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Vancomycin | CAS No: 1404-90-6 | GMP-certified suppliers
A medication that treats severe Gram‑positive bloodstream, cardiac, skin, bone, and respiratory infections, and provides targeted therapy for C. difficile–associated gastrointestinal disease.
Therapeutic categories
Primary indications
- Administered intravenously, vancomycin is indicated in adult and pediatric patients for the treatment of septicemia, infective endocarditis, skin and skin structure infections, bone infections, and lower respiratory tract infections
- Administered orally, vancomycin is indicated in adult and pediatric patients for the treatment of _Clostridium difficile_-associated diarrhea and for enterocolitis caused by _Staphylococcus aureus_ (including methicillin-resistant strains)
Product Snapshot
- Vancomycin is supplied as an injectable small-molecule glycopeptide and as an oral formulation for local GI action
- It is used for severe Gram-positive infections including septicemia, endocarditis, skin and soft tissue infections, bone infections, lower respiratory infections, and for C
- Difficile–associated diarrhea and S
Clinical Overview
Vancomycin exhibits concentration‑dependent bactericidal activity against susceptible Gram‑positive organisms. It retains activity against Listeria monocytogenes, Streptococcus pyogenes, Streptococcus pneumoniae including penicillin‑resistant strains, Streptococcus agalactiae, Actinomyces species, and Lactobacillus species. In vitro synergy with aminoglycosides has been documented against certain staphylococci, enterococci, and viridans group streptococci. It has no activity against Gram‑negative bacilli, mycobacteria, or fungi.
The mechanism of action involves inhibition of bacterial cell‑wall biosynthesis through high‑affinity binding to terminal D‑alanyl‑D‑alanine residues on peptidoglycan precursors. This prevents incorporation of N‑acetylmuramic acid and N‑acetylglucosamine peptide subunits into the maturing cell wall. Additional effects include altered membrane permeability and interference with RNA synthesis. Cross‑resistance with unrelated antibiotic classes has not been observed.
Absorption following oral dosing is minimal, limiting systemic exposure. Intravenous administration results in renal elimination as the primary clearance pathway, and the drug exhibits a narrow therapeutic index. Nephrotoxicity and ototoxicity are established risks, particularly with elevated serum concentrations, prolonged therapy, or concomitant nephrotoxic agents. Therapeutic drug monitoring is commonly required to maintain appropriate exposure.
For API procurement, sourcing should emphasize control of glycopeptide heterogeneity, compliance with pharmacopeial specifications, and robust impurity and potency characterization to support parenteral and oral formulation development.
Identification & chemistry
| Generic name | Vancomycin |
|---|---|
| Molecule type | Small molecule |
| CAS | 1404-90-6 |
| UNII | 6Q205EH1VU |
| DrugBank ID | DB00512 |
Pharmacology
| Summary | Vancomycin is a glycopeptide antibiotic that exerts bactericidal activity by binding the D‑Ala‑D‑Ala termini of peptidoglycan precursors, blocking their incorporation into the Gram‑positive cell‑wall matrix. This disrupts cell‑wall biosynthesis and also alters membrane permeability and RNA synthesis. Its pharmacodynamic profile is characterized by activity against a broad range of Gram‑positive organisms, including resistant strains. |
|---|---|
| Mechanism of action | The bactericidal action of vancomycin results primarily from inhibition of cell-wall biosynthesis. Specifically, vancomycin prevents incorporation of N-acetylmuramic acid (NAM)- and N-acetylglucosamine (NAG)-peptide subunits from being incorporated into the peptidoglycan matrix, which forms the major structural component of Gram-positive cell walls. Vancomycin forms hydrogen bonds with the terminal D-alanyl-D-alanine moieties of the NAM/NAG-peptides, preventing the incorporation of the NAM/NAG-peptide subunits into the peptidoglycan matrix. In addition, vancomycin alters bacterial-cell-membrane permeability and RNA synthesis. There is no cross-resistance between vancomycin and other antibiotics. Vancomycin is not active in vitro against gram-negative bacilli, mycobacteria, or fungi. [FDA Label] |
| Pharmacodynamics | Vancomycin is a branched tricyclic glycosylated nonribosomal peptide often reserved as the "drug of last resort", used only after treatment with other antibiotics has failed. Vancomycin has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections: <i>Listeria monocytogenes</i>, <i>Streptococcus pyogenes</i>, <i>Streptococcus pneumoniae</i> (including penicillin-resistant strains), <i>Streptococcus agalactiae</i>, <i>Actinomyces</i> species, and <i>Lactobacillus</i> species. The combination of vancomycin and an aminoglycoside acts synergistically in vitro against many strains of Staphylococcus aureus, Streptococcus bovis, enterococci, and the viridans group streptococci [FDA Label]. |
Targets
| Target | Organism | Actions |
|---|---|---|
| D-Ala-D-Ala moiety of NAM/NAG peptide subunits of peptidoglycan | Gram-positive Bacteria | ligand |
ADME / PK
| Absorption | Poorly absorbed from gastrointestinal tract, however systemic absorption (up to 60%) may occur following intraperitoneal administration [FDA Label]. |
