About Dasatinib (Monohydrate) API

Therapeutic Category抗癌/抗肿瘤
API Technology
Synthetic
Dose Form
Oral Solid/Tablets
Dr Reddy's Development Status
Available (Commercial)
Available Regulatory Filing
USDMF, Brazil DMF, EUDMF, Canada DMF, Korea DMF, Taiwan DMF
作用机制
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
适应症
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的专长
Dr. Reddy's总部位于印度海得拉巴,是全球领先的活性药物成分(API)供应商之一。 Dr. Reddy's的API业务是美国、欧洲、巴西、拉丁美洲、日本、中国、韩国和新兴市场的制药公司的首选合作伙伴。
Dr. Reddy's博士的API业务在过去30多年来在开发和制造复杂API(如类固醇,多肽,复杂长链分子和高效API(HPAPI /肿瘤药物))方面所建立的深厚技术优势中茁壮成长。 我们在知识产权和法规事务方面的实力可以帮助我们始终如一地达到并超越监管标准,从而为这一专业知识提供补充。 Dr. Reddy's博士 达沙替尼一水 合物 API是研发,知识产权和监管方面广泛专业知识的结果。
帮助我们的客户率先进入市场的关键组成部分是响应式供应链。 我们通过确保所有设施都高效运行并达到最新的质量,安全和生产率标准来实现这一目标。 业务和工厂之间的强大互联可以快速响应动态的市场变化,从而避免短缺并满足需求的突然激增。
RFQ Form
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