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Diaminocyclohexane oxalatoplatinum (Oxaliplatin) API Manufacturers & Suppliers
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Oxaliplatin | CAS No: 61825-94-3 | GMP-certified suppliers
A medication that supports treatment of advanced colorectal cancer and adjuvant management of stage III colon cancer when used in established combination chemotherapy regimens.
Therapeutic categories
Primary indications
- Oxaliplatin, in combination with infusional fluorouracil and leucovorin, is indicated for the treatment of advanced colorectal cancer and adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor
Product Snapshot
- Oxaliplatin is an intravenous cytotoxic small‑molecule API supplied as solutions or lyophilized powders for reconstitution
- It is used in combination regimens for advanced colorectal cancer and for adjuvant treatment of stage III colon cancer
- It is approved in major regulated markets including the US and Canada, with additional investigational use in some regions
Clinical Overview
Oxaliplatin undergoes rapid nonenzymatic biotransformation in physiologic media. Displacement of the oxalate group produces reactive monoaquo and diaquo platinum species that form covalent adducts with DNA. These species generate interstrand and intrastrand crosslinks, particularly at GG, AG, and GNG sites, disrupting DNA replication and transcription. Cytotoxicity is cell‑cycle nonspecific. The structural properties of its DNA adducts impair mismatch‑repair recognition, supporting activity in tumors resistant to other platinum agents.
Clinically, oxaliplatin is most commonly administered as part of the FOLFOX regimen with fluorouracil and leucovorin. Combination therapy yields additive antiproliferative effects in preclinical colon, mammary, and leukemia models and is established as a first‑line treatment. Investigational studies have evaluated broader applications, including non‑Hodgkin lymphoma, breast cancer, mesothelioma, and non‑small cell lung cancer.
Oxaliplatin displays complex pharmacokinetics due to rapid conversion to multiple platinum species. Protein binding of active derivatives is extensive and irreversible, with elimination primarily through renal excretion of platinum complexes. As a substrate of transporters such as OCT2 and BCRP, it presents potential for transporter‑mediated interactions.
Safety considerations include dose‑limiting peripheral sensory neuropathy, myelosuppression, gastrointestinal toxicity, and risk of hypersensitivity reactions. QTc prolongation has been reported. The drug is marketed in several regions, including under the trade name Eloxatin.
For API procurement, suppliers should demonstrate control of inorganic impurities, residual solvents, and polymorphic form, with full documentation of platinum assay and elemental impurity specifications to meet global regulatory requirements.
Identification & chemistry
| Generic name | Oxaliplatin |
|---|---|
| Molecule type | Small molecule |
| CAS | 61825-94-3 |
| UNII | 04ZR38536J |
| DrugBank ID | DB00526 |
Pharmacology
| Summary | Oxaliplatin forms reactive platinum complexes that covalently bind DNA, generating inter- and intrastrand crosslinks that disrupt replication and transcription. These DNA lesions produce cell‑cycle–nonspecific cytotoxicity and underlie its antitumor activity. In preclinical models, its activity is enhanced when used with fluorouracil. |
|---|---|
