Tech Sheet on Ibrutinib
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.
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