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Cyclophosphamide | CAS No: 50-18-0 | GMP-certified suppliers
A medication that treats multiple malignancies and pediatric nephrotic syndrome by inhibiting cell proliferation through alkylating DNA, requiring careful quality control for safe clinical use.
Therapeutic categories
Primary indications
- Cyclophosphamide is indicated for the treatment of malignant lymphomas, multiple myeloma, leukemias, mycosis fungoides (advanced disease), neuroblastoma (disseminated disease), adenocarcinoma of the ovary, retinoblastoma, and carcinoma of the breast
- It is also indicated for the treatment of biopsy-proven minimal change nephrotic syndrome in pediatric patients
Product Snapshot
- Cyclophosphamide is available primarily as injectable solutions and lyophilized powder for injection, with oral tablet formulations also available
- It is used mainly in oncology for treating malignant lymphomas, multiple myeloma, leukemias, various solid tumors, and certain pediatric nephrotic syndromes
- Cyclophosphamide is approved for use in major regulatory markets, including the US and Canada
Clinical Overview
Clinically, cyclophosphamide is indicated for the treatment of multiple malignancies, including malignant lymphomas, leukemias, multiple myeloma, advanced mycosis fungoides, disseminated neuroblastoma, ovarian adenocarcinoma, retinoblastoma, and breast carcinoma. Additionally, it is used in pediatric patients to treat biopsy-confirmed minimal change nephrotic syndrome.
Pharmacodynamically, cyclophosphamide belongs to the class of alkylating agents that disrupt DNA function through multiple mechanisms. These include the attachment of alkyl groups to DNA bases leading to strand breaks during attempted repair, the formation of DNA cross-links that prevent strand separation necessary for replication and transcription, and the induction of nucleotide mispairing resulting in mutations. These effects culminate in inhibition of cell proliferation and induction of apoptosis. The agent is cell cycle-nonspecific.
Key absorption, distribution, metabolism, and excretion (ADME) characteristics involve activation by liver cytochrome P450 enzymes (notably CYP2B6, CYP3A4, and others), with a narrow therapeutic index due to variable metabolism and significant toxicity risk. Cyclophosphamide’s metabolism is complex, involving multiple CYP isoenzymes, which may be induced or inhibited by concomitant medications, influencing efficacy and safety.
Safety considerations include risks of myelosuppression, cardiotoxicity, immunosuppression, and secondary malignancies. Notable toxicities are alopecia, sterility, teratogenicity, mutagenicity, and potential carcinogenicity. These effects necessitate careful monitoring of hematologic parameters and avoidance in pregnancy when possible.
Cyclophosphamide has been commercialized under various brand names globally and remains a key component in combination chemotherapy regimens and certain immunosuppressive protocols.
For API procurement, stringent quality control is critical, focusing on purity, residual solvents, and consistent impurity profiles due to the narrow therapeutic index and complex metabolism. Suppliers should comply with current Good Manufacturing Practices (cGMP) and provide comprehensive regulatory documentation to support clinical use and regulatory submissions.