| Mechanism of action | Oxaliplatin undergoes nonenzymatic conversion in physiologic solutions to active derivatives via displacement of the labile oxalate ligand. Several transient reactive species are formed, including monoaquo and diaquo DACH platinum, which covalently bind with macromolecules. Both inter and intrastrand Pt-DNA crosslinks are formed. Crosslinks are formed between the N7 positions of two adjacent guanines (GG), adjacent adenine-guanines (AG), and guanines separated by an intervening nucleotide (GNG). These crosslinks inhibit DNA replication and transcription. Cytotoxicity is cell-cycle nonspecific. |
| Pharmacodynamics | In vivo studies have shown antitumor activities of oxaliplatin against colon carcinoma. In combination with fluorouracil, oxaliplatin exhibits in vitro and in vivo antiproliferative activity greater than either compound alone in several tumor models (HT29 [colon], GR [mammary], and L1210 [leukemia]). |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA | Humans | adduct, cross-linking/alkylation |
ADME / PK
| Absorption | The reactive oxaliplatin derivatives are present as a fraction of the unbound platinum in plasma ultrafiltrate. After a single 2-hour intravenous infusion of oxaliplatin at a dose of 85 mg/m<sup>2</sup>, pharmacokinetic parameters expressed as ultrafiltrable platinum was C<sub>max</sub> of 0.814 mcg/mL. Interpatient and intrapatient variability in ultrafiltrable platinum exposure (AUC<sub>0-48hr</sub>) assessed over 3 cycles was 23% and 6%, respectively. |
|---|---|
| Half-life | The decline of ultrafilterable platinum levels following oxaliplatin administration is triphasic with two distribution phases: t1/2α; 0.43 hours and t1/2β; 16.8 hours. This is followed by a long terminal elimination phase that lasts 391 hours (t1/2γ). |
| Protein binding | In patients, plasma protein binding of platinum is irreversible and is greater than 90%. The main binding proteins are albumin and gamma-globulins. Platinum also binds irreversibly and accumulates (approximately 2-fold) in erythrocytes, where it appears to have no relevant activity. No platinum accumulation was observed in plasma ultrafiltrate following 85 mg/m<sup>2</sup> every two weeks. |
| Metabolism | Oxaliplatin undergoes rapid and extensive nonenzymatic biotransformation. There is no evidence of cytochrome P450-mediated metabolism in vitro. Up to 17 platinum-containing derivatives have been observed in plasma ultrafiltrate samples from patients, including several cytotoxic species (monochloro DACH platinum, dichloro DACH platinum, and monoaquo and diaquo DACH platinum) and a number of noncytotoxic, conjugated species. |
| Route of elimination | The major route of platinum elimination is renal excretion. At five days after a single 2-hour infusion of ELOXATIN, urinary elimination accounted for about 54% of the platinum eliminated, with fecal excretion accounting for only about 2%. |
| Volume of distribution | After a single 2-hour intravenous infusion of oxaliplatin at a dose of 85 mg/m<sup>2</sup>, the volume of distribution is 440 L.At the end of a 2-hour infusion, approximately 15% of the administered platinum is present in the systemic circulation. The remaining 85% is rapidly distributed into tissues or eliminated in the urine. |
| Clearance | Platinum was cleared from plasma at a rate (10-17 L/h) that was similar to or exceeded the average human glomerular filtration rate (GFR; 7.5 L/h). The renal clearance of ultrafiltrable platinum is significantly correlated with GFR. |
Formulation & handling
- Oxaliplatin is formulated exclusively for parenteral use, typically as IV solutions or reconstituted lyophilized powders due to its poor suitability for oral delivery.
- The API is highly water‑soluble and chemically sensitive to chloride ions, requiring dilution only in dextrose solutions to avoid degradation.
- Light protection and controlled‑temperature handling are important to maintain stability of both the bulk API and reconstituted solutions.
