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Fusidic acid | CAS No: 6990-06-3 | GMP-certified suppliers
A medication that supports the treatment of bacterial infections, offering reliable antibacterial coverage for dermatologic, ophthalmic, and systemic needs across key markets.
Therapeutic categories
Agents Causing Muscle ToxicityAnti-Bacterial AgentsAnti-Infective AgentsAntibacterials for Systemic UseAntibiotics for Topical UseAntiinfectives for Systemic Use
Generic name
Fusidic acid
Molecule type
small molecule
CAS number
6990-06-3
DrugBank ID
DB02703
Approval status
Approved drug, Investigational drug
ATC code
S01AA13
Primary indications
- For the treatment of bacterial infections
Product Snapshot
- Fusidic acid is a small‑molecule antibiotic supplied mainly in topical, ophthalmic, oral, and occasional intravenous formulations
- It is used for the management of bacterial infections in dermatologic and ophthalmic settings
- It holds approved status in the US and Canada with certain presentations remaining investigational
Clinical Overview
Fusidic acid (CAS 6990-06-3) is a steroidal antibacterial agent obtained from the fermentation of Fusidium coccineum. It is used for the treatment of bacterial infections and is available in topical formulations such as dermatologic creams and ophthalmic preparations, as well as systemic forms including tablets and parenteral products. Clinical use focuses on infections caused by susceptible gram‑positive organisms, particularly staphylococci.
The compound exhibits bacteriostatic activity. Its pharmacologic effect is achieved by inhibiting bacterial protein synthesis. Fusidic acid binds to elongation factor G and prevents its translocation from the ribosome, interrupting the elongation step of protein synthesis. Additional inhibition of chloramphenicol acetyltransferase has been described. The drug belongs to the chemical class of steroid esters, characterized by a steroid nucleus bearing a carboxylic acid ester group.
Absorption after oral administration is moderate and may be influenced by formulation. Protein binding is high, which affects distribution and free‑drug levels. Metabolism occurs primarily in the liver, and elimination is mainly biliary, with limited renal clearance. These pathways contribute to potential interactions, as fusidic acid is reported to interact with several transporters and metabolic enzymes, including CYP3A and CYP2D6, and to act as an inhibitor or substrate in various systems.
Systemic use requires attention to hepatic function and the potential for drug–drug interactions. Muscle toxicity has been reported, particularly when used with agents associated with myopathy risk. Topical and ophthalmic products demonstrate low systemic exposure, but hypersensitivity or local irritation can occur. Systemic therapy is generally reserved for infections requiring targeted coverage when alternative options are limited.
Fusidic acid is available globally in branded and generic topical products and in systemic formulations in certain regions. For API procurement, manufacturers should verify material identity, control stereochemical integrity, and ensure compliance with relevant monographs and impurity specifications, with particular focus on microbial limits and residual solvent control.
The compound exhibits bacteriostatic activity. Its pharmacologic effect is achieved by inhibiting bacterial protein synthesis. Fusidic acid binds to elongation factor G and prevents its translocation from the ribosome, interrupting the elongation step of protein synthesis. Additional inhibition of chloramphenicol acetyltransferase has been described. The drug belongs to the chemical class of steroid esters, characterized by a steroid nucleus bearing a carboxylic acid ester group.
Absorption after oral administration is moderate and may be influenced by formulation. Protein binding is high, which affects distribution and free‑drug levels. Metabolism occurs primarily in the liver, and elimination is mainly biliary, with limited renal clearance. These pathways contribute to potential interactions, as fusidic acid is reported to interact with several transporters and metabolic enzymes, including CYP3A and CYP2D6, and to act as an inhibitor or substrate in various systems.
Systemic use requires attention to hepatic function and the potential for drug–drug interactions. Muscle toxicity has been reported, particularly when used with agents associated with myopathy risk. Topical and ophthalmic products demonstrate low systemic exposure, but hypersensitivity or local irritation can occur. Systemic therapy is generally reserved for infections requiring targeted coverage when alternative options are limited.
Fusidic acid is available globally in branded and generic topical products and in systemic formulations in certain regions. For API procurement, manufacturers should verify material identity, control stereochemical integrity, and ensure compliance with relevant monographs and impurity specifications, with particular focus on microbial limits and residual solvent control.
