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Mitomycin | CAS No: 50-07-7 | GMP-certified suppliers
A medication that treats malignant neoplasms of the lip, oral cavity, digestive organs, breast, and urinary bladder, and is used adjunctively in glaucoma surgery to reduce scarring.
Therapeutic categories
Primary indications
- For treatment of malignant neoplasm of lip, oral cavity, pharynx, digestive organs, peritoneum, female breast, and urinary bladder
- Also used as an adjunct to ab externo glaucoma surgery
- Mitomycin is also indicated as a pyelocalyceal solution for the treatment of adults with low-grade upper tract urothelial cancer (LG-UTUC)
Product Snapshot
- Mitomycin is a lyophilized powder formulated for injectable and solution preparations suitable for intravenous, intra-arterial, intravesical, ureteral, and ophthalmic administration
- It is primarily indicated for the treatment of various malignant neoplasms including those of the lip, oral cavity, pharynx, digestive organs, peritoneum, breast, and urinary bladder, as well as an adjunct in glaucoma surgery and treatment of low-grade upper tract urothelial cancer
- Mitomycin is approved and marketed in the United States and Canada
Clinical Overview
Clinically, mitomycin is approved for the treatment of malignant neoplasms involving the lip, oral cavity, pharynx, digestive organs, peritoneum, female breast, and urinary bladder. More recently, in April 2020, a pyelocalyceal formulation was approved for managing low-grade upper tract urothelial cancer (LG-UTUC) in adults. Additionally, mitomycin is used adjunctively during ab externo glaucoma surgeries to reduce scarring.
Pharmacodynamically, mitomycin exhibits antitumor activity by selective inhibition of DNA synthesis. Its efficacy correlates with the guanine-cytosine content of target DNA regions. In vitro studies demonstrate immunosuppressive effects, including inhibition of B and T lymphocyte and macrophage proliferation, impaired antigen presentation, and reduced secretion of cytokines such as interferon gamma, TNF-alpha, and IL-2. The drug operates independently of cell cycle phase due to its activation in vivo into bifunctional and trifunctional alkylating metabolites that induce DNA cross-linking.
Pharmacokinetic data indicate mitomycin undergoes bioactivation enzymatically within tissues; its metabolic profile contributes to both therapeutic effects and dose-limiting toxicities. Safety considerations include myelosuppression, renal toxicity, and cardiotoxicity, mandating careful dosing and monitoring. Mitomycin has a narrow therapeutic index and requires appropriate handling to mitigate cytotoxic risks.
Mitomycin is available under various brand names globally and remains a component of cancer treatment protocols and surgical adjunct therapies. For API procurement, suppliers should ensure compliance with Good Manufacturing Practices (GMP) and verify batch consistency in purity, potency, and absence of impurities. Given mitomycin’s instability and cytotoxic nature, specialized handling and storage conditions are essential to maintain quality during transport and formulation.
Identification & chemistry
| Generic name | Mitomycin |
|---|---|
| Molecule type | Small molecule |
| CAS | 50-07-7 |
| UNII | 50SG953SK6 |
| DrugBank ID | DB00305 |
Pharmacology
| Summary | Mitomycin is an antineoplastic antibiotic that exerts cytotoxic effects through in vivo activation to alkylating metabolites, causing DNA cross-linking and inhibition of DNA synthesis. Its mechanism is cell cycle phase-nonspecific, leading to suppression of DNA, RNA, and protein synthesis at higher concentrations. Additionally, mitomycin modulates immune responses by inhibiting proliferation of B cells, T cells, and macrophages and impairing cytokine secretion. |
|---|---|
| Mechanism of action | Mitomycin is activated in vivo to a bifunctional and trifunctional alkylating agent. Binding to DNA leads to cross-linking and inhibition of DNA synthesis and function. Mitomycin is cell cycle phase-nonspecific. |
| Pharmacodynamics | Mitomycin is one of the older chemotherapy drugs, which has been around and in use for decades. It is an antibiotic which has been shown to have antitumor activity. Mitomycin selectively inhibits the synthesis of deoxyribonucleic acid (DNA). The guanine and cytosine content correlates with the degree of mitomycin-induced cross-linking. At high concentrations of the drug, cellular RNA and protein synthesis are also suppressed. Mitomycin has been shown <i>in vitro</i> to inhibit B cell, T cell, and macrophage proliferation and impair antigen presentation, as well as the secretion of interferon gamma, TNFa, and IL-2. |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA | Humans | cross-linking/alkylation |
ADME / PK
| Absorption | Erratic. |
|---|---|
| Half-life | 8-48 min |
| Metabolism | Primarily hepatic, some in various other tissues. |
| Route of elimination | Approximately 10% of a dose of mitomycin is excreted unchanged in the urine. |
Formulation & handling
- Mitomycin is formulated primarily for parenteral administration including intravenous, intravesical, intra-arterial, and ureteral routes with no oral forms available.
