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Mupirocin | CAS No: 12650-69-0 | GMP-certified suppliers
A medication that supports effective management of impetigo and secondary skin infections caused by common gram‑positive bacteria, offering reliable topical treatment options for dermatologic needs.
Therapeutic categories
Anti-Bacterial AgentsAnti-Infective AgentsAntibiotics for Topical UseDermatologicalsEnzyme InhibitorsEpoxy Compounds
Generic name
Mupirocin
Molecule type
small molecule
CAS number
12650-69-0
DrugBank ID
DB00410
Approval status
Approved drug, Investigational drug, Vet_approved drug
ATC code
R01AX06
Primary indications
- Indicated for the treatment of impetigo and secondary skin infections, leading to traumatic skin lesions, due to _Staphylococcus aureus_ and _Streptococcus pyogenes_
Product Snapshot
- Topical small‑molecule antibacterial supplied mainly as cutaneous and nasal ointments and creams
- Used for management of impetigo and other secondary skin infections caused by S
- Aureus and S
Clinical Overview
Mupirocin (CAS 12650-69-0) is a topical antibacterial agent used primarily for the management of impetigo and secondary skin infections caused by Staphylococcus aureus and Streptococcus pyogenes. It is also applied intranasally in certain settings to eradicate nasal carriage of staphylococci, particularly S. aureus, when clinically justified. The compound is produced by fermentation of Pseudomonas fluorescens and belongs to the medium-chain fatty acid class, contributing to its distinct structural and pharmacological profile.
Mupirocin acts by selectively inhibiting bacterial isoleucyl‑tRNA synthetase, blocking the formation of isoleucyl‑tRNA and interrupting essential protein synthesis. This mechanism differs from other antibacterial classes and limits cross‑resistance. The agent is bacteriostatic at low concentrations and becomes bactericidal with sustained exposure. Reported minimum bactericidal concentrations are typically multiple folds higher than minimum inhibitory concentrations. Activity is strongest against aerobic gram‑positive cocci, including S. aureus, S. epidermidis, and beta‑hemolytic streptococci.
Systemic absorption from topical application is minimal, and mupirocin is rapidly metabolized to inactive monic acid, which restricts its use to topical and intranasal formulations. No meaningful accumulation is expected. Because systemic exposure is low, systemic adverse effects are uncommon. Local reactions such as burning, stinging, or irritation may occur. Resistance has been documented in both community and healthcare settings, including reports of high resistance prevalence. Known mechanisms include altered target isoleucyl‑tRNA synthetase and plasmid‑mediated acquisition of an alternative enzyme.
Mupirocin is widely recognized under the brand name Bactroban and is approved for human and certain veterinary uses. Formulators and sourcing specialists should ensure that API procurement follows rigorous quality standards, with emphasis on impurity control, confirmation of fermentation‑derived origin, and verification of potency and stereochemical integrity to maintain consistent clinical performance.
Mupirocin acts by selectively inhibiting bacterial isoleucyl‑tRNA synthetase, blocking the formation of isoleucyl‑tRNA and interrupting essential protein synthesis. This mechanism differs from other antibacterial classes and limits cross‑resistance. The agent is bacteriostatic at low concentrations and becomes bactericidal with sustained exposure. Reported minimum bactericidal concentrations are typically multiple folds higher than minimum inhibitory concentrations. Activity is strongest against aerobic gram‑positive cocci, including S. aureus, S. epidermidis, and beta‑hemolytic streptococci.
Systemic absorption from topical application is minimal, and mupirocin is rapidly metabolized to inactive monic acid, which restricts its use to topical and intranasal formulations. No meaningful accumulation is expected. Because systemic exposure is low, systemic adverse effects are uncommon. Local reactions such as burning, stinging, or irritation may occur. Resistance has been documented in both community and healthcare settings, including reports of high resistance prevalence. Known mechanisms include altered target isoleucyl‑tRNA synthetase and plasmid‑mediated acquisition of an alternative enzyme.