Regulatory status
| Lifecycle | With key U.S. patents expiring between 2013 and 2017 and the Canadian patent expiring in 2015, the API has moved into a mature post‑exclusivity phase across its primary markets. Generic competition is likely well established in both the United States and Canada. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Oxaliplatin was originally developed by an originator company, but multiple manufacturers and packagers now participate in production and fill‑finish activities, reflecting a mature, multi‑source supply base. Branded products such as Eloxatin have established presence in the US and Canada, alongside wide availability of non‑branded versions. Patent expiries in both the US and Canada between 2013 and 2017 indicate that generic competition is already well established. |
|---|
Safety
| Toxicity | The maximum dose of oxaliplatin that has been administered in a single infusion is 825 mg. Several cases of overdoses have been reported with oxaliplatin. Adverse reactions observed following an overdosage were grade 4 thrombocytopenia (less than 25,000/mm3) without bleeding, anemia, sensory neuropathy (including paresthesia, dysesthesia, laryngospasm, and facial muscle spasms), gastrointestinal disorders (including nausea, vomiting, stomatitis, flatulence, abdomen enlarged and grade 4 intestinal obstruction), grade 4 dehydration, dyspnea, wheezing, chest pain, respiratory failure, severe bradycardia, and death. Closely monitor patients suspected of receiving an overdose, including for the adverse reactions described above, and administer appropriate supportive treatment. Based on its direct interaction with DNA, ELOXATIN can cause fetal harm when administered to a pregnant woman. The available human data do not establish the presence or absence of major birth defects or miscarriages related to the use of oxaliplatin. Reproductive toxicity studies demonstrated adverse effects on embryo-fetal development in rats at maternal doses that were below the recommended human dose based on body surface area. Advise a pregnant woman of the potential risk to a fetus. In the adjuvant treatment trial, 400 patients who received oxaliplatin with fluorouracil/leucovorin were greater than or equal to 65 years. The effect of oxaliplatin in patients greater than or equal to 65 years was not conclusive. Patients greater than or equal to 65 years receiving ELOXATIN experienced more diarrhea and grade 3-4 neutropenia (45% vs 39%) compared to patients less than 65 years. The AUC of unbound platinum in plasma ultrafiltrate was increased in patients with renal impairment. No dose reduction is recommended for patients with mild (creatinine clearance 50 to 79 mL/min) or moderate (creatinine clearance 30 to 49 mL/min) renal impairment, calculated by Cockcroft-Gault equation. Reduce the dose of oxaliplatin in patients with severe renal impairment (creatinine clearance less than 30 mL/min). Long-term animal studies have not been performed to evaluate the carcinogenic potential of oxaliplatin. Oxaliplatin was not mutagenic to bacteria (Ames test) but was mutagenic to mammalian cells in vitro (L5178Y mouse lymphoma assay). Oxaliplatin was clastogenic both in vitro (chromosome aberration in human lymphocytes) and in vivo (mouse bone marrow micronucleus assay). In a fertility study, male rats were given oxaliplatin at 0, 0.5, 1, or 2 mg/kg/day for five days every 21 days for a total of three cycles prior to mating with females that received two cycles of oxaliplatin on the same schedule. A dose of 2 mg/kg/day (less than one-seventh the recommended human dose on a body surface area basis) did not affect the pregnancy rate but resulted in 97% postimplantation loss (increased early resorptions, decreased live fetuses, decreased live births), and delayed growth (decreased fetal weight). Testicular damage, characterized by degeneration, hypoplasia, and atrophy, was observed in dogs administered oxaliplatin at 0.75 mg/kg/day (approximately one-sixth of the recommended human dose on a body surface area basis) × 5 days every 28 days for three cycles. A no-effect level was not identified. |
|---|
- Overexposure has produced severe hematologic suppression, acute sensory neuropathies, gastrointestinal obstruction, cardiopulmonary events, and fatalities, with reported single‑infusion doses up to 825 mg
- Demonstrates embryo‑fetal toxicity in animal studies and causes testicular degeneration in repeat‑dose studies
- No-effect levels for reproductive endpoints were not established
Oxaliplatin is a type of Platinum compounds
Platinum compounds are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that have gained significant attention due to their potential therapeutic applications. These compounds contain platinum as a central element and exhibit remarkable anti-cancer properties, making them valuable in the field of oncology.
Platinum compounds, such as cisplatin, carboplatin, and oxaliplatin, are widely used in chemotherapy for the treatment of various types of cancers, including testicular, ovarian, lung, and colorectal cancer. These APIs work by interfering with the DNA of cancer cells, preventing their replication and leading to cell death.
