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Tech Sheet - Dr. Reddy’s Azacitidine API offerings

Azacitidine is a nucleoside metabolic inhibitor indicated to continue treating adult patients with acute myeloid leukemia. In addition, it is indicated for use in adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy.

FDA approved the original dosage form, i.e., Vidaza (Injectable), to treat myelodysplastic syndrome (MDS) and new oral dosage form, i.e., Onureg® (Azacitidine tablets) as a continued treatment for adults in the first remission with acute myeloid leukemia [3].

The annual sales of the innovator oral formulation for the four quarters ending September 2021 is ~ $ 51 million [4], almost entirely from sales in the US. Analyst reports estimate peak sales forecasts for Onureg® at ~ $730 million to $1.5 billion after the US approval.

To know more about our API offerings, please read the technical sheet on Azacitidine by filling the contact from below.

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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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