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Tech Sheet on Ibrutinib

Ibrutinib API

Ibrutinib is a small-molecule inhibitor of Bruton's tyrosine kinase (BTK). Nonclinical studies show that ibrutinib can inhibit malignant B-cell proliferation and survival in vivo and cell migration and substrate adhesion in vitro.

With a CAGR of 26.1% from 2020-2030, the global Ibrutinib market is projected to reach USD 66.28 billion by 2030. Imbruvica's® (Ibrutinib) market growth is driven by the emergence of new cancer therapies and the growing approval of targeted therapies. During the forecast period, Chronic lymphocytic leukemia (CLL) will have the highest CAGR of 27.3%, outpacing other applications [3]. Moreover, the Ibrutinib market is expected to flourish due to increased R&D, clinical trials, and usage approvals by regulatory authorities.

Dr. Reddy's API Offering

  • We offer Ibrutinib Form – A, i.e., Innovator form.
  • The control strategy for the API impurity profile has been designed through quality-by-design (QbD) based development.

We manufacture Ibrutinib API at our cGMP API manufacturing facility, which was successfully inspected by international regulatory authorities - TGA, WHO GMP, KFDA, PMDA, Health Canada, ANVISA, and USFDA. We have reliable Key Starting Material (KSM) suppliers to ensure timely deliveries and adherence to stringent specifications. Advanced intermediates are manufactured at qualified strategic partner sites and can be scaled-up to meet commercial requirements.

To know more about our API offerings, please read the Tech sheet on Ibrutinib API by filling 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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