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United States|
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Employees: 150
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CoA
Producer
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Employees: 200+
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Polymyxin B | CAS No: 1404-26-8 | GMP-certified suppliers
A medication that treats Pseudomonas aeruginosa infections of the urinary tract, meninges, and bloodstream when reliable systemic antibacterial options are limited.
Therapeutic categories
Alimentary Tract and MetabolismAmino Acids, Peptides, and ProteinsAnti-Bacterial AgentsAnti-Infective AgentsAntibacterials for Systemic UseAntidiarrheals, Intestinal Antiinflammatory/antiinfective Agents
Generic name
Polymyxin B
Molecule type
small molecule
CAS number
1404-26-8
DrugBank ID
DB00781
Approval status
Approved drug, Vet_approved drug
ATC code
S02AA11
Primary indications
- Polymyxin B is indicated for the treatment of infections of the urinary tract, meninges, and blood stream, caused by susceptible strains of <i>Pseudomonas aeruginosa</i>[FDA Label]
Product Snapshot
- Polymyxin B is an antibacterial small molecule available in injectable, topical, ophthalmic, otic, inhalation, and various solution-based formulations
- It is used for managing infections of the urinary tract, meninges, and bloodstream caused by susceptible Pseudomonas aeruginosa
- It is approved for human and veterinary use in the US and Canada
Clinical Overview
Polymyxin B (CAS 1404-26-8) is a cyclic polypeptide antibiotic discovered in the 1940s and reserved for serious infections caused by susceptible Gram negative organisms. Its clinical use focuses on infections of the urinary tract, meninges, and bloodstream due to Pseudomonas aeruginosa. It is not active against Gram positive bacteria, fungi, Gram negative cocci, or anaerobic organisms, which limits its therapeutic scope.
Polymyxin B exerts bactericidal activity by targeting the outer membrane of Gram negative bacteria. Its positively charged diaminobutyric acid residues bind the negatively charged phosphate groups of lipid A within lipopolysaccharide. This interaction displaces stabilizing calcium and magnesium ions, disrupts membrane integrity, increases permeability, and leads to leakage of intracellular contents. The compound also binds and neutralizes lipopolysaccharide released during cell lysis, reducing endotoxin-driven inflammatory responses. In addition, inhibition of type II NADH‑quinone oxidoreductases in the inner membrane interferes with bacterial respiration.
Absorption after enteral administration is poor, which aligns with its primary use via parenteral or topical routes. The drug undergoes negligible metabolism, and most circulating drug is eliminated unchanged. Because Polymyxin B has a narrow therapeutic index, careful dose selection and monitoring are required, particularly in patients with renal impairment.
Major toxicity concerns include nephrotoxicity and neurotoxicity, which limit use to situations where alternative agents are unsuitable or resistance patterns necessitate its selection. Clinical formulations often combine Polymyxin B with other antimicrobials for specific topical or ophthalmic uses, and its usage pattern reflects stewardship principles aimed at minimizing toxicity and preventing resistance.
For API procurement, sourcing should prioritize manufacturers that provide validated impurity profiles, consistent polymyxin composition, and robust controls for peptide heterogeneity. Compliance with pharmacopeial specifications and reliable documentation of quality and traceability is essential due to the compound’s narrow therapeutic index and safety-sensitive application.
Polymyxin B exerts bactericidal activity by targeting the outer membrane of Gram negative bacteria. Its positively charged diaminobutyric acid residues bind the negatively charged phosphate groups of lipid A within lipopolysaccharide. This interaction displaces stabilizing calcium and magnesium ions, disrupts membrane integrity, increases permeability, and leads to leakage of intracellular contents. The compound also binds and neutralizes lipopolysaccharide released during cell lysis, reducing endotoxin-driven inflammatory responses. In addition, inhibition of type II NADH‑quinone oxidoreductases in the inner membrane interferes with bacterial respiration.
Absorption after enteral administration is poor, which aligns with its primary use via parenteral or topical routes. The drug undergoes negligible metabolism, and most circulating drug is eliminated unchanged. Because Polymyxin B has a narrow therapeutic index, careful dose selection and monitoring are required, particularly in patients with renal impairment.
