Abiraterone Acetate

Category
Details
Specifications
CAS Number
154229-18-2
Molecular Formula
C26H33NO2
Molecular Weight
391.55
Synonyms
3β-17-(3-Pyridyl)androsta-5,16-dien-3-ol Acetate
Chemical Name
(3S,8R,9S,10R,13S,14S)-10,13-dimethyl-17-pyridin-3-yl-2,3,4,7,8,9,11,12,14,15-decahydro-1H-cyclopenta[a]phenanthren-3-yl acetate
Grade
USP
Polymorph
Form-A
GTI and NI
Yes
DMF Availability
Yes

Disclaimer: 

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.

Abiraterone Acetate API is a high-potency active pharmaceutical ingredient used in regulated pharmaceutical formulations within the oncology segment. It is supplied exclusively to licensed pharmaceutical manufacturers and qualified pharmaceutical buyers for formulation and development purposes.

The API functions as a selective CYP17 enzyme inhibitor and is a critical component in approved oncology-based therapies. Owing to its quality, consistency, and regulatory compliance profile, Abiraterone Acetate API is widely sourced by pharmaceutical companies operating across regulated and semi-regulated markets.

Shilpa Pharma manufactures Abiraterone Acetate API in GMP-compliant facilities, ensuring suitability for pharmaceutical manufacturing, formulation development, and international supply.

Abiraterone Acetate API is intended strictly for pharmaceutical manufacturing and formulation purposes. It is commonly used in:

  • Oral solid dosage form development, including tablets and capsules
  • Combination product formulations aligned with approved oncology protocols
  • Research and development activities for regulated pharmaceutical products

The API is produced with high purity, controlled particle characteristics, and stable physicochemical properties, supporting consistent performance during formulation development and scale-up. Each batch complies with applicable pharmacopoeial and regulatory standards.

Abiraterone Acetate API is intended exclusively for use by qualified pharmaceutical professionals. Safety considerations related to this API are evaluated during the development, approval, and use of the finished dosage form.

Any effects associated with finished dosage forms containing Abiraterone Acetate are influenced by formulation design, regulatory approvals, and approved clinical usage conditions. Comprehensive quality and safety documentation is provided to support regulatory filings and product development activities.

Final product safety assessment and patient-related considerations remain the responsibility of the finished dosage form manufacturer, in accordance with applicable regulatory guidelines.

Pricing for Abiraterone Acetate API varies based on multiple commercial, technical, and regulatory parameters. As requirements differ across buyers, formulations, and destination markets, pricing is shared on request following a formal enquiry.

Interested buyers are encouraged to submit their technical and regulatory requirements for further discussion.

Shilpa Pharma is a globally trusted API manufacturer and supplier, serving pharmaceutical companies across regulated and semi-regulated markets. Our manufacturing infrastructure, quality systems, and regulatory expertise make us a reliable partner for oncology APIs.

Our Facilities Are:

These certifications reflect our strong compliance framework and global supply capabilities.

Key Advantages:

  • Consistent pharmaceutical-grade purity and quality

  • Reliable supply capabilities for global markets

  • Strong regulatory documentation support

  • Proven expertise in oncology API manufacturing

Partner with Shilpa Pharma for a compliant, reliable, and scalable source of Abiraterone Acetate API.

Why Shilpa Pharma?

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Our Abiraterone Acetate are also Available for

Questions & Answers

FAQ on Abiraterone Acetate

Everything You Need to Know About Shilpa Pharma

Abiraterone Acetate API is an active pharmaceutical ingredient used in the manufacture of formulations for the treatment of metastatic castration-resistant prostate cancer (mCRPC). It works by inhibiting androgen biosynthesis, helping to slow disease progression.
Yes. Abiraterone Acetate API manufactured by Shilpa Pharma is produced in GMP-compliant facilities and is suitable for regulated and semi-regulated markets, subject to customer-specific regulatory requirements.
Shilpa Pharma follows ICH guidelines, GMP standards, and strict internal quality control protocols. Each batch undergoes comprehensive testing to ensure purity, potency, stability, and consistency.
Shilpa Pharma can provide standard B2B documentation, including: Certificate of Analysis (CoA), Material Safety Data Sheet (MSDS) ,GMP Certificate , Stability data (on request) , Regulatory support documents (as applicable)
The API is supplied in secure, pharma-grade packaging designed to maintain product integrity during storage and international transportation. Custom packaging options may be available based on order quantity and regulatory needs.
Abiraterone Acetate API typically has a long shelf life under recommended storage conditions, as mentioned in the CoA and stability data provided with each batch.
Yes. Shilpa Pharma supports bulk supply, long-term contracts, and customized requirements for pharmaceutical manufacturers, exporters, and formulation companies worldwide.
Batch-to-batch consistency is ensured through validated manufacturing processes, strict in-process controls, and robust quality assurance systems, ensuring reliable performance in finished dosage formulations.
Yes. Shilpa Pharma provides technical and regulatory support to assist partners during product development, scale-up, and regulatory submissions, depending on project scope.
B2B buyers can contact Shilpa Pharma through official business channels to request pricing, technical details, documentation, and lead times. All inquiries are handled with confidentiality and compliance.

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