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Ceftriaxone | CAS No: 73384-59-5 | GMP-certified suppliers
A medication that treats a broad range of bacterial infections, including respiratory, skin and soft tissue, urinary tract, and ENT infections across key clinical settings.
Therapeutic categories
AmidesAnti-Bacterial AgentsAnti-Infective AgentsAntibacterials for Systemic UseAntiinfectives for Systemic Usebeta Lactam Antibiotics
Generic name
Ceftriaxone
Molecule type
small molecule
CAS number
73384-59-5
DrugBank ID
DB01212
Approval status
Approved drug
ATC code
J01DD04
Primary indications
- Ceftriaxone is used for the treatment of the infections (respiratory, skin, soft tissue, UTI, ENT) caused by susceptible organisms
- Organisms that are generally susceptible to ceftriaxone include S
- Pneumoniae, S
- Pyogenes (group A beta-hemolytic streptococci), coagulase-negative staphylococci, Some Enterobacter spp, H
Product Snapshot
- Ceftriaxone is a parenteral cephalosporin supplied primarily as lyophilized powder or solution for intramuscular or intravenous injection
- It is used for broad-spectrum antibacterial applications across respiratory, skin/soft‑tissue, urinary, and ENT infection segments caused by susceptible organisms
- It is an FDA- and Health Canada–approved product marketed in the US and Canada
Clinical Overview
Ceftriaxone (CAS 73384-59-5) is a third‑generation cephalosporin antibiotic used globally for systemic treatment of bacterial infections caused by susceptible organisms. Clinical use includes respiratory tract infections, skin and soft tissue infections, urinary tract infections, and infections of the ear, nose, and throat. It is also applied in the management of meningitis, gonorrhea, Lyme disease, and other infections where reliable cerebrospinal fluid or tissue penetration is required. Susceptible organisms include Streptococcus pneumoniae, Streptococcus pyogenes, coagulase‑negative staphylococci, Haemophilus influenzae, Neisseria gonorrhoeae, Proteus mirabilis, Escherichia coli, Klebsiella species, Moraxella catarrhalis, Borrelia burgdorferi, and some oral anaerobes.
Pharmacologically, ceftriaxone demonstrates bactericidal activity through inhibition of bacterial cell wall synthesis. Its beta‑lactam structure binds to penicillin‑binding proteins including carboxypeptidases, endopeptidases, and transpeptidases, disrupting peptidoglycan cross‑linking and leading to cell death. The compound shows activity against aerobic gram‑positive and gram‑negative bacteria as well as certain anaerobes. It is resistant to hydrolysis by many penicillinases, cephalosporinases, and some extended‑spectrum beta‑lactamases, although resistance may occur via beta‑lactamase production, altered PBPs, or reduced permeability.
Ceftriaxone exhibits a long elimination half‑life and extensive tissue distribution, including high penetration into cerebrospinal fluid, ocular tissues, and the inner ear. It is eliminated via both renal and biliary pathways. Adverse effects may include gastrointestinal disturbances, hypersensitivity reactions, biliary sludge or pseudolithiasis, and local injection‑site reactions. Concomitant administration with calcium‑containing solutions should be avoided due to risk of precipitation.
Ceftriaxone is widely available globally as sterile injectable formulations. For API procurement, suppliers should demonstrate control of beta‑lactam purity, low levels of related substances, and compliance with regulatory monographs to support consistent manufacturing of parenteral products.
Pharmacologically, ceftriaxone demonstrates bactericidal activity through inhibition of bacterial cell wall synthesis. Its beta‑lactam structure binds to penicillin‑binding proteins including carboxypeptidases, endopeptidases, and transpeptidases, disrupting peptidoglycan cross‑linking and leading to cell death. The compound shows activity against aerobic gram‑positive and gram‑negative bacteria as well as certain anaerobes. It is resistant to hydrolysis by many penicillinases, cephalosporinases, and some extended‑spectrum beta‑lactamases, although resistance may occur via beta‑lactamase production, altered PBPs, or reduced permeability.
Ceftriaxone exhibits a long elimination half‑life and extensive tissue distribution, including high penetration into cerebrospinal fluid, ocular tissues, and the inner ear. It is eliminated via both renal and biliary pathways. Adverse effects may include gastrointestinal disturbances, hypersensitivity reactions, biliary sludge or pseudolithiasis, and local injection‑site reactions. Concomitant administration with calcium‑containing solutions should be avoided due to risk of precipitation.
Ceftriaxone is widely available globally as sterile injectable formulations. For API procurement, suppliers should demonstrate control of beta‑lactam purity, low levels of related substances, and compliance with regulatory monographs to support consistent manufacturing of parenteral products.