One of the notable advantages of platinum compounds is their broad-spectrum activity against different types of tumors. They can be used as single agents or in combination with other drugs to enhance their effectiveness and overcome resistance. Platinum compounds are often administered intravenously and undergo metabolic activation within the body to their active form.
Despite their therapeutic benefits, platinum compounds can also cause side effects, such as nephrotoxicity, neurotoxicity, and myelosuppression. Therefore, careful monitoring and dose adjustments are necessary to minimize these adverse effects.
In conclusion, platinum compounds represent a vital subcategory of pharmaceutical APIs with potent anti-cancer properties. Their versatility and effectiveness in combating various types of tumors make them indispensable in modern oncology. Continued research and development in this field aim to improve their therapeutic profile and reduce associated side effects, ultimately benefiting cancer patients worldwide.
Oxaliplatin (Platinum compounds), 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.
Oxaliplatin API manufacturers & distributors
Compare qualified Oxaliplatin API suppliers worldwide. We currently have 27 companies offering Oxaliplatin API, with manufacturing taking place in 11 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 |
|---|---|---|---|---|---|
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, GMP, HALAL, ISO9001, Kosher, MSDS | 250 products |
| AXXO GmbH | Distributor | Germany | European Union | CEP, CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CEP, CoA, EDMF/ASMF, GMP, MSDS, USDMF, WC | 235 products |
| Chongqing Taihao | Producer | China | China | CoA, WC | 7 products |
| Cipla | Producer | India | India | CEP, CoA, GMP, KDMF, USDMF, WC | 164 products |
| Debiopharm Int. | Producer | Switzerland | Switzerland | CEP, CoA, GMP | 1 products |
| Emcure Pharma | Producer | India | India | CoA, GMP, USDMF, WC | 80 products |
| Eriochem | Producer | Argentina | Argentina | CEP, CoA, FDA, GMP | 2 products |
| Heraeus | Producer | Germany | Germany | CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF | 10 products |
| Hetero Labs | Producer | India | Unknown | CEP, CoA, FDA, GMP, USDMF, WC | 90 products |
| Hospira Boulder | Producer | United States | United States | CEP, CoA, USDMF | 5 products |
| Hubei Haosun Pharma | Producer | China | China | CEP, CoA, FDA, USDMF | 8 products |
| Justesa Imagen | Producer | Spain | Spain | CoA, GMP | 15 products |
| Laurus Labs | Producer | India | India | CEP, CoA, GMP, USDMF, WC | 50 products |
| Mac Chem Products | Producer | India | India | CoA, GMP, USDMF, WC | 25 products |
| Polymed Therapeutics | Producer | United States | United States | CEP, CoA, USDMF | 11 products |
| Shandong Boyuan | Producer | China | China | BSE/TSE, CEP, CoA, GMP, JDMF, MSDS, USDMF, WC | 55 products |
| Shanghai Jinhe Bio-Pharma | Producer | China | China | CoA | 12 products |
| Shilpa Medicare Ltd | Producer | India | India | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF, WC | 54 products |
| Sicor De México | Producer | Mexico | Mexico | CoA, JDMF | 11 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 757 products |
| Socosur | Distributor | France | Unknown | CoA | 21 products |
| Sun Pharma | Producer | India | India | CEP, CoA, JDMF, USDMF, WC | 219 products |
| Suzhou Lixin Pharmaceutic... | Producer | China | China | BSE/TSE, CoA, GMP, MSDS | 34 products |
| Umicore Argentina | Producer | Argentina | Argentina | CEP, CoA, FDA, GMP, KDMF, USDMF | 4 products |
| Vuab Pharma | Producer | Czech Republic | Czech Republic | CEP, CoA, FDA, GMP, USDMF | 3 products |
| Zhejiang Hisun Pharma | Producer | China | China | CoA, USDMF | 69 products |
When sending a request, specify which Oxaliplatin 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 Oxaliplatin 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.
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Technical
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Regulatory
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