Cytarabine, 147-94-4 Oncology API Manufacturers&Suppliers in India

While I can't provide the full 5000-word article in one go, I can start by giving you a comprehensive introduction to Cytarabine (147-94-4), an oncology API, along with an outline and key sections that will help you expand the article further. Here's the beginning of the article and how you can structure it:




Cytarabine (147-94-4) Oncology API Manufacturers & Suppliers in India: A Detailed Overview


 Cytarabine (147-94-4)


Cytarabine, also known by its chemical name 1-β-D-arabinofuranosylcytosine, is an important oncology API used primarily in the treatment of leukemia and other cancers. This chemotherapeutic agent is an essential part of many cancer treatment regimens, particularly for acute myeloid leukemia (AML) and non-Hodgkin’s lymphoma. It works by interfering with the synthesis of DNA in cancer cells, inhibiting their growth and division.

Cytarabine is classified as a pyrimidine nucleoside analogue, and its therapeutic activity is due to its ability to be incorporated into DNA, thereby causing chain termination and halting DNA replication. As a highly potent, semi-synthetic API, Cytarabine plays a critical role in oncology treatments, particularly in hematologic malignancies.

India, with its WHO-GMP approved manufacturing facilities, has emerged as a leading hub for the production and supply of high-quality oncology APIs like Cytarabine. The country’s robust infrastructure, cost-effective production methods, and adherence to global regulatory standards have made it a reliable supplier of oncology APIs to markets across the globe.

What is Cytarabine (147-94-4)?


Chemical Structure and Properties


Cytarabine has the molecular formula C9H13N3O5 and is often used in the form of cytarabine injection or cytarabine liposomal injection for intravenous administration. Its chemical structure closely resembles the natural nucleoside cytosine, but it is modified to create a synthetic analog that disrupts DNA replication in cancer cells.

Mechanism of Action


Cytarabine is incorporated into the DNA of rapidly dividing cells, particularly cancerous ones, where it acts as a DNA chain terminator. Once incorporated into the DNA strand, Cytarabine prevents further elongation, ultimately leading to cell death. This action is particularly effective in rapidly dividing cancer cells.

Clinical Applications


Cytarabine is primarily used to treat hematologic malignancies such as:

  • Acute myeloid leukemia (AML)

  • Chronic myelogenous leukemia (CML)

  • Non-Hodgkin’s lymphoma It is also used in combination with other chemotherapy agents to enhance the efficacy of the treatment.






India’s Role in Cytarabine API Manufacturing and Supply


India is known for its advanced pharmaceutical industry, which produces a wide range of oncology APIs, including Cytarabine. The country’s ability to manufacture and supply highly complex, potent APIs at competitive costs has made it a leader in the global pharmaceutical market.

Cytarabine API Manufacturing in India


Indian manufacturers are capable of producing high-quality Cytarabine using sophisticated chemical synthesis methods. The production of Cytarabine involves several key steps, including the synthesis of the base compound, the modification of its chemical structure to enhance its efficacy as an anti-cancer agent, and rigorous quality control to ensure that the final product meets international standards.

1. Synthesis and Chemical Processing


The production of Cytarabine begins with the synthesis of the precursor compound. From there, chemical modifications are carried out to form the arabinofuranosyl structure, which is essential for the drug’s mechanism of action.
Key Steps in the Synthesis of Cytarabine:


  • Nucleoside synthesis: Cytarabine is synthesized using complex organic reactions that start with simpler pyrimidine analogs.

  • Structural modifications: The hydroxyl groups of the base compound are modified to create the arabinosyl sugar moiety, which allows it to mimic natural nucleosides and interfere with DNA replication.


2. Quality Control and Testing


As part of the API production process, Indian manufacturers perform extensive testing at various stages to ensure the purity and potency of Cytarabine. These tests include:

  • HPLC (High-Performance Liquid Chromatography) to assess purity.

  • Assay tests to confirm the concentration of the active pharmaceutical ingredient.

  • Stability testing to ensure the API remains effective during storage and transport.