Identification & chemistry
| Generic name | Fusidic acid |
|---|---|
| Molecule type | Small molecule |
| CAS | 6990-06-3 |
| UNII | 59XE10C19C |
| DrugBank ID | DB02703 |
Pharmacology
| Summary | Fusidic acid is a bacteriostatic antibiotic that targets bacterial protein synthesis by blocking the translocation activity of elongation factor G on the ribosome. It can also inhibit chloramphenicol acetyltransferase enzymes, further limiting bacterial survival. These actions suppress bacterial growth in infections caused by susceptible organisms. |
|---|---|
| Mechanism of action | Fusidic acid works by interfering with bacterial protein synthesis, specifically by preventing the translocation of the elongation factor G (EF-G) from the ribosome. It also can inhibit chloramphenicol acetyltransferase enzymes. |
| Pharmacodynamics | Fusidic acid is a bacteriostatic antibiotic and helps prevent bacterial growth while the immune system clears the infection. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Elongation factor G | Thermus thermophilus | inhibitor |
| Chloramphenicol acetyltransferase | Salmonella typhi | inhibitor |
| Chloramphenicol acetyltransferase 3 | Escherichia coli | inhibitor |
ADME / PK
| Absorption | Sodium fusidic acid tablets have a 91% oral bioavailability. Absorption of the film-coated tablets is complete when compared to a solution, however oral absorption is variable. Oral fusidic acid hemihydrate (suspension) achieved a 22.5% bioavailability in pediatric patients following a 20 milligram/kilogram dose. |
|---|---|
| Half-life | Approximately 5 to 6 hours in adults. |
| Protein binding | 97 to 99% |
| Metabolism | Metabolites include dicarboxylic ester/acid, 3-keto fusidic acid, hydroxy fusidic acid, glucuronide fusidic acid and a glycol metabolite. |
Formulation & handling
- Fusidic acid is a lipophilic small‑molecule steroidal antibiotic with very low aqueous solubility, favoring topical, ophthalmic, and suspension-based oral formulations.
- Oral products typically use suspended API or solid dosage forms with surfactants/wetting agents to manage poor solubility and food can reduce GI irritation.
- IV and ophthalmic solutions require solubilizers or salt/complex forms to achieve workable concentrations due to limited water solubility and stability constraints.
Regulatory status
| Lifecycle | The API is marketed in the United States and Canada, where key patents have expired or are nearing expiry, indicating a transition toward a mature market phase. These conditions typically support increased generic competition and stable but limited growth potential. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Fusidic acid is an established antibacterial API originally developed by a single originator company and is now supplied by multiple manufacturers. Branded products are available in several regions, including Canada, the US, and other international markets under long‑standing brand names. Patents expired many years ago, so the molecule commonly faces existing generic competition in most jurisdictions. |
|---|
Fusidic Acid 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.
Fusidic Acid API manufacturers & distributors
Compare qualified Fusidic Acid API suppliers worldwide. We currently have 7 companies offering Fusidic Acid 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 |
|---|---|---|---|---|---|
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 250 products |
| Azelis | Producer | Germany | Germany | CEP, CoA, GMP | 4 products |
| Joyang Labs. | Producer | China | China | CEP, CoA, FDA, GMP, USDMF | 2 products |
| Leo Pharma | Producer | Denmark | Denmark | CEP, CoA, GMP, JDMF | 5 products |
| Ojsc Biosintez | Producer | Russia | Russia | CEP, CoA | 1 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF, WC | 757 products |
When sending a request, specify which Fusidic Acid 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 Fusidic Acid 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 Fusidic Acid API
Sourcing
What matters most when sourcing GMP-grade Fusidic Acid?
Key considerations include confirming GMP compliance and ensuring the manufacturer can provide complete regulatory documentation suitable for Canada and the US. It is also important to verify the supplier’s experience with this established antibacterial API and their ability to support ongoing quality and consistency. Given the presence of multiple manufacturers, assessing supply reliability and batch-to-batch reproducibility is essential.
Which documents are typically required when sourcing Fusidic Acid API?
