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Epalrestat CAS 82159-09-9 is the only globally marketed aldose reductase inhibitor API, first-line treatment for diabetic peripheral neuropathy. It blocks the polyol pathway, reduces sorbitol accumulation, relieves symptoms and delays complications. As leading China Epalrestat manufacturers, our Epalrestat Raw Material meets ICH Q7 standards with complete registration support.
Technical Specifications
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Product Name |
Epalrestat API |
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Synonyms |
Epalrestat Powder, Epalrestat Raw Material |
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Characteristics |
A yellow to orange crystalline powder |
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CAS Number |
82159-09-9 |
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Assay |
≥99.0% (HPLC, Subject to the COA) |
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Formula |
C15H13NO3S2 |
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Package |
Technical Package |
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Storage |
stored in a light‑resistant, airtight and dry environment. It is recommended to be kept under refrigeration at 2–8 °C; for long‑term storage, freezing at -20 °C is preferred. Exposure to light, high temperature and moisture |
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Structure |
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Epalrestat Powder is a core specialty API in the field of diabetic complication treatment, and has become the first-line clinical intervention for diabetic peripheral neuropathy due to its exclusive mechanism of action. Relying on full-process GMP production control and closed-loop quality traceability system, we provide high-purity compliant Epalrestat API made in China with Epalrestat fda-aligned quality standards, helping pharmaceutical companies quickly complete registration and commercialization.
Product Features
Epalrestat Raw Material is the only globally approved aldose reductase inhibitor, which fundamentally blocks the polyol pathway and precisely improves clinical symptoms such as numbness and pain of diabetic peripheral neuropathy.
Epalrestat CAS 82159-09-9 is produced in strict compliance with ICH Q7 and GMP standards. Adopting advanced purification technology, it effectively controls impurity content, featuring high purity, excellent batch-to-batch consistency and reliable quality.
We provide complete technical and registration document packages covering all materials required for multi-country submissions, assisting customers who buy Epalrestat to quickly complete drug registration and approval processes in different regions.
We have a large-scale continuous production base with sufficient and flexible capacity, and a full-chain quality traceability system to ensure long-term stable supply of Epalrestat Powder, especially for Bulk Epalrestat orders.
Equipped with a professional technical service team, we provide Customized Epalrestat specifications and process support according to customer needs, and follow up to solve various technical problems in R&D and production.
Full-Cycle Quality Control & Consistent Quality
The quality stability of Epalrestat Raw Material, the only globally approved aldose reductase inhibitor API, directly determines the clinical efficacy and medication safety of diabetic peripheral neuropathy formulations. We always regard quality as the lifeline of the enterprise, and provide global customers with a solid and reliable supply chain guarantee with continuously stable high-quality products.
We have established a full-chain quality control system covering raw material incoming, intermediate synthesis, purification and refining to finished product packaging. Multiple testing nodes are set up in each key process to ensure all links comply with ICH Q7, various pharmacopoeia standards and Epalrestat fda requirements.
Relying on a sound quality management system and advanced analytical testing equipment, we conduct full-item quality inspection on each batch of Epalrestat CAS 82159-09-9, establish complete quality files, and realize full life cycle traceability of products.
By continuously optimizing production processes and quality standards, strictly controlling impurity content and crystal form stability, we ensure high consistency of product quality between different batches. As a professional China Epalrestat factory, we provide long-term stable and reliable API supply.
Application Scenarios
With its unique aldose reductase inhibitory effect and definite clinical benefits, Epalrestat Powder has become a benchmark drug in the field of diabetic peripheral neuropathy treatment. Its application scenarios run through clinical diagnosis and treatment, formulation development and global pharmaceutical supply chain, bringing treatment hope to tens of millions of diabetic patients worldwide.
Epalrestat Raw Material is widely used in endocrinology and neurology departments of medical institutions at all levels to improve symptoms of peripheral neuropathy such as limb numbness, tingling and hypoesthesia in diabetic patients. Early intervention can effectively delay the progression of nerve damage and reduce the risk of disability.
As a core API, it can be used to develop various oral dosage forms such as conventional tablets, dispersible tablets and capsules, adapting to the medication needs of patients of different ages and swallowing abilities. Formulations made from it have obtained Epalrestat fda recognition in multiple regions.
It has been approved for marketing and included in the medical insurance catalog in many Asian countries. With clear therapeutic advantages and good safety, it has become a first-line treatment for diabetic peripheral neuropathy worldwide. We keep sufficient Epalrestat Raw Material in stock to meet the growing market demand.
Packaging and Transportation
Professional and compliant packaging and transportation are the last key line of defense to ensure the quality of APIs. We customize a full-process logistics solution for the physical and chemical properties of Epalrestat CAS 82159-09-9, and strictly control the whole process from packaging material selection to terminal delivery to ensure stable and undamaged product quality.
We use pharmaceutical-grade special packaging materials, with standard specifications including 1kg aluminum foil bags, 25kg cardboard drums and other options. The inner layer is double-sealed to effectively isolate external pollution and meet different batch production and R&D needs of Epalrestat Powder.
All packages have passed strict moisture-proof, light-proof and anti-oxidation verification. The outer drum is clearly marked with product name, CAS number, batch number, validity period and transportation warning signs to realize full traceability of each batch of Epalrestat Raw Material.
We strictly follow international pharmaceutical transportation regulations, adopt closed special vehicles for the whole journey, and are equipped with real-time temperature and humidity monitoring systems and shock-proof buffer measures to ensure that the product quality is not affected during transportation, meeting Epalrestat fda transportation requirements.
We provide customized packaging services according to customers' special needs, and simultaneously provide complete compliance documents such as COA and MSDS. As reliable China Epalrestat suppliers, we support door-to-door delivery in multiple regions around the world to ensure safe and timely delivery of goods.
Our Advantages
We have independent intellectual property rights for the green synthesis process of Epalrestat CAS 82159-09-9, which greatly shortens the reaction steps and reduces three wastes emissions. Through continuous production and precise crystallization technology, the crystal form purity and stability of the product have reached the international top level, and the control of key impurities is far lower than pharmacopoeia requirements.
We have established an industry-leading quality analysis center equipped with cutting-edge testing equipment such as high-resolution mass spectrometry and high-performance liquid chromatography. The professional R&D team continuously optimizes process parameters to realize iterative upgrading of Epalrestat Powder quality and provide customers with more competitive core raw materials.
We have built a complete technology transformation system from laboratory small test, pilot scale-up to industrial production. We can quickly respond to customers' process improvement needs, provide customized impurity research and analytical method development services, and accelerate the R&D process of customers' Epalrestat Raw Material formulations.
We have established long-term strategic cooperation with many well-known scientific research institutions to jointly conduct research on new dosage forms and new indications of Epalrestat fda-compliant products. Our continuous technological innovation capability ensures that we are always at the forefront of the industry and create long-term value for customers.
FAQ
We focus on technological innovation in neuroprotective APIs, with an independently developed To address unmet clinical needs for diabetic peripheral neuropathy, we specialize in specialty APIs and have developed a high-quality production process for Epalrestat CAS 82159-09-9. We will continue to innovate and provide premium Epalrestat Raw Material to support global pharmaceutical partners and benefit more patients worldwide.
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