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White Paper

Substantially Pure Carfilzomib Amorphous for Generic Launch

Substantially Pure Carfilzomib Amorphous for Generic Launch

Kyprolis (carfilzomib) is a proteasome inhibitor that irreversibly binds to the N-terminal threonine-containing active sites of the 20S proteasome, the proteolytic core particle within the 26S proteasome. Carfilzomib had antiproliferative and proapoptotic activities in vitro in solid and hematologic tumour cells. In animals, carfilzomib inhibited proteasome activity in blood and tissue and delayed tumour growth.

Dr. Reddy's API Offering

Dr. Reddy’s Carfilzomib API is a notable example of the technical capabilities of product development. It offers our customers access to a generic API that shows distinct features of having optimal consumption co-efficient in line with the green chemistry concept and superlative quality resulting from a robust process at scale.

  • We manufacture Carfilzomib amorphous API at our cGMP API manufacturing facility, successfully inspected by international regulatory authorities - USFDA, KFDA, WHO- GMP, Russian Federation, and ANVISA (document-based inspection completed and certificate is available).
  • To achieve high supply assurance, our key starting materials (KSM) are sourced domestically, and one is from China.
  • Continuous improvement is in place to achieve quality and supply excellence.
  • The current batch size is about 1.5 kg (Per customer requirement, discrete lots can be supplied).

To learn more about our API offerings, please read the product alert Carfilzomib API by filling out the contact form below.

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Disclaimer

No information on this website, 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, in certain cases, at Dr. Reddy's sole discretion, and subject to local legal requirement, the research quantities of such products may be offered for the purpose of regulatory submissions under Section 107A of the Indian Patent Act (Bolar exemption), wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the product or service including, patent scenario in their respective markets and will be responsible for all patent related liabilities Dr. Reddy's disclaims all warranties, express or implied, including but not limited to warranties of merchantability, fitness for a particular purpose and non-infringement.

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Dr. Reddy’s Laboratories, 8-2-337,
Banjara Hills Rd Number 3,
SBI Executive Enclave, Green Valley,
Banjara Hills, Hyderabad,
Telangana 500034
Phone: 040 4900 2222

© 2025 Dr. Reddy’s Laboratories Ltd. All rights reserved.

Dr. Reddy’s Laboratories, 8-2-337,
Banjara Hills Rd Number 3,
SBI Executive Enclave, Green Valley,
Banjara Hills, Hyderabad,
Telangana 500034
Phone: 040 4900 2222

  • Twitter

© 2025 Dr. Reddy’s Laboratories Ltd.
All rights reserved.

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