Request the core API documentation set: CoA (7 companies), CEP (6 companies), GMP (6 companies), USDMF (3 companies), FDA (2 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Fusidic Acid API?
Known or reported manufacturers for Fusidic Acid: Aurora Industry Co., Ltd, SETV Global, Sinoway industrial Co.,Ltd. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Fusidic Acid 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 Fusidic Acid manufacturers?
Audit reports may be requested for Fusidic Acid: 0 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Fusidic Acid API on Pharmaoffer?
Reported supplier count for Fusidic Acid: 7 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Fusidic Acid API?
Production countries reported for Fusidic Acid: China (3 producers), India (1 producer), Denmark (1 producer). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Fusidic Acid usually hold?
Common certifications for Fusidic Acid suppliers: CoA (7 companies), CEP (6 companies), GMP (6 companies), USDMF (3 companies), FDA (2 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Fusidic Acid (CAS 6990-06-3) used for?
Fusidic Acid is used to treat infections caused by susceptible gram‑positive bacteria, particularly staphylococci. It is available in topical dermatologic and ophthalmic products and in some regions as systemic formulations such as tablets or parenteral preparations. Systemic use is generally reserved for infections requiring targeted coverage when other options are limited.
Which therapeutic class does Fusidic Acid fall into?
Fusidic Acid belongs to the following therapeutic categories: Agents Causing Muscle Toxicity, Anti-Bacterial Agents, Anti-Infective Agents, Antibacterials for Systemic Use, Antibiotics for Topical Use. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Fusidic Acid mainly prescribed for?
The primary indications for Fusidic Acid: For the treatment of bacterial infections. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Fusidic Acid work?
Fusidic Acid works by interfering with bacterial protein synthesis, specifically by preventing the translocation of the elongation factor G (EF-G) from the ribosome. It also can inhibit chloramphenicol acetyltransferase enzymes.
What should someone know about the safety or toxicity profile of Fusidic Acid?
Systemic Fusidic Acid can affect hepatic function and has a notable potential for drug–drug interactions because it involves CYP3A, CYP2D6, and various transporters. Muscle toxicity, including myopathy risk, has been reported, especially when combined with other agents associated with muscle injury. Topical and ophthalmic use produces low systemic exposure but may cause local irritation or hypersensitivity. Monitoring is recommended when systemic therapy is used.
What are important formulation and handling considerations for Fusidic Acid as an API?
Fusidic Acid’s very low aqueous solubility requires use of suspensions, surfactants, or wetting agents in oral and topical formulations to ensure adequate dispersion. Its lipophilic, steroidal structure supports topical and ophthalmic products, while injectable or ophthalmic solutions generally need solubilizers or salt/complex forms to reach usable concentrations. Food can help reduce gastrointestinal irritation with oral products. High protein binding and multiple metabolites do not usually drive excipient selection but should be considered when assessing formulation changes that may affect absorption.
Is Fusidic Acid a small molecule?
Fusidic Acid is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Fusidic Acid?
Oral Fusidic Acid is limited by its very low aqueous solubility, so formulations rely on suspensions or solid dosage forms with surfactants or wetting agents to maintain physical stability. Ensuring uniform dispersion in suspensions and preventing precipitation in solids are typical considerations. Food may be used to reduce gastrointestinal irritation but does not address solubility‑driven stability constraints.
Regulatory
Where is Fusidic Acid approved or in use globally?
Fusidic Acid is reported as approved in the following major regions: Canada, US. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.
What’s the regulatory and patent landscape for Fusidic Acid right now?
In Canada and the United States, the regulatory framework for Fusidic Acid is defined by national drug authorities that evaluate quality, safety, and compliance requirements for active pharmaceutical ingredients. The patent landscape is determined by any existing compound, formulation, or process patents and their respective expiration timelines. Developers must ensure regulatory alignment and verify freedom‑to‑operate based on applicable patent protections within these jurisdictions.
Pharmaoffer
How does Pharmaoffer’s Smart Sourcing Service help with Fusidic Acid procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Fusidic Acid. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Fusidic Acid included in the PRO Data Insights coverage?
PRO Data Insights coverage for Fusidic Acid: 1866 verified transactions across 431 suppliers and 275 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Fusidic Acid?
Market report availability for Fusidic Acid: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