Identification & chemistry
| Generic name | Cyclophosphamide |
|---|---|
| Molecule type | Small molecule |
| CAS | 50-18-0 |
| UNII | 6UXW23996M |
| DrugBank ID | DB00531 |
Pharmacology
| Summary | Cyclophosphamide is an alkylating agent that exerts antineoplastic effects by covalently binding to DNA, causing cross-linking and alkylation of DNA bases. These interactions disrupt DNA replication and transcription, leading to impaired cell division and apoptosis. Its mechanism is cell cycle-nonspecific and targets DNA to induce cytotoxicity in malignant and proliferative disease states. |
|---|---|
| Mechanism of action | Alkylating agents work by three different mechanisms: 1) attachment of alkyl groups to DNA bases, resulting in the DNA being fragmented by repair enzymes in their attempts to replace the alkylated bases, preventing DNA synthesis and RNA transcription from the affected DNA, 2) DNA damage via the formation of cross-links (bonds between atoms in the DNA) which prevents DNA from being separated for synthesis or transcription, and 3) the induction of mispairing of the nucleotides leading to mutations. |
| Pharmacodynamics | Cyclophosphamide is an antineoplastic in the class of alkylating agents and is used to treat various forms of cancer. Alkylating agents are so named because of their ability to add alkyl groups to many electronegative groups under conditions present in cells. They stop tumor growth by cross-linking guanine bases in DNA double-helix strands - directly attacking DNA. This makes the strands unable to uncoil and separate. As this is necessary in DNA replication, the cells can no longer divide. In addition, these drugs add methyl or other alkyl groups onto molecules where they do not belong which in turn inhibits their correct utilization by base pairing and causes a miscoding of DNA. Alkylating agents are cell cycle-nonspecific. Alkylating agents work by three different mechanisms all of which achieve the same end result - disruption of DNA function and cell death. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA | Humans | cross-linking/alkylation |
| Nuclear receptor subfamily 1 group I member 2 | Humans |
ADME / PK
| Absorption | After oral administration, peak concentrations occur at one hour. |
|---|---|
| Half-life | 3-12 hours |
| Protein binding | 20% of cyclophosphamide is protein bound with no dose dependent changes. Some metabolites are protein bound to an extent greater than 60%. |
| Metabolism | Metabolism and activation occurs at the liver. 75% of the drug is activated by cytochrome P450 isoforms, CYP2A6, 2B6, 3A4, 3A5, 2C9, 2C18, and 2C19. The CYP2B6 isoform is the enzyme with the highest 4-hydroxylase activity. Cyclophosphamide undergoes activation to eventually form active metabolites, phosphoramide mustard and acrolein. Cyclophosphamide appears to induce its own metabolism which results in an overall increase in clearance, increased formation of 4-hydroxyl metabolites, and shortened t1/2 values following repeated administration. |
| Route of elimination | Cyclophosphamide is eliminated primarily in the form of metabolites. 10-20% is excreted unchanged in the urine and 4% is excreted in the bile following IV administration. |
| Volume of distribution | 30-50 L |
| Clearance | Total body clearance = 63 ± 7.6 L/kg. |
Formulation & handling
- Cyclophosphamide is a small molecule nitrogen mustard compound available in both oral and parenteral forms, primarily intravenous injection. The API exhibits moderate water solubility facilitating formulation in aqueous injection solutions and lyophilized powders for reconstitution. Oral formulations should consider administration with food to reduce gastrointestinal irritation and ensure adequate hydration during therapy.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is currently under patent protection in the United States with key patents expiring between mid-2035 and early 2036. The product is marketed in the US and Canada, representing a market with ongoing patent exclusivity and limited generic competition. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Cyclophosphamide is manufactured and packaged by multiple originator and generic companies with presence primarily in the US and Canadian markets. Several patents related to this drug extend until 2035-2036, indicating ongoing patent protection and limited generic competition at present. The branded product maintains a strong presence in North America with no indication of widespread global branded distribution beyond these regions. |
|---|
Safety
| Toxicity | Adverse reactions reported most often include neutropenia, febrile neutropenia, fever, alopecia, nausea, vomiting, and diarrhea. |
|---|
- Handle with appropriate protective equipment to minimize exposure due to risk of myelosuppression including neutropenia
- Avoid inhalation and skin contact, as cyclophosphamide can cause systemic toxicity
- Observe proper containment measures to reduce risk of adverse effects such as gastrointestinal toxicity and alopecia in manufacturing environments
Cyclophosphamide is a type of Alkylating agents
Alkylating agents are a vital subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a significant role in cancer treatment. These compounds possess the ability to attach alkyl groups to the DNA molecule, effectively disrupting its structure and preventing cell replication. This mechanism of action makes alkylating agents potent chemotherapy drugs for various types of cancers.