Major toxicity concerns include nephrotoxicity and neurotoxicity, which limit use to situations where alternative agents are unsuitable or resistance patterns necessitate its selection. Clinical formulations often combine Polymyxin B with other antimicrobials for specific topical or ophthalmic uses, and its usage pattern reflects stewardship principles aimed at minimizing toxicity and preventing resistance.
For API procurement, sourcing should prioritize manufacturers that provide validated impurity profiles, consistent polymyxin composition, and robust controls for peptide heterogeneity. Compliance with pharmacopeial specifications and reliable documentation of quality and traceability is essential due to the compound’s narrow therapeutic index and safety-sensitive application.
Identification & chemistry
| Generic name | Polymyxin B |
|---|---|
| Molecule type | Small molecule |
| CAS | 1404-26-8 |
| UNII | J2VZ07J96K |
| DrugBank ID | DB00781 |
Pharmacology
| Summary | Polymyxin B is a cationic antimicrobial peptide that binds lipid A in the outer membrane of Gram‑negative bacteria, displacing stabilizing cations and disrupting membrane integrity. It also neutralizes free lipopolysaccharide and inhibits type II NADH‑quinone oxidoreductases in the inner membrane, impairing bacterial respiration. These combined actions lead to rapid membrane permeabilization and death of susceptible Gram‑negative organisms such as Pseudomonas aeruginosa. |
|---|---|
| Mechanism of action | The alpha and gamma diaminobutyric acid of a positively charged polymyxin B forms an electrostatic interaction with the phosphate groups of a negatively charged lipid A on the outer membrane of a Gram negative bacterium. Calcium and Magnesium ions are displaced from phosphates of the membrane lipids, destabalising the lipopolysaccharide (LPS), increasing membrane permeability, causing cytoplasmic leaking, and killing the cell. Polymyxin B can also bind and neutralize LPS released during bacterial lysis, preventing reactions to endotoxin. A third activity of polymyxin B is the inhibition of type II NADH-quinone oxidoreductases in the bacterial inner membrane, which are essential for respiration. Polymyxin is active against common Gram negative bacteria but not Gram negative cocci, Gram positive bacteria, or anaerobic bacteria. |
| Pharmacodynamics | Polymyxin B is an antibiotic that disrupts the outer cell membrane of Gram negative bacteria, binds and neutralizes lipopolysaccharide, and inhibits respiration of Gram-negative bacterial cells. Polymyxin B can be given by a number of routes to treat susceptible Gram negative bacterial infections. Absorption of the drug is poor (though not necessary for most of its activity) and the excreted drug is unchanged by metabolic processes. Polymyxin B is generally indicated for susceptible Gram negative infections of the urinary tract, meninges, and blood stream[FDA Label]. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Bacterial outer membrane | Bacteria | incorporation into and destabilization |
ADME / PK
| Absorption | Administration by the oral route does not lead to absorption. |
|---|---|
| Half-life | In one study the half life was 9 to 11.5 hours. However, a Canadian monograph states the half life to be 6 hours, and 48-72 hours in patients with renal insufficiency. |
| Protein binding | Polymyxin B is 79% to 92% bound to proteins. Polymyxin B is likely 92 to 99% protein bound in circulation, though the exact proteins have not been identified. |
| Metabolism | There is little data available for the metabolism of polymyxin B. In one study, <1% of polymyxin B was eliminated through the kidneys and it had not been metabolised. Polymyxin B has also been found in bile, not having undergone metabolic processes. |
| Route of elimination | Polymyxin B is proposed to be primarily eliminated through renal tubular reabsorption and non-renal pathways. Urine collection in humans and animals show <5% of polymyxin B eliminated from the kidneys. However, a Canadian product monograph states the drug is primarily eliminated through the kidneys and that 60% of polymyxin B is recovered in the urine. This discrepancy can be explained by the 12 to 24 hour lag time between administration and significant elimination of polymyxin B. Non-renal elimination is not well understood but all 4 components of polymyxin B have been detected in bile. |
| Volume of distribution | 1 compartment models estimate the volume of distribution to be 34.3L to 47.2L. However, the general consensus is that the volume of distribution is yet to be determined. |
| Clearance | 1 compartment models estimate clearance to be 2.37L/h to 2.5L/h. |
Formulation & handling
- Polymyxin B is a cyclic peptide antibiotic with poor oral absorption, so clinical use relies on topical, ophthalmic, inhalation, and parenteral formulations.
