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Details
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Specifications
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CAS Number
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1691249-45-2
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Molecular Formula
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C27H29N5O3
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Molecular Weight
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471.55 g/mol.
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Synonyms
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(S)-7-(1-acryloylpiperidin-4-yl)-2-(4-phenoxy phenyl)4,5,6,7-tetrahydropyrazolo[1,5-a]pyrimidine-3-carboxamide.
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Chemical Name
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4-amino-1-[(2R,4R,5R)-3,3-difluoro-4-hydroxy-5-(hydroxymethyl) oxolan-2-yl] pyrimidin-2-one; hydrochloride
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Therapeutic use
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Zanubrutinib is a kinase inhibitor used to treat mantle cell lymphoma, a type of B-cell non-Hodgkin lymphoma, in adults who previously received therapy.
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Status
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Tech pack available
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Background
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Zanubrutinib (marketed as Brukinsa) is a next-generation, oral, small-molecule inhibitor of Bruton?s tyrosine kinase (BTK) developed by BeiGene. It was designed to specifically target BTK to treat various B-cell malignancies.
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Grade
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In-house
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Polymorph
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Form A and 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.
Zanubrutinib API (CAS 1691249-45-2) is a next-generation, orally active, small-molecule inhibitor of Bruton’s tyrosine kinase (BTK), developed for the treatment of a range of B-cell malignancies. Marketed under the brand name Brukinsa, zanubrutinib was engineered for high BTK selectivity, providing potent and sustained target inhibition with reduced off-target activity. It is used in indications including mantle cell lymphoma, chronic lymphocytic leukaemia, Waldenström’s macroglobulinaemia, and marginal zone lymphoma.
With a molecular formula of C₂₇H₂₉N₅O₃ and a molecular weight of 471.55 g/mol, zanubrutinib 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 fastest-growing targeted therapies in haemato-oncology, the molecule has driven strong global demand for reliable zanubrutinib manufacturers and suppliers across regulated and emerging markets.
As established API manufacturers in India, Shilpa Pharma Lifesciences supplies zanubrutinib 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.
Zanubrutinib 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 multiple haematological indications.
In a development and manufacturing context, the API supports formulation and oral solid dosage (capsule and 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 zanubrutinib 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 zanubrutinib 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, zanubrutinib’s clinical safety profile is characterised by class-related effects. Commonly reported adverse effects include decreased blood counts (such as neutropenia, thrombocytopenia, and anaemia), upper respiratory tract infections, bruising, rash, and musculoskeletal pain. Class-associated risks noted in product labelling include bleeding, infections, cytopenias, cardiac arrhythmias, 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, zanubrutinib 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 zanubrutinib 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 zanubrutinib pricing, bulk quantity cost estimates, and commercial supply terms, pharmaceutical and biotechnology buyers are invited to contact Shilpa Pharma directly. As trusted zanubrutinib 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 zanubrutinib 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 zanubrutinib, partners choose Shilpa Pharma for:
Partner with Shilpa Pharma, a trusted zanubrutinib 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*