|---|---|
| Half-life | Half-life in normal renal patients is approximately 6 hours (range 4 to 11 hours). In anephric patients, the average half-life of elimination is 7.5 days [FDA Label]. |
| Protein binding | Approximately 50% serum protein bound . |
| Metabolism | Since almost 75-80% of the drug is excreted unchanged in the urine after the first 24 hours following administration, there is seemingly no apparent metabolism of the drug [FDA Label, A31723]. The concentration of vancomycin in the liver tissue and bile 24 hours after administration has also been reported at or below detection limits as well . |
| Route of elimination | In the first 24 hours, about 75-80% of an administered dose of vancomycin is excreted in urine by glomerular filtration [FDA Label, A31723]. |
| Volume of distribution | The volume of distribution, as discussed in the literature, varies between 0.4-1 L/kg . |
| Clearance | The mean plasma clearance of vancomycin is about 0.058 L/kg/h [FDA Label]. |
Formulation & handling
- Vancomycin is a large cyclic‑peptide small molecule with poor membrane permeability, supporting parenteral use for systemic delivery and oral use only for localized GI action.
- Low LogP and limited aqueous solubility require reconstitution/solubilization considerations for injectable products, with lyophilized formats common to enhance stability.
- The molecule shows good chemical stability in solid form but solutions require controlled pH and appropriate diluents to minimize degradation and precipitation during handling.
Regulatory status
| Lifecycle | The API remains in an early‑to‑mid lifecycle stage, with multiple U.S. patents expiring in 2035. With current marketing limited to the US and Canada, the market is expected to stay protected in these regions until patent expiry. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Vancomycin is supplied by multiple established manufacturers and packagers, indicating a mature production base with no single dominant originator in current commercial distribution. Branded formulations such as Firvanq are marketed mainly in the United States and Canada, while the active ingredient itself is widely established globally. Although several U.S. formulation patents extend to 2035, the core vancomycin molecule is long off patent, so generic competition is already well‑established. |
|---|
Safety
| Toxicity | The oral LD<sub>50</sub> in mice is 5000 mg/kg. The median lethal intravenous dose is 319 mg/kg in rats and 400 mg/kg in mice. [FDA Label] Conversely, the most common adverse effects associated with vancomycin appear to be nausea, abdominal pain, and hypokalemia [FDA Label]. In particular, incidences of hypokalemia, urinary tracy infection, peripheral edema, insomnia, constipation, anemia, depression, vomiting, and hypotension are higher among subjects >65 years of than in those that are 65 years old or younger [FDA Label]. Additionally, nephrotoxicity involving reports of renal failure, renal impairment, elevated blood creatinine, and others has also occurred with vancomycin therapy during studies, and can occur during or after completion of a course of therapy [FDA Label]. Risk of such nephrotoxicity is increased in patients greater than 65 years of age [FDA Label]. Ototoxicity has also occurred in patients receiving vancomycin treatment, and it can be transient or permanent. This effect has been reported primarily in patients who have been given excessive intravenous doses, who have kidney dysfunction, who have an underlying hearing loss, or who are receiving concomitant therapy with another ototoxic agent like an aminoglycoside [FDA Label]. Potentially related adverse effects like vertigo, dizziness, and tinnitus have also been reported [FDA Label]. Neutropenia, often beginning one week or more after onset of intravenous vancomycin therapy or after a total dose of more than 25 mg has been observed for several dozen patients as well. This neutropenia however, appears to be promptly reversible when the vancomycin treatment is discontinued. Alternatively, thrombocytopenia has also been reported [FDA Label]. Additionally, a condition has been reported that is described as being similar to IV-induced symptoms involving symptoms consistent with anaphylactoid reactions, including hypotension, wheezing, dyspnea, urticaria, pruritus, flushing of the upper body (in what is known as the so-called 'Red Man Syndrome'), pain and muscle spasm of the chest and back. Although on average such reactions usually resolve within 20 minutes, they are just as likely to persist for hours [FDA Label, A760]. In a controlled clinical study, the potential ototoxic and nephrotoxic effects of vancomycin on infants were assessed when the drug was given intravenously to pregnant women for serious staphylococcal infections complicating intravenous drug abuse. The results obtained demonstrated that vancomycin was found in cord blood but that no sensorineural hearing loss or nephrotoxicity attributable to vancomycin was noted. Ultimately however, because the number of subjects treated in this study was limited and vancomycin was administered only in the second and third trimesters, it is not formally known whether vancomycin causes fetal harm. Subsequently, vancomycin should be given to a pregnant woman only if