- Lyophilized injectable presentations require careful reconstitution and protection from excessive heat and moisture due to limited aqueous solubility and peptide‑like degradation pathways.
- Topical and ophthalmic products benefit from stabilized aqueous or semi-solid vehicles to maintain activity given the compound’s hydrophilicity and sensitivity to adsorption onto plastics.
Regulatory status
| Lifecycle | Patent protection for the API is expired or nearing expiry, indicating a transition toward a mature market phase in the US and Canada. Commercial presence in both markets suggests stable, established utilization with increasing generic participation. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Polymyxin B is an established, off‑patent antibiotic with no active exclusivities, and manufacturing is supplied entirely by generic drug producers rather than a current originator. Branded presence in the US and Canada is primarily through combination first‑aid and antibiotic kits rather than standalone proprietary products. Patent expiry long ago supports broad existing generic competition and a mature global supply base. |
|---|
Safety
| Toxicity | Nephrotoxicity can occur in patients as polymyxin B is thought to accumulate in renal cells after renal tubular reabsorption. This accumulation can lead to apoptosis of renal cells and decrease in renal function. In recent studies, acute kidney injury (AKI) has been seen in 31.3% to 39.4% of patients receiving polymyxin B. Overdose cases can cause neuromuscular block leading to apnea, muscular weakness, vertigo, transient facial parasthesia, slurred speed, vasomotor instability, visual disturbance, confusion, psychosis, and respiratory arrest. Renal failure has also been seen through decreased urine output, and increased serum concentrations of blood urea nitrogen. Overdose of polymyxin B is treated by stopping the drug and beginning symptomatic treatment. Intravenous administration of mannitol may enhance renal clearance, and hemodialysis may manage renal complications. Safety of polymyxin B has not been established in pregnancy, breast feeding, pediatrics, and geriatrics. Polymyxin B should no be used in pregnancy unless the benefit outweighs the risk. Nursing mothers should either stop nursing or stop polymyxin B treatment depending on the risks to both the mother and child. Pediatric patients should be frequently monitored for renal function and no dosing information is available in children under 2 years of age. Geriatric patients should have renal function assessed before and regularly during therapy. |
|---|
High Level Warnings:
- Demonstrates dose‑dependent nephrotoxicity linked to renal tubular accumulation, with reported acute kidney injury incidence around one‑third of exposed subjects
- High systemic exposure or overdose may precipitate neuromuscular blockade, CNS effects, and respiratory compromise, alongside renal function deterioration
- Safety data remain limited for pregnancy, lactation, pediatric, and geriatric populations, reflecting incomplete characterization of exposure‑related risks in these groups
Polymyxin B Sulfate is a type of Antibacterials
Antibacterials, a category of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in combating bacterial infections. These APIs are chemical compounds that target and inhibit the growth or kill bacteria, helping to eliminate harmful bacterial pathogens from the body.
Antibacterials are essential for the treatment of various bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and more. They are commonly prescribed by healthcare professionals to combat both mild and severe bacterial infections.
Within the category of antibacterials, there are different classes and subclasses of APIs, each with distinct mechanisms of action and target bacteria. Some commonly used antibacterials include penicillins, cephalosporins, tetracyclines, macrolides, and fluoroquinolones. These APIs work by interfering with various aspects of bacterial cellular processes, such as cell wall synthesis, protein synthesis, DNA replication, or enzyme activity.
The development and production of antibacterial APIs require stringent quality control measures to ensure their safety, efficacy, and purity. Pharmaceutical manufacturers must adhere to Good Manufacturing Practices (GMP) and follow rigorous testing protocols to guarantee the quality and consistency of these APIs.
