Details | Specifications |
|---|---|
CAS Number |
50-35-1 |
Molecular Formula |
C13H10N2O4 |
Molecular Weight |
258.2 |
Synonyms |
α-phthalimidoglutarimide, N-phthaloylglutamimide |
Chemical Name |
2-(2,6-dioxo-3-piperidinyl)-1H-isoindole-1,3(2H)-dione |
Grade |
USP/ In-House |
Polymorph |
Alpha (α) Form |
GTI and NI |
NA |
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.
Thalidomide, identified by its chemical name 2-(2,6-dioxo-3-piperidinyl)-1H-isoindole-1,3(2H)-dione and CAS number 50-35-1, stands as a crucial active pharmaceutical ingredient (API) within the pharmaceutical landscape. This API is a synthetic derivative of glutamic acid, characterized by its phthalimido and glutarimide rings, which contribute to its distinctive molecular architecture and pharmacological properties. With a molecular weight of 258.2, Thalidomide is classified as an immunomodulatory agent, exerting its therapeutic effects through multiple mechanisms including inhibition of TNF-α production, anti-angiogenesis, and modulation of cellular immune responses. Its strategic importance lies in its ability to address complex disease pathologies where these mechanisms are implicated, making it an indispensable component for specific therapeutic regimens. Shilpa Pharma, as one of the prominent Thalidomide manufacturers in India, ensures the production of this API to stringent pharmacopoeial standards, including USP and our rigorous in-house specifications, guaranteeing consistent quality and purity for global pharmaceutical manufacturers. The precise control over its stereochemistry and polymorphic forms is paramount, given its pharmacological profile, and our manufacturing processes are designed to maintain these critical quality attributes. Our commitment to supplying high-quality pharmaceutical APIs underscores our role in supporting the development and commercialization of essential medicines worldwide, providing a reliable source for this complex molecule.
The industrial and pharmaceutical formulation applications of Thalidomide API are primarily centered on its incorporation into oral solid dosage forms, reflecting its systemic therapeutic action. As a compound with inherently low aqueous solubility, formulation scientists must employ specific strategies to ensure optimal bioavailability and consistent drug release. Techniques such as micronization, solid dispersion, or the use of appropriate excipients that enhance solubility and dissolution rates are often critical during formulation development. Compatibility with a range of common pharmaceutical excipients is generally good, though careful evaluation of potential interactions during pre-formulation studies is always recommended to mitigate stability issues or processing challenges. Thalidomide’s physical properties, including its crystallinity and particle size distribution, significantly influence its compressibility and flow characteristics, which are vital for efficient tableting or capsule filling operations. Shilpa Pharma offers comprehensive support for these formulation challenges through our CDMO services, assisting clients from initial formulation development and excipient selection through to process optimization and technology transfer. Our expertise enables us to support the creation of robust manufacturing processes for Thalidomide-containing products, whether for immediate-release or specialized modified-release applications, ensuring the API performs optimally within the final dosage form. As a dedicated Thalidomide supplier from India, we understand the nuances of working with such a critical API and provide the necessary technical and developmental assistance to our global partners.
Ensuring the integrity and safety of Thalidomide API throughout its lifecycle is paramount, demanding strict adherence to recommended storage conditions and handling guidelines for industrial personnel. This API should be stored in tightly sealed containers, protected from light and moisture, typically at controlled room temperature (e.g., 20°C to 25°C), to preserve its chemical stability and prevent degradation. Our packaging solutions are designed to provide robust protection against environmental factors, utilizing materials that do not interact adversely with the API. Shilpa Pharma provides comprehensive data on shelf life and retest periods, established through rigorous stability studies conducted under ICH-compliant conditions. For personnel handling Thalidomide in manufacturing or laboratory settings, strict adherence to good manufacturing practices (GMP) and occupational safety protocols is mandatory. This includes the use of appropriate personal protective equipment (PPE) such as gloves, eye protection, and respiratory masks, along with ensuring adequate local exhaust ventilation to minimize exposure. Known incompatibilities or stability-sensitive conditions, such as exposure to strong acids or bases, are thoroughly documented in our Safety Data Sheets (SDS). Furthermore, Shilpa Pharma meticulously assesses regulatory classifications, including relevance to REACH regulations and adherence to ICH Q3D guidelines for elemental impurities, providing complete transparency and compliance documentation. Our quality assurance package for Thalidomide, as provided by a leading Thalidomide exporter India, includes a Certificate of Analysis (CoA), Certificate of Conformance, detailed SDS, comprehensive impurity profiling, and residual solvent analysis, assuring our clients of the API’s quality and regulatory readiness.
The commercial and procurement factors influencing the pricing of pharmaceutical APIs like Thalidomide are multifaceted, reflecting the intricate balance between manufacturing complexity, regulatory requirements, and global supply chain dynamics. Key drivers include the purity specification demanded by compendial standards (e.g., USP) or client-specific needs, the batch size required, and the extensive documentation necessary, such as US-DMFs or CEPs, which represent significant investment in regulatory compliance and quality assurance. Raw material costs, the origin and vertical integration of the supply chain, and fluctuations in global currency markets also play a substantial role in determining the final API cost. Indian GMP manufacturers, including Shilpa Pharma, are uniquely positioned to offer highly competitive pricing for Thalidomide without compromising on quality or regulatory adherence. This advantage stems from efficient manufacturing processes, economies of scale, and a well-established ecosystem for pharmaceutical production. Sourcing directly from a vertically integrated manufacturer like Shilpa Pharma provides distinct benefits over trading intermediaries, offering greater transparency, traceability, and consistency in supply, often at a more favorable cost. We accommodate all order sizes, from small research quantities essential for early-stage development to full commercial volumes, with flexible Minimum Order Quantities (MOQs) to meet diverse client needs. Establishing long-term supply agreements further enhances cost predictability and supply chain stability for our partners. As one of the prominent Thalidomide manufacturers in India, we are committed to providing value through quality and reliability. To receive a tailored quotation or discuss supply requirements, buyers are encouraged to contact us directly.
Pharmaceutical manufacturers, generic drug companies, CDMOs, and research institutions worldwide consistently choose Shilpa Pharma as their preferred partner for high-quality APIs, including Thalidomide, due to our unwavering commitment to excellence and comprehensive service offerings. Our manufacturing infrastructure is GMP-certified and ISO-compliant, reflecting our dedication to the highest international quality standards, which is critical for an API of Thalidomide’s significance. We provide robust regulatory dossier support, including US-DMFs, CEP/EDMFs, and Certificates of Pharmaceutical Product (COPP), facilitating seamless market entry and regulatory approvals for our global clientele. Our advanced analytical capabilities, encompassing state-of-the-art HPLC, GC, Karl Fischer titration, and particle size analysis, ensure meticulous characterization and consistent quality of every batch. Shilpa Pharma’s extensive about Shilpa Pharma commitment to client success extends through our comprehensive CDMO services, where we offer expertise from custom synthesis and process development to scale-up and technology transfer, enabling partners to bring complex molecules to market efficiently. With decades of experience as a Thalidomide manufacturer and exporter, we possess a profound understanding of global logistics and regulatory nuances, successfully serving markets across North America, Europe, Asia-Pacific, Latin America, the Middle East, and Africa. We provide dedicated technical support, addressing formulation queries and offering scientific insights, ensuring that our clients receive not just an API, but a complete solution. Our auditable supply chain guarantees transparency and reliability, while our straightforward procurement process, from initial inquiry to final delivery, is designed for maximum efficiency and client satisfaction, making us a trusted partner in the pharmaceutical industry.
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Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*