Mupirocin is widely recognized under the brand name Bactroban and is approved for human and certain veterinary uses. Formulators and sourcing specialists should ensure that API procurement follows rigorous quality standards, with emphasis on impurity control, confirmation of fermentation‑derived origin, and verification of potency and stereochemical integrity to maintain consistent clinical performance.
Identification & chemistry
| Generic name | Mupirocin |
|---|---|
| Molecule type | Small molecule |
| CAS | 12650-69-0 |
| UNII | D0GX863OA5 |
| DrugBank ID | DB00410 |
Pharmacology
| Summary | Mupirocin inhibits bacterial isoleucyl‑tRNA synthetase, blocking formation of isoleucyl‑tRNA and thereby suppressing protein and RNA synthesis. This leads to bacteriostatic or bactericidal activity depending on exposure duration, with activity primarily against susceptible gram‑positive organisms such as Staphylococcus aureus and Streptococcus pyogenes. Resistance can arise through modified or plasmid‑encoded isoleucyl‑tRNA synthetases. |
|---|---|
| Mechanism of action | Mupirocin specifically and reversibly binds to bacterial isoleucyl transfer-RNA (tRNA) synthetase, which is an enzyme that promotes the conversion of isoleucine and tRNA to isoleucyl-tRNA. Inhibition of this enzyme subsequently leads to the inhibition of the bacterial protein and RNA synthesis.Mupirocin is bacteriostatic at lower concentrations but it exerts bactericidal effects with prolonged exposure, killing 90-99% of susceptible bacteria over a 24 hour period. |
| Pharmacodynamics | Mupirocin is reported to be active against susceptible aerobic gram-positive cocci, such as _Staphylococcus aureus_, _Staphylococcus epidermidis_, and other beta-hemolytic streptococci_Streptococcus pyogenes_.It mediates its antibacterial activity by inhibiting the bacterial protein synthesis and formation of bacterial proteins essential for survival. The minimum bactericidal concentration (MBC) against relevant pathogens is generally eight-fold to thirty-fold higher than the minimum inhibitory concentration (MIC).In one clinical study investigating the therapeutic effectiveness of topical mupirocin in impetigo, the therapeutic response rate was about 94 to 98% after one week following the end of therapy.In clinical studies of patients with primary and secondary skin infections, both elimination of the bacterial pathogen and clinical cure or improvement hav been demonstrated in over 90% of patients receiving topical mupirocin.Mupirocin resistance as high as 81% has been reported previously.Resistance to mupirocin, which occurs more frequently in methicillin-resistant than methicillin-susceptible staphylococci, may occur with the production of a modified isoleucyl-tRNA synthetase, or the acquisition of, by genetic transfer, a plasmid mediating a new isoleucyl-tRNA synthetase. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Isoleucine--tRNA ligase | Staphylococcus aureus | inhibitor |
ADME / PK
| Absorption | Systemic or percutaneous absorption of mupirocin following dermal application is expected to be minimal in adults and children.Occlusive dressings do not significantly enhance drug absorption, but damaged skin may allow enhanced penetration of the drug across the skin barrier. |
|---|---|
| Half-life | In healthy male volunteers, the elimination half-life of mupirocin was about 20 to 40 minutes following intravenous administration. The elimination half-life of monic acid was about 30 to 80 minutes. |
| Protein binding | The protein binding of mupirocin is reported to be over 95%. |
| Metabolism | Following intravenous or oral administration, mupirocin undergoes rapid hepatic metabolism to form the principal metabolite monic acid, which has no antibacterial activity. |
| Route of elimination | Any mupirocin reaching the systemic circulation is rapidly metabolized to form the inactive monic acid, which is eliminated by renal excretion. Following the application of Centany (mupirocin ointment),2% to a 400 cm2 area on the back of 23 healthy volunteers once daily for 7 days, the mean (range) cumulative urinary excretion of monic acid over 24 hrs following the last administration was 1.25% (0.2% to 3.0%) of the administered dose of mupirocin. |
| Volume of distribution | No information available. |
| Clearance | No information available. |
Formulation & handling
- Formulated primarily for topical and nasal delivery due to poor aqueous solubility and unsuitable pharmacokinetics for oral or parenteral use.