As bacterial resistance to antibiotics continues to be a significant concern, ongoing research and development efforts aim to discover and develop new antibacterial APIs. The evolution of antibacterials plays a crucial role in combating emerging bacterial strains and ensuring effective treatment options for infectious diseases.
In summary, antibacterials are a vital category of pharmaceutical APIs used to treat bacterial infections. They are designed to inhibit or kill bacteria, and their development requires strict adherence to quality control standards. By continually advancing research in this field, scientists and pharmaceutical companies can contribute to the ongoing battle against bacterial infections.
Polymyxin B Sulfate API manufacturers & distributors
Compare qualified Polymyxin B Sulfate API suppliers worldwide. We currently have 13 companies offering Polymyxin B Sulfate API, with manufacturing taking place in 6 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 |
|---|---|---|---|---|---|
| Antoney Biotech | Producer | China | China | CoA, FDA, MSDS, USDMF | 2 products |
| Biotika A.S. | Producer | Slovenia | Slovenia | CEP, CoA, GMP, USDMF | 2 products |
| Caesar & Loretz GmbH (CAE... | Distributor | Germany | Unknown | BSE/TSE, CoA, GMP, ISO9001, MSDS | 211 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 235 products |
| Chr. Olesen Group | Distributor | Denmark | China, Denmark | CEP, CoA, GMP, MSDS, USDMF | 252 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Denmark | CoA, GMP, ISO9001, MSDS, WC | 170 products |
| Gonane Pharma | Producer | India | India | BSE/TSE, CoA, GMP, MSDS | 166 products |
| K. Sevantilal & Co. | Producer | India | India | CoA | 8 products |
| Pharm Rx Chemical Corp | Distributor | United States | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 166 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CoA, GMP, ISO9001, MSDS | 144 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 757 products |
| Xellia | Producer | Denmark | Unknown | CEP, CoA, FDA, GMP, USDMF | 9 products |
| Yancheng YouHua | Producer | China | China | CoA, USDMF | 2 products |
When sending a request, specify which Polymyxin B Sulfate 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 Polymyxin B Sulfate 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 Polymyxin B Sulfate API
Sourcing
What matters most when sourcing GMP-grade Polymyxin B Sulfate?
When sourcing GMP‑grade Polymyxin B Sulfate, it is essential to verify compliance with US and Canadian regulatory standards, including appropriate GMP documentation and audit history. Consistent quality and batch‑to‑batch reproducibility are important given its use in sterile and combination products. Because supply is entirely generic, confirming the reliability and capacity of the manufacturer helps ensure continuity. The mature global market also makes verification of true GMP status and traceability a key consideration.
Which documents are typically required when sourcing Polymyxin B Sulfate API?
Request the core API documentation set: CoA (14 companies), MSDS (10 companies), GMP (10 companies), USDMF (8 companies), ISO9001 (5 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Polymyxin B Sulfate API?
Known or reported manufacturers for Polymyxin B Sulfate: Duchefa Farma B.V., Caesar & Loretz GmbH (CAELO), Xi'an Tian Guangyuan Biotech Co.,Ltd, Changzhou Comwin Fine Chemicals Co., Ltd, Chr. Olesen Group, Pharm Rx Chemical Corp, Sinoway industrial Co.,Ltd, Rochem International, Inc., Gonane Pharma. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Polymyxin B Sulfate API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Polymyxin B Sulfate manufacturers?
Audit reports may be requested for Polymyxin B Sulfate: 2 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Polymyxin B Sulfate API on Pharmaoffer?
Reported supplier count for Polymyxin B Sulfate: 14 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Polymyxin B Sulfate API?
Production countries reported for Polymyxin B Sulfate: China (7 producers), Denmark (2 producers), India (2 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Polymyxin B Sulfate usually hold?
Common certifications for Polymyxin B Sulfate suppliers: CoA (14 companies), MSDS (10 companies), GMP (10 companies), USDMF (8 companies), ISO9001 (5 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Polymyxin B Sulfate (CAS 1404-26-8) used for?