Identification & chemistry
| Generic name | Ceftriaxone |
|---|---|
| Molecule type | Small molecule |
| CAS | 73384-59-5 |
| UNII | 75J73V1629 |
| DrugBank ID | DB01212 |
Pharmacology
| Summary | Ceftriaxone is a beta‑lactam antibiotic that inhibits bacterial cell‑wall synthesis by binding to key penicillin‑binding proteins involved in peptidoglycan assembly. This interaction disrupts cell‑wall formation, producing bactericidal effects across a broad range of gram‑positive, gram‑negative, and anaerobic organisms. Its activity is partly maintained by stability against many beta‑lactamases, though resistance can arise through enzyme-mediated hydrolysis, altered PBPs, or reduced permeability. |
|---|---|
| Mechanism of action | Ceftriaxone works by inhibiting the mucopeptide synthesis in the bacterial cell wall.The beta-lactam moiety of ceftriaxone binds to carboxypeptidases, endopeptidases, and transpeptidases in the bacterial cytoplasmic membrane. These enzymes are involved in cell-wall synthesis and cell division. Binding of ceftriaxone to these enzymes causes the enzyme to lose activity; therefore, the bacteria produce defective cell walls, causing cell death. |
| Pharmacodynamics | Ceftriaxone is a cephalosporin/cephamycin beta-lactam antibiotic used in the treatment of bacterial infections caused by susceptible, usually gram-positive, organisms.Ceftriaxone has <i>in vitro</i> activity against gram-positive aerobic, gram-negative aerobic, and anaerobic bacteria.The bactericidal activity of ceftriaxone results from the inhibition of cell wall synthesis and is mediated through ceftriaxone binding to penicillin-binding proteins (PBPs).Ceftriaxone is stable against hydrolysis by a variety of beta-lactamases, including penicillinases, and cephalosporinases and extended-spectrum beta-lactamases.However, resistance to ceftriaxone usually occurs through beta-lactamase hydrolysis, altered PBPs, or reduced bacterial cell permeability.Ceftriaxone should not be mixed with or giving in the same IV line as diluents/products containing calcium as they may cause ceftriaxone to precipitate.Ceftriaxone use may also cause biliary sludge or gallbladder pseudolithiasis. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Penicillin-binding protein 2B | Streptococcus pneumoniae (strain ATCC BAA-255 / R6) | inhibitor |
| Solute carrier family 22 member 11 | Humans | |
| Solute carrier family 22 member 6 | Humans |
ADME / PK
| Absorption | Ceftriaxone is only given as an injection, either intramuscularly or intravenously.Ceftriaxone is less than 1% bioavailable if given orally. |
|---|---|
| Half-life | The elimination half-life of ceftriaxone is 5.8-8.7 hours.The half-life of ceftriaxone in the middle ear fluid has been estimated to be 25 hours. |
| Protein binding | Ceftriaxone is 95% protein bound. |
| Metabolism | Metabolism of ceftriaxone is negligible. |
| Route of elimination | Ceftriaxone is primarily eliminated in the urine (33-67%).The remainder is eliminated through secretion in the bile and removed from the body via the feces. |
| Volume of distribution | The apparent volume of distribution of an intravenous or intramuscular dose in healthy patients is 5.78 to 13.5 L.The volume of distribution of an intravenous or intramuscular dose in septic patients is 6.48 to 35.2 L.Ceftriaxone has good enough CSF penetration to be used as an effective treatment of bacterial meningitis. |
| Clearance | The plasma clearance of ceftriaxone in healthy adults receiving a 0.15-3g dose is 0.58 to 1.45 L/hour.The renal clearance of ceftriaxone is 0.32 to 0.73 L/hour.In intensive care unit patients, ceftriaxone's total drug clearance was 0.96L/h (0.55-1.28 L/h), and unbound drug clearance was 1.91 L/h (1.46-6.20 L/h). |
Formulation & handling
- Parenteral‑only cephalosporin administered as IM or IV formulations, typically supplied as a lyophilized powder requiring reconstitution.
- Aqueous solutions show limited stability and should be prepared close to use; avoid prolonged storage due to hydrolysis sensitivity.
- Highly hydrophilic small molecule with low LogP, enabling reliable dissolution in suitable diluents but requiring attention to pH to maintain solubility and chemical integrity.
