Azacitidine API
CAS Number: 320-67-2
About Azacitidine API
Therapeutic Category
Anti-Cancer/ Oncology
API Technology
High Potent
Dose Form
Injectable
Dr Reddy's Development Status
Available
Available Regulatory Filing
USDMF
Mechanism of Action
VIDAZA is a pyrimidine nucleoside analog of cytidine. VIDAZA is believed to exert its antineoplastic effects by causing hypomethylation of DNA and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow. The concentration of azacitidine required for maximum inhibition of DNA methylation in vitro does not cause major suppression of DNA synthesis. Hypomethylation may restore normal function to genes that are critical for differentiation and proliferation. The cytotoxic effects of azacitidine cause the death of rapidly dividing cells, including cancer cells that are no longer responsive to normal growth control mechanisms. Non-proliferating cells are relatively insensitive to azacitidine.
Indication
VIDAZA is a nucleoside metabolic inhibitor indicated for the treatment of patients with the following FAB myelodysplastic syndrome (MDS) subtypes: Refractory anemia (RA) or refractory anemia with ringed sideroblasts (RARS) (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL).
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 Azacitidine 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 Azacitidine 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.
Related Resources
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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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
It is available in powder (Intra venous/Subcutaneous) form and we offer polymorph form 1
Store at tightly closed container at a temperature below 25°C (excursions allowed between 15 and 30°C
Azacitidine is used to treat patients with French-American-British (FAB) myelodysplastic syndrome (bone marrow problem) subtypes, including refractory anemia or chronic leukemia. This medicine is also used to treat juvenile myelomonocytic leukemia (JMML).
Azacitidine belongs to Class 3 of BCS classification
Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin. Be careful when using a regular toothbrush, dental floss, or toothpick.
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