Polymyxin B Sulfate is used to treat serious infections caused by susceptible Gram‑negative bacteria, particularly when other options are limited. Its clinical use includes severe urinary tract, bloodstream, and meningeal infections due to organisms such as Pseudomonas aeruginosa. It is also incorporated into certain topical and ophthalmic preparations for targeted antimicrobial therapy.
Which therapeutic class does Polymyxin B Sulfate fall into?
Polymyxin B Sulfate belongs to the following therapeutic categories: Alimentary Tract and Metabolism, Amino Acids, Peptides, and Proteins, Anti-Bacterial Agents, Anti-Infective Agents, Antibacterials for Systemic Use. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Polymyxin B Sulfate mainly prescribed for?
The primary indications for Polymyxin B Sulfate: Polymyxin B Sulfate is indicated for the treatment of infections of the urinary tract, meninges, and blood stream, caused by susceptible strains of Pseudomonas aeruginosa[FDA Label]. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Polymyxin B Sulfate work?
The alpha and gamma diaminobutyric acid of a positively charged Polymyxin B Sulfate forms an electrostatic interaction with the phosphate groups of a negatively charged lipid A on the outer membrane of a Gram negative bacterium. Calcium and Magnesium ions are displaced from phosphates of the membrane lipids, destabalising the lipopolysaccharide (LPS), increasing membrane permeability, causing cytoplasmic leaking, and killing the cell.
Polymyxin B Sulfate can also bind and neutralize LPS released during bacterial lysis, preventing reactions to endotoxin.
A third activity of Polymyxin B Sulfate is the inhibition of type II NADH-quinone oxidoreductases in the bacterial inner membrane, which are essential for respiration.
Polymyxin is active against common Gram negative bacteria but not Gram negative cocci, Gram positive bacteria, or anaerobic bacteria.
What should someone know about the safety or toxicity profile of Polymyxin B Sulfate?
Polymyxin B Sulfate has a narrow therapeutic index, with dose‑dependent nephrotoxicity that can lead to acute kidney injury in a substantial proportion of exposed patients. High systemic exposure or overdose may cause neuromuscular blockade, CNS effects, respiratory compromise, and worsening renal function. Safety data are limited in pregnancy, lactation, pediatric, and geriatric populations, so exposure‑related risks in these groups are not fully characterized. Careful dose selection and monitoring are required, especially in individuals with renal impairment.
What are important formulation and handling considerations for Polymyxin B Sulfate as an API?
Polymyxin B’s poor oral absorption necessitates topical, ophthalmic, inhalation, or parenteral formulations, with injectable products commonly supplied as lyophilized powder to limit peptide degradation. Reconstitution should avoid excessive heat and prolonged exposure to moisture because of limited aqueous solubility and susceptibility to hydrolysis. For topical and ophthalmic forms, stabilized aqueous or semi‑solid vehicles help maintain activity and reduce adsorption to plastics. Handling should minimize conditions that accelerate peptide degradation.
Is Polymyxin B Sulfate a small molecule?
Polymyxin B Sulfate is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Polymyxin B Sulfate?
Oral formulations of polymyxin B are not used clinically because the drug is not absorbed by this route, so oral‑specific stability concerns are not described. Known stability issues relate to its peptide structure, which is sensitive to heat, moisture, and degradation in aqueous environments. These considerations apply to parenteral, topical, and ophthalmic products rather than to oral preparations.
Regulatory
Where is Polymyxin B Sulfate approved or in use globally?
Polymyxin B Sulfate is reported as approved in the following major regions: US, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Polymyxin B Sulfate right now?
Polymyxin B Sulfate is regulated within the United States and Canada, reflecting established oversight in these markets. Patent‑related considerations are not characterized in the provided context.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Polymyxin B Sulfate procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Polymyxin B Sulfate. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Polymyxin B Sulfate included in the PRO Data Insights coverage?
PRO Data Insights coverage for Polymyxin B Sulfate: 699 verified transactions across 183 suppliers and 162 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Polymyxin B Sulfate?
Market report availability for Polymyxin B Sulfate: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
