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Details
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Specifications
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CAS Number
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1421373-66-1
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Molecular Formula
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C28H33N7O2.CH4O3S
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Molecular Weight
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595.7 g/mol.
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Synonyms
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N-(2-{2-(dimethylamino)ethylamino}-4-methoxy-5-{[4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide mesylate salt
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Chemical Name
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N-(2-{2-(dimethylamino)ethylamino}-4-methoxy-5-{[4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide mesylate salt
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Therapeutic use
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Osimertinib is to treat advanced or recurrent cancers with BRCA mutations, including ovarian, fallopian tube, peritoneal, HER2-negative breast, pancreatic, and prostate cancers. It functions by preventing cancer cells from repairing their DNA, causing them to die.
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Status
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Tech pack available
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Background
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Osimertinib mesylate (commonly sold under the brand name Tagrisso) is a third-generation, oral, irreversible Epidermal Growth Factor Receptor (EGFR) tyrosine kinase inhibitor (TKI). Developed by AstraZeneca, it is specifically designed to target the T790M resistance mutation for non-small cell lung cancer (NSCLC)
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Grade
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In-house
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Polymorph
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Form-B
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Storage Temperature
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Controlled room temperature (20?C ? 25?C)
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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.
Osimertinib (CAS 1421373-66-1) API, supplied as the mesylate salt, is a third-generation, orally active, irreversible inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase. Marketed under the brand name Tagrisso and developed by AstraZeneca, osimertinib selectively targets EGFR-activating mutations along with the T790M resistance mutation, while largely sparing wild-type EGFR. It is used in the treatment of EGFR mutation-positive non-small cell lung cancer (NSCLC), including first-line, resistance (T790M), and adjuvant settings.
With a molecular formula of C₂₈H₃₃N₇O₂·CH₄O₃S and a molecular weight of 595.7 g/mol, osimertinib mesylate is a small-molecule kinase inhibitor that binds irreversibly to the EGFR ATP-binding site, blocking the downstream signalling that drives tumour growth and survival. Its activity against central nervous system metastases is a notable feature of the molecule. As one of the leading targeted therapies in oncology, osimertinib has driven strong global demand for a reliable osimertinib API from established manufacturers and suppliers across regulated and emerging markets.
As established API manufacturers in India, Shilpa Pharma Lifesciences supplies osimertinib as a bulk active pharmaceutical ingredient to pharmaceutical and biotechnology partners worldwide. Backed by a complete technical package and integrated CDMO services, Shilpa Pharma supports global partners from early development through commercial-scale manufacturing and supply.
Osimertinib is supplied as a drug substance (bulk API) for use by pharmaceutical and biotechnology manufacturers in the development and production of oral oncology solid dosage forms. As an irreversible EGFR tyrosine kinase inhibitor, the molecule binds covalently to mutant forms of the receptor, suppressing the EGFR-driven signalling that promotes proliferation and survival in EGFR mutation-positive non-small cell lung cancer, including tumours carrying the T790M resistance mutation.
In a development and manufacturing context, the osimertinib API supports formulation and oral solid dosage (tablet) development, analytical method development and validation, impurity profiling and reference standard qualification, polymorph and stability studies, and scale-up to clinical and commercial supply. Shilpa Pharma supplies osimertinib in the defined crystalline Form B, supporting consistent solid-state quality and reproducible processing during oral dosage form development.
Osimertinib is provided exclusively to qualified pharmaceutical manufacturers, biotechnology companies, and international trading partners for development and manufacturing use under applicable regulatory frameworks.
As an EGFR tyrosine kinase inhibitor, osimertinib’s clinical safety profile is characterised by class-related effects. Commonly reported adverse effects include diarrhoea, rash, dry skin, nail changes such as paronychia, stomatitis, and decreased appetite. More serious risks noted in product labelling include interstitial lung disease and pneumonitis, cardiac effects such as QTc-interval prolongation and reduced left ventricular ejection fraction, and severe cutaneous reactions. Treatment is initiated and monitored by qualified oncologists in accordance with the approved product information.
As an oncology active pharmaceutical ingredient, osimertinib should be handled as a potent compound, using appropriate containment, engineering controls, and personal protective equipment in line with its occupational exposure assessment and Safety Data Sheet (SDS). The API should be stored at controlled room temperature (20°C to 25°C), protected from moisture and light, to maintain stability and quality.
This information is provided for scientific and technical reference to pharmaceutical professionals and does not constitute medical advice.
The cost of osimertinib varies according to order volume, required specifications, packaging, documentation, and delivery destination. As bulk API pricing is project- and quantity-specific, Shilpa Pharma does not publish standard list pricing for this product.
For current osimertinib pricing, bulk quantity cost estimates, and commercial supply terms, pharmaceutical and biotechnology buyers are invited to contact Shilpa Pharma directly. As a trusted osimertinib supplier and exporter, Shilpa Pharma provides a tailored quotation based on the required quantity, grade, and regulatory documentation needs, along with competitive, cost-effective supply options for both development-scale and commercial-scale requirements.
Shilpa Pharma Lifesciences is one of the most trusted osimertinib manufacturers in India and a full-scale CDMO partner, supplying high-quality active pharmaceutical ingredients to pharmaceutical and biotech companies across more than 80 countries. For osimertinib API, partners choose Shilpa Pharma for:
Partner with Shilpa Pharma, a trusted osimertinib manufacturer and exporter, for a dependable, scalable, and cost-effective global source of this API.
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Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*