Regulatory status
| Lifecycle | Patent protection in the US and Canada is at or near the end of its term, indicating a mature market. As a result, the API is expected to remain in a post‑patent, competition‑established phase in both regions. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Ceftriaxone was originally developed by a single originator company, but the market is now dominated by numerous generic manufacturers and packagers supplying injectable formulations. The product has long been off patent, enabling wide global availability across the US, EU, and other regions. The mature patent status supports extensive existing generic competition and a diversified supply base. |
|---|
Safety
| Toxicity | Ceftriaxone overdose may increase the risk of urolithiasis and subsequent post-renal acute renal failure (PARF).Other symptoms of overdose unavailable in the literature. However, they are likely similar to the adverse effects of the medication. If overdose of ceftriaxone occurs, treat with symptomatic and supportive treatment, as ceftriaxone levels will not be reduced by dialysis. |
|---|
High Level Warnings:
- Excess exposure is associated with urolithiasis and potential post‑renal acute renal failure
- Ceftriaxone concentrations are not measurably reduced by dialysis
- Toxicity manifestations are expected to align with the drug’s known adverse‑effect profile, although detailed overdose symptoms are not well characterized
Ceftriaxone is a type of Cephalosporins
Cephalosporins are a class of pharmaceutical active ingredients (APIs) widely used in the field of antibiotics. They belong to the beta-lactam family, which also includes penicillins. Cephalosporins are derived from a fungus called Acremonium cephalosporium and are known for their potent antimicrobial properties.
These APIs are commonly used to treat a wide range of bacterial infections, including respiratory tract infections, skin and soft tissue infections, urinary tract infections, and even meningitis. Cephalosporins work by inhibiting the synthesis of bacterial cell walls, leading to the disruption of bacterial growth and ultimately their destruction.
Cephalosporins are classified into generations based on their antimicrobial spectrum and activity against specific bacteria. The first-generation cephalosporins are effective against Gram-positive bacteria, while subsequent generations show broader activity against both Gram-positive and Gram-negative bacteria.
Pharmaceutical companies manufacture cephalosporins in various formulations, including tablets, capsules, injectable solutions, and suspensions. They are often prescribed by healthcare professionals and are available under different brand names in the market.
It is important to note that like other antibiotics, cephalosporins should be used judiciously to prevent the development of antibiotic resistance. Proper dosage and adherence to treatment guidelines are crucial to maximize their effectiveness and minimize the risk of resistance.
In conclusion, cephalosporins are a vital category of APIs widely used in the treatment of bacterial infections. Their broad spectrum of activity and effectiveness make them an essential tool in modern medicine.
Ceftriaxone API manufacturers & distributors
Compare qualified Ceftriaxone API suppliers worldwide. We currently have 20 companies offering Ceftriaxone API, with manufacturing taking place in 7 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 | CEP, CoA, FDA, GMP, USDMF | 36 products |
| API Corp. | Producer | Japan | Japan | CoA, JDMF | 11 products |
| Arshine Pharmaceutical Co... | Distributor | China | China | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GDP, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC, WHO-GMP | 176 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| CJ CheilJedang | Producer | South Korea | South Korea | CoA, JDMF | 2 products |
| CSPC Zhongnuo | Producer | China | China | CoA, USDMF | 6 products |
| Daewoong Bio | Producer | South Korea | South Korea | CoA, JDMF | 12 products |
| F Hoffmann-La Roche | Producer | Switzerland | Switzerland | CEP, CoA, FDA | 8 products |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Hanmi Fine Chemical | Producer | South Korea | South Korea | CEP, CoA, GMP, KDMF | 18 products |
| Kopran R.L. | Producer | India | India | CoA, GMP, WC | 8 products |
| Lupin | Producer | India | India | CoA, USDMF | 155 products |
| NCPC Hebei Huamin | Producer | China | China | CoA, JDMF | 4 products |
| Qilu Antibiotics | Producer | China | China | CEP, CoA, FDA, GMP, JDMF, KDMF, USDMF, WC | 33 products |
| Sandoz | Producer | Austria | Unknown | CEP, CoA, FDA, GMP, JDMF, USDMF | 58 products |
| Shandong Lukang | Producer | China | China | CoA, WC | 4 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sichuan Kelun Pharmaceuti... | Producer | China | China | CoA | 6 products |
| Sterile India | Producer | India | India | CoA, ISO9001, USDMF, WC, WHO-GMP | 13 products |
| Suzhou Dawnrays | Producer | China | China | CoA, WC | 1 products |
When sending a request, specify which Ceftriaxone 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 Ceftriaxone 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 Ceftriaxone API
Sourcing
What matters most when sourcing GMP-grade Ceftriaxone?
