Cefazolin API Manufacturers & Suppliers
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Cefazolin | CAS No: 25953-19-9 | GMP-certified suppliers
A medication that treats bacterial infections of the skin, respiratory tract, bone, joints, and urinary tract, and is used for surgical infection prevention against Gram-positive bacteria.
Therapeutic categories
Primary indications
- Mainly used to treat bacterial infections of the skin
- It can also be used to treat moderately severe bacterial infections involving the lung, bone, joint, stomach, blood, heart valve, and urinary tract
- It is clinically effective against infections caused by staphylococci and streptococci species of Gram positive bacteria
- May be used for surgical prophylaxis
Product Snapshot
- Cefazolin is an injectable small molecule antibiotic available primarily as a powder for solution for intravenous or intramuscular administration
- It is indicated for the treatment of bacterial infections including skin, respiratory, bone, joint, abdominal, bloodstream, endocarditis, and urinary tract infections, with activity against Gram-positive bacteria such as staphylococci and streptococci
- Cefazolin is approved for use in major regulatory markets including the US and Canada
Clinical Overview
Pharmacologically, cefazolin exerts broad-spectrum antibacterial effects by targeting the synthesis of bacterial cell walls. Its mechanism of action involves binding to penicillin-binding proteins (PBPs) within the bacterial cell wall. This interaction inhibits the final stage of peptidoglycan cross-linking essential for cell wall integrity. The disruption of cell wall synthesis triggers autolytic enzymes such as autolysins, leading to bacterial cell lysis and death.
Following parenteral administration, cefazolin achieves high serum concentrations and is predominantly eliminated through rapid renal excretion. Pharmacokinetic considerations include its activity as both inhibitor and substrate of organic anion transporters OAT1 (SLC22A6) and OAT3 (SLC22A8), which are important in renal drug clearance.
Safety profiles highlight potential nephrotoxicity risks associated with cefazolin, necessitating cautious use in patients with impaired renal function. Monitoring of renal parameters is advisable during therapy. Additionally, hypersensitivity reactions may occur, particularly in individuals with a history of beta-lactam antibiotic allergies.
From a chemical classification standpoint, cefazolin belongs to cephalosporins, characterized by a fused 1,2-thiazine and 2-azetidinone ring system, conferring its beta-lactam activity.
For API sourcing and quality control, attention should be paid to compliance with pharmacopeial standards and verification of purity profiles to ensure consistent clinical performance and safety. Reliable suppliers should provide full documentation of synthetic origin, batch-to-batch consistency, and validated analytical testing aligned with global regulatory expectations.
Identification & chemistry
| Generic name | Cefazolin |
|---|---|
| Molecule type | Small molecule |
| CAS | 25953-19-9 |
| UNII | IHS69L0Y4T |
| DrugBank ID | DB01327 |
Pharmacology
| Summary | Cefazolin is a first-generation cephalosporin antibiotic that exerts bactericidal effects by inhibiting bacterial cell wall synthesis. It targets specific penicillin-binding proteins (PBPs), disrupting peptidoglycan cross-linking and leading to bacterial cell lysis. The compound primarily acts against Gram-positive bacteria and achieves high serum concentrations with renal excretion. |
|---|---|
| Mechanism of action | In vitro tests demonstrate that the bactericidal action of cephalosporins results from inhibition of cell wall synthesis. By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, it inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins. |
| Pharmacodynamics | Cefazolin (also known as cefazoline or cephazolin) is a semi-synthetic first generation cephalosporin for parenteral administration. Cefazolin has broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis. It attains high serum levels and is excreted quickly via the urine. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Penicillin-binding protein 1A | Escherichia coli (strain K12) | inhibitor |
| Penicillin-binding protein 1B | Escherichia coli (strain K12) | inhibitor |
| Penicillin-binding protein 1C | Escherichia coli (strain K12) | inhibitor |
ADME / PK
| Absorption | Not absorbed from GI tract. Must be administered parenterally. Peak serum concentrations attained 1-2 hours post intramuscular injection. |
|---|---|
| Half-life | The serum half-life is approximately 1.8 hours following IV administration and approximately 2.0 hours following IM administration. |
| Protein binding | 74-86% |
| Metabolism | Not metabolized. |
| Route of elimination | Cefazolin is present in very low concentrations in the milk of nursing mothers. Cefazolin is excreted unchanged in the urine. In the first six hours approximately 60% of the drug is excreted in the urine and this increases to 70%-80% within 24 hours. |
Formulation & handling
- Cefazolin is a small molecule antibiotic primarily formulated for intramuscular and intravenous injection.
- The compound is water-soluble and typically supplied as a lyophilized powder for reconstitution prior to parenteral administration.
- Handling requires protection from moisture and light to maintain stability during storage and before use.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) is currently available in both the US and Canadian markets, with patent protection having expired, allowing for generic competition and established market presence. Product availability in these regions reflects a mature lifecycle stage. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Cefazolin has multiple originator companies involved in its manufacturing and packaging, indicating a diversified production base. Its branded products, such as Ancef, have a significant presence primarily in the US and Canadian markets. Patent expirations have led to established generic competition, with numerous generic manufacturers supplying the product. |
|---|
Cefazolin 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.
Cefazolin API manufacturers & distributors
Compare qualified Cefazolin API suppliers worldwide. We currently have 7 companies offering Cefazolin 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 |
|---|---|---|---|---|---|
| ACS Dobfar | Producer | Italy | Italy | CEP, CoA, FDA, GMP, USDMF | 36 products |
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 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 |
| Flavine | Distributor | Germany | Unknown | CoA | 83 products |
| Qilu Antibiotics | Producer | China | China | CEP, CoA, FDA, GMP, USDMF, WC | 33 products |
| Sandoz | Producer | Austria | Unknown | CEP, CoA, FDA, GMP, USDMF | 58 products |
| Shandong Lukang | Producer | China | China | CoA, WC | 4 products |
When sending a request, specify which Cefazolin 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 Cefazolin 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.