- Hydrophobic small‑molecule API with low water solubility, typically requiring ointment or cream bases to ensure adequate dispersion and stability.
- Solid-state stability is generally good, but formulations should limit water content and oxidative stress to preserve potency.
Regulatory status
| Lifecycle | The active ingredient’s U.S. patent expired in 2018, indicating a mature lifecycle with established generic availability. With products marketed in the United States and Canada, the market is stable and largely post‑exclusivity. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Mupirocin was originally developed by a single originator company, with subsequent manufacturing and packaging now distributed across multiple generic producers and repackagers. Branded products such as Bactroban remain established in the US and Canada, but the 2018 expiry of the key US patent has enabled broad generic entry. The current supply landscape reflects mature generic availability with diverse manufacturers supporting stable market presence. |
|---|
Safety
| Toxicity | **LD<sub>50</sub> and Nonclinical Toxicity** The oral LD<sub>50</sub> value in rats is 5000 mg/kg.[MSDS] Studies evaluating the carcinogenic potential of mupirocin have not been performed. In various _in vivo_ animal and _in vitro_ bacterial assays, there was no evidence of genotoxicity caused by mupirocin. In reproduction studies using male and female rats, there were no signs of impaired fertility upon subcutaneous administration of mupirocin. **Use in special populations** Mupirocin was found to be excreted in human milk. As there is limited data on the use of topical mupirocin in pregnant women, the use of this drug in these patients should be undertaken with caution. Based on the findings in clinical trials, topical mupirocin was shown to be safe and effective in pediatric patients aged 2 months to 16 years. |
|---|
High Level Warnings:
- Oral LD50 in rats is approximately 5000 mg/kg, indicating low acute toxicity by this route
- Nonclinical studies showed no evidence of genotoxicity
- Reproductive and fertility studies in rats showed no impairment with subcutaneous exposure
Certificate of Suitability
CEP (also known as COS) is a certificate that proves that qualifies to the relevant monograph of the European Pharmacopoeia. It links the monograph in the Ph.Eur. to the API itself. A CEP is submitted by the manufacturer as part of the market authorization process, and they will become the CEP holder of the document. Being a European certificate, the CEP is granted by the EDQM but is recognized by other countries or institutes such as the FDA in the US. Furthermore, just like the DMF, the data as submitted in the CEP is handled strictly confidential and provides a centralized system recognized by many countries.
Mupirocin 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.
Mupirocin API manufacturers & distributors
Compare qualified Mupirocin API suppliers worldwide. We currently have 9 companies offering Mupirocin API, with manufacturing taking place in 4 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 |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, GMP, MSDS | 229 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, MSDS, USDMF | 176 products |
| Atom Pharma | Producer | India | India | BSE/TSE, CEP, CoA, GMP, MSDS | 14 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 235 products |
| Fishfa Biogenics | Producer | India | India | CoA, ISO14001, ISO9001, WHO-GMP | 5 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Glaxosmithkline | Producer | United Kingdom | United Kingdom | CEP, CoA, GMP | 19 products |
| Hari Ganesh Pharma Privat... | Distributor | India | India | CoA, FDA, GMP | 35 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 762 products |
When sending a request, specify which Mupirocin 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 Mupirocin 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 Mupirocin API
Sourcing
What matters most when sourcing GMP-grade Mupirocin?
When sourcing GMP‑grade Mupirocin for the US or Canadian markets, confirm that the manufacturer complies with applicable GMP and regulatory requirements for these jurisdictions. Clear traceability through the supply chain is important because production and repackaging occur across multiple generic manufacturers. Given the mature generic market, verifying the supplier’s quality systems and documentation practices helps ensure consistency across different sources.
Which documents are typically required when sourcing Mupirocin API?
Request the core API documentation set: CoA (8 companies), GMP (6 companies), MSDS (5 companies), CEP (4 companies), BSE/TSE (3 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Mupirocin API?
