Abiraterone Acetate API
CAS Number: 154229-18-2
About Abiraterone Acetate API
Therapeutic Category
Anti-Cancer/ Oncology
API Technology
Steroid
Dose Form
Oral Solids
Dr Reddy's Development Status
Available
Available Regulatory Filing
USDMF
Mechanism of Action
Abiraterone is an orally active inhibitor of the steroidal enzyme CYP17A1 (17 alpha-hydroxylase/C17,20 lyase). It inhibits CYP17A1 in a selective and irreversible manner via covalent binding mechanism.
Indication
ZYTIGA is a CYP17 inhibitor indicated in combination with prednisone for the treatment of patients with
- Metastatic castration-resistant prostate cancer (CRPC).
- Metastatic high-risk castration-sensitive prostate cancer (CSPC)
Dr. Reddy's Expertise
Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Abiraterone Acetate API. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.
Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Abiraterone Acetate API is the outcome of the extensive expertise in R&D, IP, and Regulatory.
A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.
Get access to reliable and cost-effective abiraterone acetate API from Dr. Reddy's. As a leading manufacturer, we prioritize quality and affordability. To know more about Abiraterone Acetate price please contact us at api@drreddys.com
Related Resources
Tech Sheet: Dr. Reddy’s Abiraterone Acetate API offerings
Abiraterone is an orally active inhibitor of the steroidal enzyme CYP17A1 (17 alpha-hydroxylase/C17,20 lyase). It inhibits CYP17A1 selectively and irreversibly via a covalent binding mechanism. Abiraterone is a CYP17 inhibitor indicated in combination with prednisolone to treat patients with metastatic castration-resistant prostate cancer (CRPC) and Metastatic high-risk castration-sensitive prostate cancer (CSPC).
Abiraterone Acetate (Zytiga, Janssen Biotech Inc.) was approved by the Food and Drug Administration (FDA) on April 28, 2011, for Prostate Cancer treatment. In December 2012, FDA expanded Zytiga’s use for late-stage Prostate Cancer. In February 2018, the FDA approved Abiraterone Acetate tablets with prednisone for metastatic high-risk castration sensitive prostate cancer (CSPC).
As of February 2008, Abiraterone is approved in various countries worldwide for different indications.
Key takeaways of Dr. Reddy’s Abiraterone Acetate API:
- Enough capacity to cater to current market requirements.
- Quality – in line with ICH guidelines.
- Earliest generic API manufacturer of abiraterone globally.
- Country-specific regulatory filings
- GTI & Nitrosamine free.
To know more about our offerings , please read the technical sheet on Abiraterone Acetate by filling the contact form below.
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Disclaimer
No information in this catalog - including any reference to any product or service - constitutes an offer for sale, or be construed as representing an offer for sale. Products protected under valid patents are not offered or supplied for commercial use. However, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.
FAQs
It belongs to Anti-neoplastic drug class
It is a oncology product used to treat Metastatic castration-resistant prostate cancer (CRPC). Metastatic high-risk castration-sensitive prostate cancer (CSPC)
Abiraterone is available in 250 mg and 500 mg dosage forms
We offer polymorph Form-A for Abiraterone API
Meet with our product experts in one-on-one virtual sessions at https://api.drreddys.com/meet-api-experts or Write to us at api@drreddys.com.
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