Details | Specifications |
|---|---|
CAS Number |
319460-85-0 |
Molecular Formula |
C22H18N4OS |
Molecular Weight |
386.47 |
Synonyms |
AG-013736 and AG-13736 |
Chemical Name |
(E)-N-Methyl-2-((3-(2-pyridin-2-yl)vinyl)-1H-indazol-6-yl)thio)benzamide |
Grade |
In-house |
Polymorph |
SAB-I |
GTI and NI |
Risk Assessment available |
DMF Availability |
Available |
Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*Â
Disclaimer:Â
The information provided on this webpage is based on the best available knowledge at the time of publication; however, accuracy and completeness are not guaranteed. Product specifications may change without notice. It is the responsibility of the purchaser or user to verify suitability and compliance. This product is intended for research use only and is not approved for human consumption.
Shilpa Pharma proudly presents Axitinib, a highly potent and selective active pharmaceutical ingredient (API) crucial for advanced oncology treatments. Identified by its chemical name (E)-N-Methyl-2-((3-(2-pyridin-2-yl)vinyl)-1H-indazol-6-yl)thio)benzamide and CAS Number 319460-85-0, Axitinib is a small molecule, oral tyrosine kinase inhibitor (TKI) belonging to the indazole class. Its molecular weight is 386.47, reflecting a precisely engineered structure designed for targeted therapeutic action.
Axitinib functions by selectively inhibiting the vascular endothelial growth factor receptors (VEGFR-1, VEGFR-2, and VEGFR-3). These receptors play a pivotal role in angiogenesis, the process by which new blood vessels form, supplying nutrients to tumors and facilitating their growth and metastasis. By blocking these specific receptor tyrosine kinases, Axitinib effectively disrupts the signaling pathways essential for tumor angiogenesis, thereby impeding tumor proliferation and survival. This targeted mechanism makes it an indispensable component in the treatment of certain advanced cancers, particularly renal cell carcinoma.
As one of the prominent Axitinib manufacturers in India, Shilpa Pharma ensures that this API is produced to stringent in-house quality specifications, aligning with the highest global pharmacopoeial standards and regulatory expectations. Our commitment to Good Manufacturing Practices (GMP) and ISO certification underscores the reliability and purity of our Axitinib API. Pharmaceutical manufacturers worldwide depend on high-quality, consistently produced APIs like Axitinib to develop life-saving medications. Shilpa Pharma supports this critical demand by offering a dependable supply chain for our extensive range of pharmaceutical APIs, ensuring timely delivery and comprehensive regulatory support for our global clientele across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa.
Axitinib, with its precise therapeutic action, is predominantly formulated into oral solid dosage forms, typically tablets. Its physicochemical properties, including its relatively low aqueous solubility, necessitate careful consideration during pharmaceutical formulation development. Shilpa Pharma, as a leading Axitinib supplier from India, offers comprehensive support to pharmaceutical manufacturers in navigating these formulation complexities, ensuring optimal bioavailability and stability of the final drug product.
The successful formulation of Axitinib requires a thorough understanding of its solubility characteristics and potential interactions with excipients. Due to its classification, often falling under BCS Class II or IV, strategies for solubility enhancement such as micronization, the use of amorphous solid dispersions, or co-crystallization techniques are frequently employed. Careful selection of excipients—including binders, disintegrants, diluents, and lubricants—is paramount to ensure chemical compatibility, maintain API stability, and achieve desired dissolution profiles. Our technical experts can provide guidance on excipient selection and pre-formulation studies to optimize the drug product’s performance and manufacturability.
Manufacturing Axitinib drug products demands specialized processing techniques and facilities, particularly given its potent nature. Techniques such as direct compression, dry granulation, or wet granulation may be utilized, with strict control over particle size distribution to ensure content uniformity and consistent dissolution rates. Shilpa Pharma extends its expertise through comprehensive CDMO services, assisting clients from early-stage formulation development through process scale-up and technology transfer. This includes analytical method development and validation, stability studies, and manufacturing support for clinical trial materials and commercial batches. Our capabilities ensure that clients can efficiently transition from API sourcing to a market-ready drug product, benefiting from our integrated approach and deep understanding of complex API processing requirements.
The safe handling and storage of Axitinib API are critical to maintaining its purity, efficacy, and ensuring personnel safety within industrial manufacturing settings. As a potent active pharmaceutical ingredient, Axitinib requires adherence to strict protocols for its lifecycle management, from receipt and storage to processing and waste disposal. Shilpa Pharma provides comprehensive safety data sheets (SDS) and technical guidance to ensure all industrial and regulatory safety requirements are met by our global clientele.
