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Bleomycin API Manufacturers & Suppliers
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Bleomycin | CAS No: 11056-06-7 | GMP-certified suppliers
A medication that supports palliative management of malignant respiratory tract neoplasms, squamous cell carcinomas, and select lymphomas to address key oncologic treatment needs.
Therapeutic categories
Primary indications
- For palliative treatment in the management malignant neoplasm (trachea, bronchus, lung), squamous cell carcinoma, and lymphomas
Product Snapshot
- Bleomycin is supplied as an injectable antitumor antibiotic in multiple lyophilized and solution powder formulations for parenteral use
- It is used in oncology for malignant neoplasms of the trachea, bronchus, and lung, for squamous cell carcinoma, and for lymphomas
- It is approved in the US and Canada with some investigational status noted in certain markets
Clinical Overview
Bleomycin exhibits antitumor activity through selective inhibition of DNA synthesis, with reduced effects on RNA and protein synthesis at therapeutic concentrations. Its cytotoxicity is most pronounced during the G2 and M phases of the cell cycle. Pharmacodynamic studies show suppression of B cell, T cell, and macrophage proliferation, along with reduced antigen presentation and decreased secretion of interferon gamma, TNF alpha, and IL‑2. These immunomodulatory properties are secondary to its primary DNA-damaging activity.
The mechanism of action involves metal ion chelation, mainly with iron, forming a reactive complex that interacts with oxygen to generate free radicals. These species induce single- and double-strand DNA breaks, thereby impairing DNA replication and leading to cell death. The process is oxygen dependent and contributes to the drug’s antineoplastic effects across various solid tumor types.
Absorption following systemic administration is incomplete, and distribution is limited by low plasma protein binding. Bleomycin is primarily cleared by renal excretion, and reduced clearance in renal impairment increases systemic exposure. Pulmonary and dermatologic toxicities are the most significant safety concerns, with pulmonary fibrosis representing a dose-limiting risk. The compound is categorized as having a narrow therapeutic index, necessitating careful dosing and monitoring.
Common usage contexts include combination chemotherapy regimens for germ cell tumors and Hodgkin lymphoma, often under established brand formulations in parenteral form.
For API procurement, sourcing should prioritize manufacturers with demonstrated control of glycopeptide complexity, validated metal ion content limits, and robust characterization methods to ensure batch consistency and regulatory compliance.
Identification & chemistry
| Generic name | Bleomycin |
|---|---|
| Molecule type | Small molecule |
| CAS | 11056-06-7 |
| UNII | 40S1VHN69B |
| DrugBank ID | DB00290 |
Pharmacology
| Summary | Bleomycin is an antitumor antibiotic that exerts its primary activity by inducing DNA strand breaks, largely through metal‑ion–dependent free‑radical formation in the presence of oxygen. This leads to inhibition of DNA synthesis, with secondary suppression of RNA and protein synthesis at higher concentrations, and produces cell‑cycle effects most prominent in the G2 and M phases. The drug also demonstrates immunosuppressive activity in vitro, including reduced proliferation of lymphoid and myeloid cells and diminished cytokine secretion. |
|---|---|
| Mechanism of action | Although the exact mechanism of action of bleomycin is unknown, available evidence would seem to indicate that the main mode of action is the inhibition of DNA synthesis with some evidence of lesser inhibition of RNA and protein synthesis. As evident in _in vitro_ studies, the DNA-cleaving actions of bleomycin is dependent on oxygen and metal ions. It is believed that bleomycin chelates metal ions (primarily iron) producing a pseudoenzyme that reacts with oxygen to produce superoxide and hydroxide free radicals that cleave DNA. |
| Pharmacodynamics | Bleomycin is an antibiotic which has been shown to have antitumor activity. Bleomycin 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. Bleomycin 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. The antibiotic antitumor drugs are cell cycle-nonspecific except for Bleomycin (which has major effects in G2 and M phases). |
Targets
| Target | Organism | Actions |
|---|---|---|
| DNA | Humans | cleavage |
| DNA ligase 1 | Humans | inhibitor |
| DNA ligase 3 | Humans | inhibitor |
ADME / PK
| Absorption | Systemic absorption is approximately 45%. |
|---|---|
| Half-life | 115 minutes |
| Protein binding | 1% |
| Metabolism | Hepatic |
| Route of elimination | It was reported that patients with moderately severe renal failure excreted less than 20% of the dose in the urine. |
Formulation & handling
- Bleomycin is supplied as a lyophilized powder for parenteral use, requiring reconstitution immediately before administration due to limited aqueous solubility.
- Its high molecular weight and glycopeptide structure make it unsuitable for oral delivery, with parenteral routes preferred to ensure bioavailability.
- Handle under conditions that minimize moisture exposure and avoid excessive agitation, as the glycopeptide complex can be sensitive to hydrolysis and mechanical stress after reconstitution.
Regulatory status
| Lifecycle | Patent protection for the API in the US and Canada is reaching or has passed typical expiry timelines, indicating a mature market stage. Both markets are characterized by established availability and increasing generic participation where patent barriers no longer apply. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Bleomycin’s supply landscape includes the originator Bristol‑Myers Squibb alongside multiple established generic manufacturers that handle both production and packaging. Branded Bleomycin products such as Blenoxane have been commercially available in the US and Canada, indicating mature global distribution primarily in North American markets. Patent expiry has long passed, and the presence of several generic suppliers reflects an established and competitive generic market. |
|---|
Safety
| Toxicity | Excessive exposure may cause fever, chills, nausea, vomiting, mental, confusion, and wheezing. Bleomycin may cause irritation to eyes, skin and respiratory tract. It may also cause a darkening or thickening of the skin. It may cause an allergic reaction. |
|---|
- In concentrated form, the compound can produce systemic effects such as fever, chills, nausea, vomiting, respiratory irritation, and neurocognitive disturbances (e
- G
- , confusion) following excessive exposure
Bleomycin 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.
Bleomycin (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.
Bleomycin API manufacturers & distributors
Compare qualified Bleomycin API suppliers worldwide. We currently have 2 companies offering Bleomycin 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 |
|---|---|---|---|---|---|
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Zhejiang Hisun Pharma | Producer | China | China | CEP, CoA, GMP, USDMF, WC | 69 products |
When sending a request, specify which Bleomycin 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 Bleomycin 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.
Frequently asked questions about Bleomycin API
Sourcing
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Technical
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Regulatory
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