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White Paper

Tech Sheet On Nilotinib Hydrochloride

Tech Sheet on Nilotinib Hydrochloride

Nilotinib is an inhibitor of the BCR-ABL kinase. Nilotinib binds to and stabilizes the inactive conformation of the kinase domain of ABL protein. In vitro, Nilotinib inhibited BCR-ABL-mediated proliferation of murine leukemic cell lines and human cell lines derived from patients with Ph+ chronic myelogenous Leukemia (CML).

Dr. Reddy's is among the earliest generic API manufacturers globally to file the USDMF for Nilotinib HCL API (filed on July 08, 2022), and we are planning to file the EUDMF by March 2022 and we offer monohydrate from-B (Innovator form).

Our manufacturing process has been designed to address customized particle size distribution (PSD) requirements through size reduction and crystallization techniques to consistently meet the most desired PSDs on a commercial scale. With an adequate capacity to meet global demand, we manufacture Nilotinib HCL at our cGMP API manufacturing facility, successfully inspected by international regulatory authorities. In addition, we have de-risked our supply chain as the key starting materials (KSM) of our Nilotinib Hydrochloride API are backward integrated today.

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