Known or reported manufacturers for Mupirocin: Xi'an Tian Guangyuan Biotech Co.,Ltd, Changzhou Comwin Fine Chemicals Co., Ltd, Apino Pharma Co., Ltd., Sinoway industrial Co.,Ltd, Arshine Pharmaceutical Co., Limited, Hari Ganesh Pharma Private Limited. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Mupirocin 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 Mupirocin manufacturers?
Audit reports may be requested for Mupirocin: 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Mupirocin API on Pharmaoffer?
Reported supplier count for Mupirocin: 8 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Mupirocin API?
Production countries reported for Mupirocin: China (5 producers), India (1 producer), United Kingdom (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Mupirocin usually hold?
Common certifications for Mupirocin suppliers: CoA (8 companies), GMP (6 companies), MSDS (5 companies), CEP (4 companies), BSE/TSE (3 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Mupirocin (CAS 12650-69-0) used for?
Mupirocin is used topically to treat impetigo and other superficial skin infections caused by Staphylococcus aureus or Streptococcus pyogenes. It is also applied intranasally in certain settings to eradicate nasal carriage of staphylococci, particularly S. aureus, when clinically justified. Its activity stems from selective inhibition of bacterial isoleucyl‑tRNA synthetase, which blocks essential protein synthesis.
Which therapeutic class does Mupirocin fall into?
Mupirocin belongs to the following therapeutic categories: Anti-Bacterial Agents, Anti-Infective Agents, Antibiotics for Topical Use, Dermatologicals, Enzyme Inhibitors. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Mupirocin mainly prescribed for?
The primary indications for Mupirocin: Indicated for the treatment of impetigo and secondary skin infections, leading to traumatic skin lesions, due to _Staphylococcus aureus_ and _Streptococcus pyogenes_. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Mupirocin work?
Mupirocin specifically and reversibly binds to bacterial isoleucyl transfer-RNA (tRNA) synthetase, which is an enzyme that promotes the conversion of isoleucine and tRNA to isoleucyl-tRNA. Inhibition of this enzyme subsequently leads to the inhibition of the bacterial protein and RNA synthesis.Mupirocin is bacteriostatic at lower concentrations but it exerts bactericidal effects with prolonged exposure, killing 90-99% of susceptible bacteria over a 24 hour period.
What should someone know about the safety or toxicity profile of Mupirocin?
Mupirocin shows low acute toxicity, with an oral LD50 in rats of about 5000 mg/kg, and nonclinical studies have not demonstrated genotoxicity or reproductive impairment. Systemic absorption after topical or intranasal use is minimal, and the drug is rapidly metabolized to inactive monic acid, making systemic adverse effects uncommon. Local reactions such as burning, stinging, or irritation can occur at the application site.
What are important formulation and handling considerations for Mupirocin as an API?
Mupirocin is a hydrophobic, poorly water‑soluble API, so it is typically dispersed in ointment or cream bases that minimize water content and reduce oxidative stress to maintain stability. It is mainly used in topical and nasal formulations because its pharmacokinetics and rapid metabolism make it unsuitable for oral or parenteral products. Damaged skin can increase percutaneous absorption, so formulations and handling should account for potentially higher local penetration. Systemic exposure is generally low, but any absorbed drug is rapidly metabolized to inactive monic acid.
Is Mupirocin a small molecule?
Mupirocin is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Mupirocin?
Oral use of Mupirocin is limited because its poor aqueous solubility and unsuitable pharmacokinetics make stable oral formulations difficult to achieve. As a hydrophobic API, it requires minimal water exposure, since higher water content can compromise dispersion and stability. The molecule should also be protected from oxidative stress to preserve potency. Solid‑state stability is generally good when these conditions are controlled.
Regulatory
Where is Mupirocin approved or in use globally?
Mupirocin 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.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Mupirocin procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Mupirocin. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Mupirocin included in the PRO Data Insights coverage?
PRO Data Insights coverage for Mupirocin: 2012 verified transactions across 479 suppliers and 318 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Mupirocin?
Market report availability for Mupirocin: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