Axitinib API should be stored in its original, unopened container, protected from direct light, moisture, and extreme temperatures. The recommended storage temperature typically falls within a controlled room temperature range, such as 2-8°C or 15-25°C, to preserve its chemical integrity over its designated shelf life. Our packaging typically involves triple-laminated polyethylene bags sealed inside HDPE drums or fiber drums, designed to provide superior barrier protection against environmental factors. The retest period for Axitinib is determined through rigorous stability studies conducted under ICH-compliant conditions, ensuring that the API maintains its quality attributes throughout its lifecycle. As a responsible Axitinib exporter India, Shilpa Pharma ensures all packaging and labeling comply with international shipping regulations.
Due to the potency of Axitinib, industrial handling requires appropriate engineering controls, such as isolators or downflow booths, and the use of personal protective equipment (PPE) including respiratory protection, chemical-resistant gloves, and eye protection. Adequate ventilation in manufacturing areas is essential to minimize airborne exposure. Shilpa Pharma’s commitment to quality is further demonstrated by our comprehensive quality documentation, which includes detailed Certificates of Analysis (CoA), Certificates of Conformance (CoC), full impurity profiling (including related substances and elemental impurities in accordance with ICH Q3D guidelines), and residual solvent analysis. These documents provide complete transparency and assurance of product quality, assisting our clients with their regulatory submissions and compliance obligations worldwide. Our manufacturing processes are designed to mitigate potential incompatibilities and stability-sensitive conditions, ensuring a consistent and high-quality supply of Axitinib.
The pricing of active pharmaceutical ingredients such as Axitinib is influenced by a multifaceted array of factors, reflecting the complexity of synthesis, quality assurance, and regulatory compliance. Key drivers include the purity specification required by the client, the batch size, ranging from research quantities to full commercial volumes—and the specific regulatory documentation, such as US-DMF or CEP, that accompanies the API. Furthermore, the origin and integrity of the supply chain, the fluctuating costs of critical raw materials, and global currency exchange rates all contribute to the final commercial quotation. Shilpa Pharma, as one of the leading Axitinib manufacturers in India, is strategically positioned to offer highly competitive pricing without compromising on the stringent quality standards demanded by the global pharmaceutical industry.
Sourcing Axitinib directly from a vertically integrated manufacturer like Shilpa Pharma provides significant advantages over engaging with trading intermediaries. Our integrated operations allow for greater control over the entire production process, from key intermediates to the final API, which translates into enhanced quality assurance, supply chain reliability, and often, more favourable pricing. This direct relationship eliminates additional mark-ups and provides transparency regarding the product’s provenance. We understand that our global clientele, spanning research institutions to large generic drug companies, has diverse needs. Therefore, Shilpa Pharma accommodates all order sizes, from small R&D quantities to large commercial volumes, with flexible Minimum Order Quantities (MOQs) tailored to specific project requirements.
For pharmaceutical manufacturers seeking long-term supply stability and cost predictability, Shilpa Pharma offers the opportunity for long-term supply agreements. These partnerships are designed to provide consistent pricing, guaranteed supply, and dedicated technical support, fostering a collaborative environment for sustained success. Such agreements are particularly beneficial in managing market volatilities and ensuring uninterrupted production schedules for critical oncology medications. To receive a tailored quotation or discuss supply requirements, buyers are encouraged to contact us directly.
Choosing Shilpa Pharma as your partner for Axitinib API means aligning with a manufacturer renowned for its unwavering commitment to quality, regulatory excellence, and customer-centric service. Our position as a leading Axitinib manufacturer and exporter is built upon a foundation of state-of-the-art, GMP-certified manufacturing infrastructure and an extensive track record of successful global exports. Pharmaceutical manufacturers, generic drug companies, CDMOs, and research organizations across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa consistently choose Shilpa Pharma for our comprehensive capabilities and reliable supply.
A critical differentiator for Shilpa Pharma is our robust regulatory affairs expertise. We provide comprehensive documentation support, including US-DMF filings, Certificates of Suitability (CEP/EDMF), and Certificates of Pharmaceutical Product (COPP), facilitating seamless market approvals for our clients worldwide. Our in-house analytical laboratories are equipped with advanced instrumentation, including High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Karl Fischer titrators for moisture content, and particle size analyzers. This ensures rigorous quality control at every stage of Axitinib production, guaranteeing purity, consistent quality, and adherence to specified parameters.
Beyond API manufacturing, Shilpa Pharma offers integrated about Shilpa Pharma CDMO services, encompassing custom synthesis, process optimization, scale-up, and technology transfer. This allows clients to streamline their development pipelines, benefiting from a single, trusted partner from early-stage research to commercial manufacturing. Our extensive experience in worldwide export means we understand the nuances of international logistics, customs, and diverse regulatory landscapes. We provide dedicated technical support for formulation queries, ensuring our clients receive expert assistance throughout their product development journey. Our auditable supply chain offers complete transparency and traceability, providing peace of mind. The procurement process, from initial inquiry to final delivery, is designed to be efficient and straightforward, making Shilpa Pharma the preferred choice for high-quality Axitinib API.
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Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*
