Compare qualified Clofarabine API suppliers worldwide. We currently have 9 companies offering Clofarabine API, with manufacturing taking place in 3 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
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CDMO
Produced in Asia
Employees: 5000+
Audit Report: Available
Certifications: CoA, GMP
See all 7 certificates
Employees: 25
See all 6 certificates
Produced in Europe
Certifications: CoA
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A medication that treats relapsed or refractory pediatric acute lymphoblastic leukemia, offering targeted antineoplastic benefits with critical importance on quality and supply consistency.
Adenine Nucleotides Antimetabolites Antineoplastic Agents Antineoplastic and Immunomodulating Agents Arabinonucleosides BCRP/ABCG2 Substrates
Clofarabine (CAS number 123318-82-1) is a purine nucleoside antimetabolite indicated for the treatment of pediatric patients aged 1 to 21 years with relapsed or refractory acute lymphoblastic leukemia (ALL) after at least two prior treatment regimens have failed. It has received orphan drug designation by the US Food and Drug Administration for this indication. The compound is marketed under the brand names Clolar in the United States and Canada, and Evoltra in Europe, Australia, and New Zealand. Investigational uses include acute myeloid leukemia (AML) and juvenile myelomonocytic leukemia (JMML).
Pharmacologically, clofarabine is classified as a purine 2'-deoxyribonucleoside analogue, distinguished by the presence of chlorine on the purine ring and fluorine in the ribose moiety. Its cytotoxic activity arises from inhibition of nucleic acid synthesis, ultimately interfering with DNA and RNA replication required for cancer cell proliferation.
Mechanistically, clofarabine undergoes intracellular phosphorylation to its active 5'-triphosphate metabolite via deoxycytidine kinase followed by additional kinase-mediated phosphorylation steps. The active metabolite inhibits ribonucleotide reductase and competitively blocks DNA polymerases, resulting in depletion of deoxynucleotide triphosphates and termination of DNA chain elongation. Additionally, it impairs DNA repair by incorporation into DNA strands and disrupts mitochondrial membrane integrity, triggering release of pro-apoptotic factors such as cytochrome C and apoptosis-inducing factor. These mechanisms cumulatively induce programmed cell death in malignant cells.
Key ADME considerations include primary renal excretion and intracellular activation by nucleoside kinases. Clofarabine exhibits a narrow therapeutic index, necessitating careful dose management to mitigate toxicities such as myelosuppression and immunosuppression. Safety monitoring is emphasized due to risks of hematologic adverse effects and potential off-target impacts on normal proliferating cells.
From a procurement perspective, assurance of API quality through compliance with stringent regulatory standards and reliable supply chain management is critical. The drug’s narrow therapeutic index and complex metabolism highlight the importance of sourcing clofarabine with verified purity, consistent potency, and validated impurity profiles to support safe and effective pharmaceutical product formulation.
Antineoplastics are a crucial category of pharmaceutical active pharmaceutical ingredients (APIs) primarily used in the treatment of cancer. These powerful substances inhibit or destroy the growth of cancer cells, thus impeding the progression of malignancies.
Antineoplastics exert their therapeutic effects through various mechanisms. Some APIs interfere with DNA replication, inhibiting the division and proliferation of cancer cells. Others target specific proteins or enzymes involved in tumor growth, effectively blocking their function. Additionally, certain antineoplastic agents induce programmed cell death, known as apoptosis, in cancer cells.
These APIs find application in a wide range of cancer treatments, including chemotherapy, targeted therapy, immunotherapy, and hormone therapy. They are often administered in combination with other drugs to optimize therapeutic outcomes and minimize drug resistance.
Antineoplastics are typically synthesized through complex chemical processes, ensuring high purity and potency. Stringent quality control measures are implemented throughout manufacturing to meet regulatory standards and ensure patient safety.
Although antineoplastics offer significant benefits in treating cancer, they can also cause adverse effects due to their cytotoxic nature. Common side effects include bone marrow suppression, gastrointestinal disturbances, hair loss, and immune system suppression. Close monitoring and supportive care are essential to manage these side effects effectively.
In conclusion, antineoplastics are a vital category of pharmaceutical APIs used in the treatment of cancer. Through their diverse mechanisms of action, these compounds play a critical role in combating malignancies and improving patient outcomes.