clearly needed [FDA Label]. Although it is known that vancomycin is excreted in human milk based on information obtained from the intravenous administration of the medication, it is not known if vancomycin is excreted into human milk after oral administration. However, because of the overall potential for adverse events, caution must be exercised when vancomycin is given to a nursing woman and a decision must be made whether to discontinue nursing or discontinue the drug, taking into consideration the importance of the drug to the mother [FDA Label]. The safety and effectiveness in pediatric patients have not been formally established [FDA Label]. Patients older than 65 years of age may take longer to respond to therapy compared to patients aged 65 year or younger. Vancomycin treatment in patients aged older than 65 years subsequently should not be discontinued or switched to an alternative treatment prematurely [FDA Label]. Furthermore, clinical studies have demonstrated that geriatric patients are at increased risk of developing nephrotoxicity following treatment with oral vancomycin, which can occur during or after completion of therapy. In patients aged older than 65 years, including those with normal renal function prior to treatment, renal function should be monitored during and following treatment with vancomycin to detect any potential vancomycin induced nephrotoxicity [FDA Label]. |
|---|
- High parenteral toxicity is noted, with median lethal intravenous doses of 319 mg/kg in rats and 400 mg/kg in mice
- Nephrotoxicity and ototoxicity are documented risks, especially with elevated exposure or concurrent renal impairment
- Adverse effect profile includes gastrointestinal disturbances, electrolyte imbalance (notably hypokalemia), infusion‑related reactions such as upper‑body flushing, and hematologic effects including neutropenia and thrombocytopenia
Vancomycin is a type of Glycopeptides
Glycopeptides are a subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in the field of medicinal chemistry and drug development. These complex molecules consist of a peptide chain with one or more attached carbohydrate chains, known as glycans.
Glycopeptides possess unique chemical and structural properties that contribute to their diverse biological activities. They are primarily recognized for their potent antimicrobial properties and are commonly used to combat various bacterial infections, including methicillin-resistant Staphylococcus aureus (MRSA) and other multidrug-resistant strains. This makes them highly valuable in the pharmaceutical industry.
The glycan moieties present in glycopeptides contribute to their mode of action. These carbohydrates aid in the recognition and binding of the glycopeptides to specific bacterial targets, inhibiting cell wall synthesis and disrupting bacterial growth. This mechanism of action sets glycopeptides apart from other classes of antibiotics, making them effective against resistant bacterial strains.
Glycopeptides can be produced through synthetic or semi-synthetic methods, with natural sources such as soil bacteria serving as starting materials. Vancomycin and teicoplanin are examples of well-known glycopeptide antibiotics. Researchers continue to explore the potential of glycopeptides in areas beyond antimicrobial applications, including cancer therapy and drug delivery systems.
In summary, glycopeptides represent a vital subcategory of pharmaceutical APIs with exceptional antimicrobial properties and significant potential in various therapeutic applications. Their complex structure and unique mechanism of action make them valuable assets in the fight against drug-resistant bacteria and other diseases.
Vancomycin (Glycopeptides), classified under 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.
Vancomycin API manufacturers & distributors
Compare qualified Vancomycin API suppliers worldwide. We currently have 14 companies offering Vancomycin API, with manufacturing taking place in 5 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 |
|---|---|---|---|---|---|
| ACS Dobfar | Producer | Italy | Italy | CoA, USDMF | 36 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF | 176 products |
| CKD Bio | Producer | South Korea | South Korea | CEP, CoA, GMP, USDMF | 12 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Lek Pharma | Producer | Slovenia | Unknown | CEP, CoA, GMP, JDMF, USDMF | 32 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Menovo | Producer | China | China | CoA, WC | 27 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 762 products |
| Socosur | Distributor | France | Unknown | CoA | 21 products |
| Xellia | Producer | Denmark | Unknown | CEP, CoA, FDA, GMP, USDMF | 9 products |
| Zhejiang Changming | Producer | China | China | CoA, WC | 19 products |
| Zhejiang Guobang | Producer | China | China | CoA, WC | 6 products |
| Zhejiang Hengkang Pharmac... | Producer | China | China | BSE/TSE, CoA, JDMF, MSDS, USDMF, WC | 31 products |
When sending a request, specify which Vancomycin 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 Vancomycin 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 Vancomycin API
Sourcing
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Technical
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Regulatory
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