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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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免责声明

本目錄中的任何信息(包括對任何產品或服務的任何引用)均不構成銷售要約,或被解釋為代表銷售要約。受有效專利保護的產品不提供或供應用於商業用途。但是,只要存在此類監管豁免,就可以出於監管提交的目的提供此類產品的研究數量。買方應對各自市場的專利方案進行獨立評估,並承擔所有與專利相關的責任。在印度受有效專利保護的產品不可用於商業用途,但可用於第 107A 節。

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