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Details
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Specifications
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CAS Number
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2641500-53-8
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Molecular Formula
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C26H23N7O2?C4H4O4.H2O
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Molecular Weight
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599.6 g/mol.
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Synonyms
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Benzamide,4-[8-amino-3-[(2S)-1-(1-oxo-2-butyn-1-yl)-2-pyrrolidinyl] imidazo[1,5a] pyrazin-1-yl]-N-2-pyridinyl-, (2Z)-2-butenedioate, hydrate
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Chemical Name
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4-{8-Amino-3-[(2S)-1-(but-2-ynoyl) pyrrolidin-2-yl] imidazo[1,5-a] pyrazin-1-yl}-N-(pyridin-2-yl) benzamide (2Z)-2-butenedioic acid hydrate
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Therapeutic use
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Mantle Cell Lymphoma (MCL), Chronic lymphocytic leukemia (CLL), Small lymphocytic lymphoma (SLL).
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Status
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Tech pack available
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Background
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Acalabrutinib, sold under the brand name Calquence, is a second-generation, small-molecule inhibitor of Bruton's tyrosine kinase (BTK). Developed by Acerta Pharma (now part of AstraZeneca), it was designed to be more selective and potent than earlier BTK inhibitors like ibrutinib.
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Grade
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In-house
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Polymorph
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Form-A & Amorphous.
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Storage Temperature
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Form A: Controlled room temperature (20?C ? 25?C) | Amorphous: Controlled temperature at 2?C ? 8?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.
Acalabrutinib maleate (CAS 2641500-53-8) is the maleate salt of acalabrutinib, a second-generation, orally active, small-molecule inhibitor of Bruton’s tyrosine kinase (BTK). Marketed under the brand name Calquence, acalabrutinib was developed for high BTK selectivity and potency, and is used to treat B-cell malignancies including mantle cell lymphoma (MCL), chronic lymphocytic leukaemia (CLL), and small lymphocytic lymphoma (SLL). The maleate salt supports a tablet presentation that can be taken alongside acid-reducing agents, addressing a limitation of the earlier free-base formulation.
With a molecular formula of C₂₆H₂₃N₇O₂·C₄H₄O₄·H₂O and a molecular weight of 599.6 g/mol, acalabrutinib maleate is a small-molecule kinase inhibitor that binds covalently to the BTK active site, blocking B-cell receptor signalling and inhibiting the proliferation and survival of malignant B cells. As one of the leading targeted therapies in haemato-oncology, the molecule has driven strong global demand for reliable acalabrutinib maleate API from established manufacturers and suppliers across regulated and emerging markets.
As established API manufacturers in India, Shilpa Pharma Lifesciences supplies acalabrutinib maleate 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.
Acalabrutinib maleate 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 a selective, covalent BTK inhibitor, the molecule targets Bruton’s tyrosine kinase within the B-cell receptor pathway, suppressing the signalling that drives growth and survival in B-cell lymphomas and leukaemias, which underpins its use across mantle cell lymphoma, chronic lymphocytic leukaemia, and small lymphocytic lymphoma.
In a development and manufacturing context, the acalabrutinib maleate 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 can supply acalabrutinib maleate in both the crystalline Form A and the amorphous form, giving formulators the flexibility to select the solid-state form best suited to their dosage design and bioavailability targets.
As established acalabrutinib maleate suppliers, Shilpa Pharma provides material exclusively to qualified pharmaceutical manufacturers, biotechnology companies, and international trading partners for development and manufacturing use under applicable regulatory frameworks.
As a member of the BTK inhibitor class, acalabrutinib’s clinical safety profile is characterised by class-related effects. Commonly reported adverse effects include headache, diarrhoea, decreased blood counts (such as neutropenia, anaemia, and thrombocytopenia), upper respiratory tract infections, bruising, and fatigue. Class-associated risks noted in product labelling include bleeding, infections, cytopenias, cardiac arrhythmias such as atrial fibrillation, and second primary malignancies. Treatment is initiated and monitored by qualified oncologists in accordance with the approved product information.
As an oncology active pharmaceutical ingredient, acalabrutinib maleate 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). Storage depends on the solid-state form: the crystalline Form A should be stored at controlled room temperature (20°C to 25°C), while the amorphous form should be stored under refrigerated conditions at 2°C to 8°C, in both cases protected from moisture and light.
This information is provided for scientific and technical reference to pharmaceutical professionals and does not constitute medical advice.
The cost of acalabrutinib maleate varies according to order volume, required specifications, solid-state form, 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 acalabrutinib maleate pricing, bulk quantity cost estimates, and commercial supply terms, pharmaceutical and biotechnology buyers are invited to contact Shilpa Pharma directly. As trusted acalabrutinib maleate suppliers and exporters, our team provides a tailored quotation based on your required quantity, grade, polymorphic form, 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 acalabrutinib maleate 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 acalabrutinib maleate API, partners choose Shilpa Pharma for:
Partner with Shilpa Pharma, a trusted acalabrutinib maleate 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*
