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Details
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Specifications
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CAS Number
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915087-33-1
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Molecular Formula
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[C21H16F4N4O2S](https://pubchem.ncbi.nlm.nih.gov/)
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Molecular Weight
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464.44 g/mol.
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Synonyms
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Enzalutamideum
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Chemical Name
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4-(3-(4-cyano-3-(trifluoromethyl)phenyl)-5,5-dimethyl-4-oxo-2-thioxoimidazolidin-1-yl)-2-fluoro-N-methylbenzamide
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Common name
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Enzalutamide
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Therapeutic use
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-
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Background
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Enzalutamide is used to treat certain types of prostate cancer. Enzalutamide is in a class of medications called androgen receptor inhibitors. It works by blocking the effects of androgen (a male reproductive hormone) to stop the growth and spread of cancer cells.
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Grade
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USP
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Polymorph
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Form A
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GTI
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Risk assessment report available
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Nitrosamines
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Risk assessment report available
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DMF Availability
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USDMF# 30260
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Manufacturing batch size
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20.0 Kg
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Production capacity
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Annual capacity is 1.0 - 1.5 tonnes
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Stability data
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Available
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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.
Enzalutamide is a second-generation androgen receptor inhibitor, a small-molecule active pharmaceutical ingredient (API) used mainly in the treatment of advanced prostate cancer. It works by blocking androgen receptor signalling, which slows the growth of hormone-driven prostate cancer cells. As a well-established oncology molecule (the reference brand is Xtandi), Enzalutamide remains one of the highest-demand prostate cancer APIs worldwide.
Shilpa Pharma is a trusted Enzalutamide API manufacturer and supplier in India, producing this molecule at cGMP-compliant, globally audited facilities. Backed by decades of oncology expertise, Shilpa supports both generic drug developers and innovator companies with reliable, high-purity Enzalutamide API and complete regulatory documentation.
Key specifications
As one of India’s leading oncology API manufacturers, Shilpa combines strong process chemistry, strict quality control, and world-class API manufacturing in India to deliver Enzalutamide that meets the most demanding global standards.
Enzalutamide API is used to manufacture prescription medicines for the treatment of prostate cancer. In clinical practice, Enzalutamide-based drugs are prescribed across several stages of the disease, including non-metastatic and metastatic castration-resistant prostate cancer (nmCRPC and mCRPC) and metastatic castration-sensitive prostate cancer (mCSPC).
The molecule belongs to the androgen receptor signalling inhibitor class. In simple terms, it blocks male hormones (androgens) from attaching to and activating the androgen receptor inside prostate cancer cells. This helps stop tumour growth and, in many cases, extends patient survival.
For formulation, Enzalutamide is most commonly developed as an oral solid dosage form, such as soft capsules or tablets, usually at a 40 mg strength. Because the molecule has low water solubility, formulators often use solubility-enhancing techniques, and Shilpa supplies Enzalutamide API with consistent particle size and solid-state properties to support smooth, reproducible formulation development.
Shilpa supplies Enzalutamide API and related API intermediates to regulated markets (US, EU, Japan, Australia) and emerging markets alike. With integrated CDMO services, the company can also support custom development, scale-up, and long-term commercial supply for prostate cancer drug programs.
Enzalutamide is a potent oncology molecule, so it must be handled with the right safety controls at every stage of manufacturing. Shilpa produces Enzalutamide API under strict containment conditions, using controlled facilities, trained personnel, and protective systems that safeguard both product quality and operator safety. These are the same high standards Shilpa applies as one of the few dedicated HPAPI manufacturers in India.
On product safety, Shilpa places strong focus on impurity control. A nitrosamine and genotoxic impurity (GTI) risk assessment report is available for Enzalutamide, and sensitive analytical methods keep impurities within safe, regulator-approved limits. Every batch is supported by complete quality and stability documentation.
From a clinical reference point, Enzalutamide medicines are prescription-only products. Reported effects in patients can include fatigue, high blood pressure, hot flushes, and musculoskeletal symptoms, and the drug carries specific prescribing precautions. This information is shared only as scientific reference for drug developers and is not medical advice.
Shilpa supplies Enzalutamide API strictly to licensed pharmaceutical manufacturers, biotech firms, and authorised partners, with full regulatory support for safe use in global drug products.
Enzalutamide API pricing is shared on request. Because API cost depends on order volume, delivery timelines, target market, and regulatory requirements, Shilpa provides a customised quotation for every enquiry rather than a fixed list price.
To receive current Enzalutamide API pricing, availability, and documentation (including DMF and technical data), please contact the Shilpa Pharma team. Minimum order quantities apply, and we partner exclusively with pharmaceutical manufacturers, biotech companies, and authorised trading firms.
Email: info@shilpapharma.com | Request a Quote
Choosing the right Enzalutamide API supplier means choosing quality, compliance, and reliability. Here is why global pharmaceutical companies trust Shilpa Pharma:
With decades of proven expertise and world-class API manufacturing in India, Shilpa Pharma is the partner of choice for companies developing safe, effective prostate cancer therapies. Whether you need a single-source Enzalutamide API supplier or a long-term manufacturing partner, Shilpa delivers integrity, quality, and global performance.
Partner with a trusted Enzalutamide manufacturer in India. Contact Shilpa Pharma today.
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Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*
