Androgen Receptor Pathway Inhibitor – Manufacturer and Bulk Supplier in Maharashtra for Prostate Cancer Treatment Formulations
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |
Abiraterone Acetate (CAS 154229-19-3) is the orally bioavailable 3-acetyl prodrug of abiraterone, a potent and selective CYP17A1 inhibitor that blocks androgen biosynthesis in testicular, adrenal, and prostate tumour tissues. Approved as Zytiga® (standard tablets) and Yonsa® (micronised fine particle formulation), it is prescribed with prednisone for metastatic castration-resistant prostate cancer (mCRPC) treatment globally.
Abiraterone Acetate API quality is defined by its polymorphic form stability — Form I is the standard commercial polymorph — acetyl ester integrity (absence of hydrolysis to Abiraterone base >0.5%), and strict control of steroidal process impurities. USP monograph specifies HPLC assay 98.0–102.0%, water content NMT 0.5% (KF), and specific optical rotation +84° to +90°. Micronised grade (D90 <10 µm) is required for fine particle tablet formulations with enhanced bioavailability.
Swapnroop Drugs and Pharmaceuticals manufactures Abiraterone Acetate API at our WHO-GMP Aurangabad facility in both standard and micronised grades. We provide XRPD-confirmed Form I, acetyl ester integrity data, optical rotation confirmation, and validated 24-month ICH stability data in our DMF package — supporting generic manufacturer ANDA filings for the rapidly growing mCRPC generic market.
Abiraterone Acetate API is supplied in food-grade polyethylene-lined fiber drums in 5 kg, 10 kg, and 25 kg net weight options, with desiccant canisters, nitrogen head-space blanket, and oxygen absorbers to prevent acetyl ester hydrolysis. Micronised grade is supplied in additional double-bag containment to prevent particle aggregation.
Get Bulk QuoteThe CAS number for Abiraterone Acetate is 154229-19-3. It is a Androgen Receptor Pathway Inhibitor used in pharmaceutical prostate cancer treatment formulations.
Abiraterone Acetate is classified as a Androgen Receptor Pathway Inhibitor. It is used in prostate cancer treatment formulations and is an established API in both domestic Indian and international pharmaceutical markets.
Abiraterone Acetate API is available in IP, BP, EP, and USP pharmacopeial grades with HPLC purity ≥98.0–102.0%, complete related substances profiling, and residual solvent analysis per ICH Q3C guidelines.
Minimum order is 1 kg for sampling and 25 kg for commercial bulk supply. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility. Larger volumes may be available from existing stock.
Yes, Swapnroop provides complete DMF-grade documentation for Abiraterone Acetate API including Certificate of Analysis (CoA), MSDS, impurity profile, residual solvent certificate, and regulatory filing support for USFDA, EMA, and CDSCO submissions.
Swapnroop Drugs and Pharmaceuticals is a trusted Abiraterone Acetate API manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Abiraterone Acetate API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.
As a Abiraterone Acetate API exporter from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, Certificate of Analysis, MSDS, impurity profiles, and regulatory filing assistance for USFDA, EMA, and CDSCO submissions. Contact us for Abiraterone Acetate API pricing, samples, and sourcing support.