Alkylating agents are often classified based on their chemical structure, which includes nitrogen mustards, ethylenimines, nitrosoureas, and alkyl sulfonates, among others. Each subclass exhibits unique chemical properties and therapeutic applications. For instance, nitrogen mustards like cyclophosphamide and mechlorethamine are used to treat lymphomas and leukemia, while nitrosoureas such as carmustine and lomustine are effective against brain tumors.
The alkylating agents' mode of action involves the transfer of alkyl groups to cellular components, primarily DNA. This leads to the formation of DNA adducts, cross-links, and DNA strand breaks, ultimately hindering DNA replication and causing cell death. The indiscriminate nature of alkylating agents can also affect healthy cells, leading to various side effects such as bone marrow suppression and gastrointestinal disturbances.
Despite their potential side effects, alkylating agents remain valuable tools in cancer therapy due to their broad spectrum of activity against different types of tumors. Ongoing research focuses on developing more selective and targeted alkylating agents to improve their therapeutic index and minimize adverse effects. The use of alkylating agents in combination with other chemotherapy drugs or radiation therapy is also being explored to enhance treatment outcomes and reduce drug resistance.
In conclusion, alkylating agents are an essential subclass of pharmaceutical APIs widely employed in cancer treatment. Their ability to disrupt DNA structure and impede cell replication makes them effective against various types of tumors, although careful management of side effects is necessary. Ongoing advancements and research continue to refine their therapeutic potential in the fight against cancer.
Cyclophosphamide (Alkylating agents), classified under Anticancer drugs
Anticancer drugs belong to the pharmaceutical API (Active Pharmaceutical Ingredient) category designed specifically to combat cancer cells. These powerful medications play a crucial role in cancer treatment and are developed to target and destroy cancerous cells, preventing their growth and spread.
Anticancer drugs are classified based on their mode of action and can include various types such as chemotherapy drugs, targeted therapy drugs, immunotherapy drugs, and hormonal therapy drugs. Chemotherapy drugs work by interfering with the cell division process, thereby inhibiting the growth of cancer cells. Targeted therapy drugs, on the other hand, are designed to attack specific molecules or genes involved in cancer growth, minimizing damage to healthy cells. Immunotherapy drugs stimulate the body's immune system to recognize and destroy cancer cells. Hormonal therapy drugs are used in cancers that are hormone-dependent, such as breast or prostate cancer, to block the hormones that fuel cancer cell growth.
These APIs are typically synthesized through complex chemical processes in state-of-the-art manufacturing facilities. Stringent quality control measures ensure the purity, potency, and safety of these drugs. Anticancer APIs undergo rigorous testing and adhere to stringent regulatory guidelines before being approved for clinical use.
Due to their critical role in cancer treatment, anticancer drugs are in high demand worldwide. Researchers and pharmaceutical companies continually strive to develop new and more effective APIs in this category to enhance treatment outcomes and minimize side effects. The ongoing advancements in the field of anticancer drug development offer hope for improved cancer therapies and better patient outcomes.
Cyclophosphamide API manufacturers & distributors
Compare qualified Cyclophosphamide API suppliers worldwide. We currently have 10 companies offering Cyclophosphamide API, with manufacturing taking place in 4 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Ampac Fine Chemicals | Producer | United States | United States | CoA, USDMF | 6 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF | 176 products |
| Emcure Pharma | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 80 products |
| Hetero Labs | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 90 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| MSN Labs. | Producer | India | India | CoA, USDMF | 119 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shandong Boyuan | Producer | China | China | BSE/TSE, CoA, MSDS | 55 products |
| Shilpa Medicare Ltd | Producer | India | India | BSE/TSE, CoA, GMP, ISO9001, MSDS, USDMF, WC | 54 products |
| Zhejiang Hisun Pharma | Producer | China | China | CoA, USDMF | 69 products |
When sending a request, specify which Cyclophosphamide API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
Use the list above to find high-quality Cyclophosphamide API suppliers. For example, you can select GMP, FDA or ISO certified suppliers. Visit our help page to learn more about sourcing APIs via Pharmaoffer.
