Skip to main content


Meet with our product experts in one-on-one virtual sessions

Set Up a Meeting
Quick Connect

Dasatinib (Monohydrate)

Dasatinib (Monohydrate) API

Dasatinib (Monohydrate)-API

CAS Number: 863127-77-9

Therapeutic Category
Anti-Cancer/ Oncology
API Technology
Synthetic
Dose Form
Oral Solids
Dr Reddy's Development Status
Available
Available Regulatory Filing
Japan DMF
Brazil DMF
Korea DMF
Innovator Brand (USA)
Sprycel

Mechanism of Action

Dasatinib, at nanomolar concentrations, inhibits the following kinases: BCR-ABL, SRC family (SRC, LCK, YES, FYN), c-KIT, EPHA2, and PDGFRβ. Based on modeling studies, dasatinib is predicted to bind to multiple conformations of the ABL kinase. In vitro, dasatinib was active in leukemic cell lines representing variants of imatinib mesylatesensitive and resistant disease. Dasatinib inhibited the growth of chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) cell lines overexpressing BCR-ABL. Under the conditions of the assays, dasatinib could overcome imatinib resistance resulting from BCR-ABL kinase domain mutations, activation of alternate signaling pathways involving the SRC family kinases (LYN, HCK), and multi-drug resistance gene overexpression

Indication

SPRYCEL is a kinase inhibitor indicated for the treatment of

  • Newly diagnosed adults with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in chronic phase.
  • Adults with chronic, accelerated, or myeloid or lymphoid blast phase Ph+ CML with resistance or intolerance to prior therapy including imatinib.
  • Adults with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) with resistance or intolerance to prior therapy.
  • Pediatric patients 1 year of age and older with Ph+ CML in chronic phase.
  • Pediatric patients 1 year of age and older with newly diagnosed Ph+ ALL in combination with chemotherapy.

Dr. Reddy's Expertise

Headquartered in Hyderabad, India, Dr. Reddy's Laboratories is one of the leading Active Pharmaceutical Ingredients (API) manufacturers and suppliers globally for Dasatinib (Monohydrate) API. Dr. Reddy's API business is a preferred partner to pharma companies across the US, Europe, Brazil, Latin America, Japan, China, Korea, Middle East and other emerging markets.

Dr. Reddy's API business thrives on the deep technical strengths established over the last 30+ years in the development and manufacture of complex APIs such as steroids, peptides, complex long chain molecules and highly potent APIs (HPAPIs / oncology drugs). This expertise is complemented by our prowess in intellectual property and regulatory affairs which helps us consistently meet and exceed regulatory standards. Dr. Reddy's Dasatinib (Monohydrate) API is the outcome of the extensive expertise in R&D, IP, and Regulatory.

A key component in helping our customers be first to market is a responsive supply chain. We achieve this by making sure that all our facilities are operating efficiently and to the latest standards of quality, safety, and productivity. A strong interconnect between business and factories allows for a quick reaction to dynamic market changes, so that we can avert shortages and meet sudden surges in demand.

Oncology API Products:

Learn More

Contact Us

Please fill in the following form for API Requirement & we'll get back to you shortly

We are here to help, if you have any country specific requirements.

Disclaimer

No information in this catalog - 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, the research quantities of such products may be offered for the purpose of regulatory submissions, wherever such regulatory exemptions exist. The buyers should make their independent evaluation of the patent scenario for their respective markets and will be responsible for all patent related liabilities. Products protected under valid patents in India are not available for commercial use but would be available for Section 107A purposes.

FAQs

24 months Room temperature stability data available on both forms.

Chronic, accelerated, or myeloid or lymphoid blast phase chronic myeloid leukemia; Philadelphia chromosome-positive acute lymphoblastic leukemia.

Take dasatinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. Swallow the tablets whole; do not split, chew, or crush them. Wear latex or nitrile gloves when handling tablets that are accidently crushed or broken to prevent contact with the medication.

Dasatinib belongs to Class 4 of BCS classification

It is available in tablet dosage form with 20, 50, 70, 80, 100, 140 mg strenghts