Details | Specifications |
|---|---|
CAS Number |
1310726-60-3 |
Molecular Formula |
C17H19F3N6O |
Molecular Weight |
380.37 |
Synonyms |
NA |
Chemical Name |
(3S)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide |
Grade |
NA |
Polymorph |
NA |
GTI and NI |
NA |
DMF Availability |
NA |
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.
Upadacitinib, identified by CAS Number 1310726-60-3, is a highly selective, orally bioavailable small molecule belonging to the pyrrolidine-1-carboxamide class, distinguished by its unique chemical structure: (3S)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide. With a molecular weight of 380.37, this active pharmaceutical ingredient (API) functions as a targeted immunomodulator, specifically a Janus kinase (JAK) inhibitor. Its mechanism of action involves the selective inhibition of JAK1, thereby modulating cytokine signaling pathways that are implicated in various physiological processes. This targeted approach offers a precise intervention at the molecular level, distinguishing it from broader immunosuppressive agents. As a critical API, Upadacitinib holds significant strategic importance for pharmaceutical manufacturers globally, enabling the development of advanced therapeutic products. Shilpa Pharma is among the leading Upadacitinib manufacturers in India, adhering to stringent quality benchmarks and regulatory requirements. We provide Upadacitinib API that meets the highest pharmacopoeial standards, ensuring its suitability for diverse pharmaceutical applications across regulated markets. Our commitment to quality and compliance underpins our extensive portfolio of pharmaceutical APIs, manufactured in GMP-certified facilities.
Upadacitinib, as a potent API, is primarily formulated into oral solid dosage forms, typically immediate-release tablets or capsules, designed for systemic absorption. Its physicochemical properties, including solubility characteristics and particle size distribution, are critical considerations during pre-formulation and formulation development. The API exhibits specific solubility profiles that necessitate careful selection of excipients to ensure optimal dissolution and bioavailability. Compatibility studies with common pharmaceutical excipients are paramount to prevent degradation or interaction that could compromise product stability or therapeutic efficacy. When formulating Upadacitinib, factors such as crystallinity, polymorphism, and hygroscopicity must be thoroughly assessed to ensure consistent product performance and shelf life. For solid oral dosage forms, its compressibility and flow properties influence the efficiency of manufacturing processes like direct compression or granulation. Shilpa Pharma, as a distinguished Upadacitinib supplier from India, understands these intricate formulation challenges. Our comprehensive CDMO services are designed to support pharmaceutical clients through every stage of development, from initial formulation screening and optimization to process scale-up and technology transfer. We offer expert guidance on excipient selection, analytical method development, and process validation to ensure the successful and efficient production of high-quality Upadacitinib-containing drug products, accommodating various formulation strategies, including potential for modified-release systems.
The safe handling and storage of Upadacitinib are paramount to preserve its purity, potency, and stability, critical for its industrial application in pharmaceutical manufacturing. Recommended storage conditions typically involve maintaining the API in a tightly sealed container, protected from light and moisture, at controlled room temperature, generally between 2°C and 8°C, or as specified in the Certificate of Analysis (CoA). Packaging requirements are stringent, often utilizing double-polyethylene bags within high-density polyethylene drums or aluminum containers, purged with inert gas to minimize oxidative degradation. The shelf life and retest period are established through comprehensive stability studies in accordance with ICH guidelines. For personnel handling Upadacitinib, adherence to Good Manufacturing Practices (GMP) is mandatory, including the use of appropriate Personal Protective Equipment (PPE) such as gloves, safety glasses, and respiratory protection, especially during weighing and dispensing operations. Adequate ventilation systems, such as local exhaust ventilation (LEV), are essential to control airborne particulate exposure. Known incompatibilities or stability-sensitive conditions, such as exposure to strong acids, bases, or oxidizing agents, must be strictly avoided. Shilpa Pharma, a leading Upadacitinib exporter India, ensures that all our APIs meet rigorous regulatory classifications, including compliance with ICH Q3D guidelines for elemental impurities and comprehensive impurity profiling. We provide extensive quality documentation, including detailed Certificates of Analysis, Certificates of Conformance, Safety Data Sheets (SDS), and reports on residual solvents analysis, providing our clients with complete transparency and assurance of product quality and regulatory compliance.
The commercial procurement of pharmaceutical APIs like Upadacitinib is influenced by a multitude of factors, extending beyond the mere cost of raw materials. Key determinants of pricing include the API’s purity specification, the required batch size, and the extensive regulatory documentation, such as US-DMF or CEP, necessary for market authorization. The origin of the supply chain, the complexity of synthesis, and global currency fluctuations also significantly impact pricing structures. Indian GMP manufacturers, such as Shilpa Pharma, are uniquely positioned to offer highly competitive pricing for Upadacitinib without compromising on the stringent quality and regulatory standards demanded by global pharmaceutical markets. This competitive edge often stems from strategic vertical integration, which allows for greater control over the entire manufacturing process, from key starting materials to the final API. This integration minimizes reliance on external intermediaries, thereby reducing costs, enhancing supply chain security, and improving traceability. Shilpa Pharma is adept at accommodating all order sizes, from small research quantities essential for early-stage development to large commercial volumes, offering flexible Minimum Order Quantities (MOQs) to meet diverse client needs. Furthermore, establishing long-term supply agreements with Shilpa Pharma provides pharmaceutical manufacturers with predictable pricing and enhanced supply chain stability, crucial for consistent drug product manufacturing. To receive a tailored quotation or discuss supply requirements, buyers are encouraged to contact us directly.
Choosing Shilpa Pharma as your partner for Upadacitinib API ensures a strategic advantage rooted in our unwavering commitment to quality, compliance, and client-centric services. Pharmaceutical manufacturers, generic drug companies, CDMOs, and research organizations worldwide rely on our robust capabilities. Our manufacturing facilities are not only ISO-certified but also strictly GMP-compliant, guaranteeing that Upadacitinib is produced under the most rigorous quality management systems. We possess comprehensive regulatory dossier capabilities, including readily available US-DMF, CEP/EDMF, and Certificate of Pharmaceutical Product (COPP), facilitating seamless market authorization processes for our global clientele across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa. Our advanced analytical capabilities, encompassing state-of-the-art HPLC, GC, Karl Fischer titration, and particle size analysis, ensure the consistent quality and characterization of every batch. Beyond API manufacturing, our extensive about Shilpa Pharma services include bespoke CDMO offerings, from custom synthesis and process optimization to scale-up and technology transfer, providing integrated solutions for complex development projects. As a seasoned Upadacitinib manufacturer and exporter, Shilpa Pharma offers dedicated technical support for formulation queries and challenges, ensuring a smooth transition from API to finished drug product. Our auditable supply chain provides transparency and security, while our straightforward procurement process, from initial inquiry to final delivery, is designed for maximum efficiency and reliability, making us the preferred choice for critical pharmaceutical raw materials.
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Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*
