Scientific Research Experiment and Standard Product Use
The product has high purity and stable quality, and can be used as laboratory reference substances and standard materials for the development of antibacterial drug detection methods, establishment of quality standards, pharmacokinetic research and other scientific research work, providing reliable support for drug development and quality control.
Packaging and Transportation
As a high-value API, the product adopts vacuum-sealed pharmaceutical-grade aluminum foil bags. It is equipped with moisture-proof cardboard drums or plastic drums on the outer layer with built-in desiccants and buffer protection, effectively blocking light, moisture, oxidation and damage to ensure stable quality during storage and transportation. Packaging specifications are flexible, including 1kg, 5kg, 25kg and other conventional options, and customized packaging is supported to meet different needs of R&D pilot tests, pilot scale-up and large-scale production. The whole transportation process follows pharmaceutical logistics standards. Professional cold chain and chemical logistics are used for domestic transportation, and international transportation complies with UN dangerous goods transportation and API export regulations. Air and sea transportation with full-track tracking is supported to ensure safe and on-time delivery. The product is supported by complete export qualifications and customs declaration documents, enabling efficient customs clearance.
Our Advantages
Stable Production Capacity and In-Stock Supply
The product has stable in-stock supply, which can quickly respond to urgent orders and support long-term bulk reservations to ensure the smooth progress of customers' production plans.
High-Standard Quality Assurance
Sitafloxacin API is produced under full-process GMP with multi-dimensional strict quality inspection. Core indicators are superior to international pharmacopoeia standards, and each batch is provided with a complete test report, ensuring high purity, low impurities and strong stability, meeting global pharmaceutical compliance requirements.
Customized Technical Services
The product can be adjusted in particle size, packaging specifications and other parameters based upon customer needs. One-to-one technical support is provided to assist in sorting out R&D and registration materials, which drives product launch acceleration.
Cost-Effective and Comprehensive After-Sales Service
We offers highly competitive prices with preferential terms for bulk purchases. A fast-response after-sales service is also offered to ensure our customers a worry-free experience.
International Certification and Global Export
The product meets international mainstream pharmacopoeia standards with complete supporting documents. We have mature export experience and it can be safely sold worldwide. Our customers are available to stable and compliant supply of Sitafloxacin with FDA clearance.
FAQ
Hot Tags: sitafloxacin FDA approval, China sitafloxacin FDA approval manufacturers, suppliers, factory