Key considerations include confirming that the manufacturer complies with GMP requirements accepted in the US and Canada and holds appropriate regulatory documentation for injectable formulations. Given the mature, generic nature of Ceftriaxone, verifying supplier qualifications and consistent batch quality is essential. A diversified global supply base exists, so selecting sources with reliable compliance histories and stable production capacity is important.
Which documents are typically required when sourcing Ceftriaxone API?
Request the core API documentation set: CoA (21 companies), USDMF (8 companies), GMP (8 companies), JDMF (7 companies), CEP (7 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Ceftriaxone API?
Known or reported manufacturers for Ceftriaxone: Xi'an Tian Guangyuan Biotech Co.,Ltd, Aurora Industry Co., Ltd, Arshine Pharmaceutical Co., Limited. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Ceftriaxone 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 Ceftriaxone manufacturers?
Audit reports may be requested for Ceftriaxone: 5 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Ceftriaxone API on Pharmaoffer?
Reported supplier count for Ceftriaxone: 21 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Ceftriaxone API?
Production countries reported for Ceftriaxone: China (10 producers), India (3 producers), South Korea (3 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Ceftriaxone usually hold?
Common certifications for Ceftriaxone suppliers: CoA (21 companies), USDMF (8 companies), GMP (8 companies), JDMF (7 companies), CEP (7 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.
Technical
What is Ceftriaxone (CAS 73384-59-5) used for?
Ceftriaxone is used for systemic treatment of bacterial infections caused by susceptible gram‑positive and gram‑negative organisms. It is applied in respiratory, urinary, skin and soft‑tissue, and ear, nose, and throat infections, as well as in meningitis, gonorrhea, and Lyme disease. Its broad tissue and cerebrospinal fluid penetration supports use in infections requiring reliable distribution to deep tissues or the central nervous system.
Which therapeutic class does Ceftriaxone fall into?
Ceftriaxone belongs to the following therapeutic categories: Amides, Anti-Bacterial Agents, Anti-Infective Agents, Antibacterials for Systemic Use, Antiinfectives for Systemic Use. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Ceftriaxone mainly prescribed for?
The primary indications for Ceftriaxone: Ceftriaxone is used for the treatment of the infections (respiratory, skin, soft tissue, UTI, ENT) caused by susceptible organisms, Organisms that are generally susceptible to Ceftriaxone include S, Pneumoniae, S, Pyogenes (group A beta-hemolytic streptococci), coagulase-negative staphylococci, Some Enterobacter spp, H. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Ceftriaxone work?
Ceftriaxone works by inhibiting the mucopeptide synthesis in the bacterial cell wall.The beta-lactam moiety of Ceftriaxone binds to carboxypeptidases, endopeptidases, and transpeptidases in the bacterial cytoplasmic membrane. These enzymes are involved in cell-wall synthesis and cell division. Binding of Ceftriaxone to these enzymes causes the enzyme to lose activity; therefore, the bacteria produce defective cell walls, causing cell death.
What should someone know about the safety or toxicity profile of Ceftriaxone?
Ceftriaxone’s safety profile includes gastrointestinal disturbances, hypersensitivity reactions, biliary sludge or pseudolithiasis, and local injection‑site reactions. Excess exposure has been associated with urolithiasis and possible post‑renal acute renal failure, and its concentrations are not significantly reduced by dialysis. Overdose manifestations are expected to mirror known adverse effects, although detailed symptoms are not well defined. Concomitant use with calcium‑containing solutions should be avoided due to precipitation risk.
What are important formulation and handling considerations for Ceftriaxone as an API?
Ceftriaxone is formulated as a parenteral-only lyophilized powder that must be reconstituted for IM or IV administration. Aqueous solutions have limited stability and should be prepared close to use to reduce hydrolysis. Its high hydrophilicity supports dissolution in appropriate diluents, but pH control is important to maintain solubility and chemical integrity.
Is Ceftriaxone a small molecule?
Ceftriaxone is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Ceftriaxone?
Ceftriaxone is not formulated for oral use because it is poorly absorbed and its stability in aqueous environments is limited. The drug is supplied as a lyophilized powder for injection, and once reconstituted, solutions are prone to hydrolysis and require prompt use. These same stability limitations would apply to any hypothetical oral aqueous preparation, making it unsuitable for development.
Regulatory
Where is Ceftriaxone approved or in use globally?
Ceftriaxone 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 Ceftriaxone procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Ceftriaxone. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Ceftriaxone included in the PRO Data Insights coverage?
PRO Data Insights coverage for Ceftriaxone: 861 verified transactions across 212 suppliers and 156 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Ceftriaxone?
Market report availability for Ceftriaxone: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.