- As a small molecule with good water solubility, Mitomycin is typically supplied as lyophilized powder for reconstitution to ensure stability during storage and handling.
- The compound's stability requires protection from moisture and possible light exposure, necessitating appropriate storage and handling protocols for solution preparation.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is protected by patents in the United States with expiry dates ranging from mid-2026 to early 2029, and is currently marketed in the US and Canada. The product is approaching patent expiration, indicating a transition toward increased generic competition in these markets. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | The manufacturing landscape for Mitomycin features several originator companies involved in production and packaging, serving primarily the US and Canadian markets. Branded products are present under multiple names, indicating established market penetration in North America. Patent protection extends through 2026 to 2029 in the United States, suggesting that generic competition is likely to increase as these patents near expiration. |
|---|
Safety
| Toxicity | Oral, mouse: LD<sub>50</sub> = 23 mg/kg; Oral, rat: LD<sub>50</sub> = 30 mg/kg. Symptoms of overdose include nausea and vomiting. |
|---|
- Handle with appropriate personal protective equipment due to high acute toxicity (oral LD₅₀ in rodents approximately 23–30 mg/kg)
- Avoid inhalation, ingestion, and skin contact to prevent systemic exposure
- Follow established procedures for safe containment and disposal to mitigate risks of adverse effects
Mitomycin is a type of Cytostatic antibiotics
Cytostatic antibiotics are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in the treatment of various types of cancer. These antibiotics possess powerful cytostatic or cell-inhibiting properties, which impede the growth and division of cancer cells.
Cytostatic antibiotics work by selectively targeting and inhibiting specific enzymes and proteins necessary for the replication and proliferation of cancer cells. By interrupting these vital cellular processes, these APIs effectively hinder the progression of cancer and prevent the spread of malignant cells.
One prominent example of a cytostatic antibiotic is Doxorubicin, which belongs to the anthracycline class of antibiotics. Doxorubicin functions by intercalating with DNA molecules, preventing DNA replication and inhibiting the activity of topoisomerase enzymes. These mechanisms effectively impede the growth and division of cancer cells.
Another commonly used cytostatic antibiotic is Mitomycin C. It exerts its anticancer effects by inducing DNA cross-linking, leading to the inhibition of DNA synthesis and cell division. This antibiotic is particularly effective against a variety of solid tumors.
Cytostatic antibiotics are administered in different ways, such as intravenous injection or oral consumption, depending on the specific drug. These APIs are often used in combination with other chemotherapy agents or treatment modalities to achieve optimal therapeutic outcomes.
In conclusion, cytostatic antibiotics are a vital subcategory of pharmaceutical APIs used in cancer treatment. Their ability to inhibit cell growth and division makes them essential in combating various types of cancer, ultimately improving patient outcomes.
Mitomycin (Cytostatic antibiotics), 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.
Mitomycin API manufacturers & distributors
Compare qualified Mitomycin API suppliers worldwide. We currently have 3 companies offering Mitomycin API, with manufacturing taking place in 2 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, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Sicor | Producer | Italy | Italy | CoA, GMP | 47 products |
| Zhejiang Hisun Pharma | Producer | China | China | CoA, USDMF, WC | 69 products |
When sending a request, specify which Mitomycin 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.).
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