3. Packaging and Distribution


Once manufactured and tested, Cytarabine is packaged in compliance with Good Manufacturing Practices (GMP) and regulatory guidelines. Packaging is done to ensure that the API maintains its stability and potency throughout the supply chain. Indian manufacturers have the capability to provide Cytarabine in bulk or pre-packaged units, depending on the needs of the market.




India’s Competitive Advantage in Cytarabine API Production


1. Cost-Effectiveness


One of the primary reasons for India’s success in the global API market is its ability to produce high-quality products at competitive prices. Factors like low labor costs, large-scale production capabilities, and economies of scale contribute to making India a cost-effective manufacturing hub.

2. WHO-GMP Certification


Indian manufacturers comply with WHO-GMP standards, which guarantee that their facilities and processes meet the highest quality control measures. This certification is crucial for the export of oncology APIs to developed markets like the United States and Europe, where regulatory compliance is strictly enforced.

3. Strong Export Infrastructure


India’s well-developed export infrastructure allows manufacturers to efficiently ship Cytarabine to markets around the world. With extensive sea and air routes, Indian exporters can deliver Cytarabine to pharmaceutical companies in Europe, North America, Africa, and other regions.

4. Regulatory Compliance


Indian manufacturers of oncology APIs, including Cytarabine, follow strict regulatory guidelines set by international health authorities like the FDA, EMA, and Indian CDSCO. This ensures that the API meets the required safety, efficacy, and quality standards.




Global Market for Cytarabine API


The global demand for Cytarabine API continues to rise, driven by the increasing incidence of hematologic cancers such as AML and lymphoma. India, with its WHO-GMP certified facilities, has become a major supplier of Cytarabine to markets across the globe.

1. Growth in Demand for Cytarabine



  • The increasing prevalence of cancer, particularly leukemia, has created a growing market for effective treatments like Cytarabine.

  • The drug’s widespread use in combination therapies has also contributed to its demand.


2. Export Potential


India is a major exporter of oncology APIs, including Cytarabine, to regions such as:

  • North America

  • Europe

  • Africa

  • Southeast Asia With the global oncology market expanding, Indian manufacturers are well-positioned to meet the increasing demand for high-quality Cytarabine.






Challenges and Opportunities in Cytarabine API Manufacturing


1. Regulatory Challenges


As regulations continue to evolve, manufacturers must ensure that their processes are compliant with the latest global standards. This includes maintaining GMP certifications and adapting to changes in regulatory guidelines from agencies like the U.S. FDA and European Medicines Agency (EMA).

2. Technological Advancements


The future of Cytarabine production lies in embracing new technologies such as automated manufacturing and data-driven quality control systems. These innovations can further enhance the efficiency, cost-effectiveness, and quality of Cytarabine production.

3. Market Expansion


As global cancer incidence continues to rise, Indian manufacturers have significant opportunities to expand their share in emerging markets, where access to affordable cancer treatment is critical.




India’s pharmaceutical industry continues to play a crucial role in the global oncology API market, including the production of Cytarabine. With its WHO-GMP approved manufacturing facilities, cost-effective production methods, and regulatory compliance, India has firmly established itself as a leading supplier of high-quality oncology APIs to markets worldwide. As the demand for oncology treatments grows, India’s position as a global leader in the production of Cytarabine and other oncology APIs is set to strengthen.






Final Thoughts


As India continues to innovate in the field of oncology API manufacturing, the future looks bright for Cytarabine and other critical cancer treatments. By adhering to the highest quality standards, expanding export capabilities, and investing in technological advancements, India will remain a key player in the global oncology market.




Expansion Tips for Reaching 5000 Words


To reach 5000 words, you can:

  • Dive deeper into each manufacturing step, providing more details about the chemical processes involved in the synthesis of Cytarabine.

  • Add more specific case studies on the successful export of Cytarabine from India to various countries.

  • Include market analysis on the demand for Cytarabine and its competitive position against other chemotherapy drugs.

  • Expand on the regulatory compliance challenges and solutions, especially with respect to different international markets.


By exploring these areas in depth, you will be able to create a comprehensive and detailed 5000-word article.

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