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Cephalexin | CAS No: 15686-71-2 | GMP-certified suppliers
A medication that treats respiratory, skin, bone, ear, and genitourinary infections caused by susceptible bacteria, offering broad antibacterial coverage as a first-generation cephalosporin.
Therapeutic categories
Primary indications
- Cephalexin is indicated for the treatment of certain infections caused by susceptible bacteria
- [Label,L6550,L6553] These infections include respiratory tract infections, otitis media, skin and skin structure infections, bone infections, and genitourinary tract infections
- [Label,L6550,L6553]
Product Snapshot
- Cephalexin is an oral small molecule antibiotic available in various dosage forms including tablets, capsules, suspensions, and powders for suspension or solution
- It is primarily indicated for treatment of bacterial infections such as respiratory tract infections, otitis media, skin and soft tissue infections, bone infections, and genitourinary tract infections
- Cephalexin has approved status for human use in North American regulatory markets including the US FDA and Health Canada
Clinical Overview
Pharmacologically, cephalexin belongs to the class of beta-lactam antibiotics containing a beta-lactam ring fused to a dihydrothiazide moiety. This structural motif confers resistance to degradation by many beta-lactamases, in contrast to penicillins. Cephalexin inhibits the cross-linking of peptidoglycan chains between N-acetylmuramic acid and N-acetylglucosamine in the bacterial cell wall, thereby preventing the formation of the cell wall required for bacterial integrity.
Absorption of cephalexin occurs effectively following oral administration. The drug exhibits limited metabolism and is primarily excreted unchanged via the kidneys through glomerular filtration and tubular secretion. This renal elimination pathway necessitates dose adjustments in patients with impaired renal function to prevent accumulation and toxicity.
Safety considerations focus on its nephrotoxic potential, attributable in part to its interactions with renal transporters such as OAT1, OAT3, and MATE1. Clinically, cephalexin is associated with typical beta-lactam antibiotic adverse effects, including hypersensitivity reactions, gastrointestinal disturbances, and, less commonly, nephrotoxicity. Monitoring is advised in vulnerable populations, particularly those with pre-existing renal impairment.
Cephalexin has FDA approval dating from January 1971 and remains widely used in both outpatient and inpatient settings. Prominent brand names include Keflex, among others, reflecting its long-standing clinical utility.
For API sourcing, strict adherence to pharmacopeial standards is critical to ensure purity and consistent beta-lactam ring integrity. Suppliers should provide comprehensive quality documentation demonstrating compliance with relevant monographs and absence of degradants, given cephalexin’s susceptibility to hydrolysis and the critical nature of maintaining its beta-lactam structure for clinical efficacy.
Identification & chemistry
| Generic name | Cephalexin |
|---|---|
| Molecule type | Small molecule |
| CAS | 15686-71-2 |
| UNII | 5SFF1W6677 |
| DrugBank ID | DB00567 |
Pharmacology
| Summary | Cephalexin is a first-generation cephalosporin antibiotic that targets multiple penicillin-binding proteins involved in bacterial cell wall synthesis. Its mechanism involves inhibiting the cross-linking of peptidoglycan chains, leading to cell wall disruption and bacterial cell death. It demonstrates activity primarily against gram-positive bacteria and is used in the treatment of various infections caused by susceptible organisms. |
|---|---|
| Mechanism of action | Cephalexin is a first generation cephalosporin antibiotic. Cephalosporins contain a beta lactam and dihydrothiazide. Unlike penicillins, cephalosprins are more resistant to the action of beta lactamase. Cephalexin inhibits bacterial cell wall synthesis, leading breakdown and eventualy cell death. |
| Pharmacodynamics | Cephalexin (also called Cefalexin) is a first generation cephalosporin antibiotic. It is one of the most widely prescribed antibiotics, often used for the treatment of superficial infections that result as complications of minor wounds or lacerations. It is effective against most gram-positive bacteria through its inihibition of the cross linking reaction between N-acetyl muramicacid and N-acetylglucosamine in the cell wall, leading to cell lysis. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Penicillin-binding protein 3 | Streptococcus pneumoniae | inhibitor |
| Penicillin-binding protein 2a | Streptococcus pneumoniae (strain ATCC BAA-255 / R6) | inhibitor |
| Penicillin-binding protein 1b | Streptococcus pneumoniae (strain ATCC BAA-255 / R6) | inhibitor |
ADME / PK
| Absorption | Well absorbed from the upper gastrointestinal tract with nearly 100% oral bioavailability. Cephalexin is not absorbed in the stomach but is absorbed in the upper intestine. Patients taking 250mg of cephalexin reach a maximum plasma concentration of 7.7mcg/mL and patients taking 500mg reach 12.3mcg/mL. |
|---|---|
| Half-life | The half life of cephalexin is 49.5 minutes in a fasted state and 76.5 minutes with food though these times were not significantly different in the study. |
| Protein binding | Cephalexin is 10-15% bound to serum proteins[Label,L6550] including serum albumin. |
| Metabolism | Cephalexin is not metabolized in the body.[A179029,Label,L6550,L6553] |
| Route of elimination | Cephalexin is over 90% excreted in the urine after 6 hours by glomerular filtration and tubular secretion[Label,L6550,L6553] with a mean urinary recovery of 99.3%. Cephalexin is unchanged in the urine. |
| Volume of distribution | 5.2-5.8L. |
| Clearance | Clearance from one subject was 376mL/min. |
Formulation & handling
- Cephalexin is a small molecule antibiotic formulated exclusively for oral administration in multiple solid and liquid dosage forms.
- It is not a peptide or biologic and demonstrates moderate water solubility with a low logP value, indicating hydrophilic properties.
- Formulations are stable for standard handling and storage conditions, and the API can be taken with or without food without affecting absorption.
Regulatory status
| Lifecycle | The API’s primary patents have expired in both Canada and the US, allowing for generic competition and broadly established market availability. As a result, the product is considered to be at a mature stage in its lifecycle within these markets. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Cephalexin is produced by multiple manufacturers, including several originator and generic pharmaceutical companies with a significant presence in North America. Branded versions are primarily marketed in the US and Canada, with multiple brand samples available, indicating established market penetration in these regions. Patent expiration has allowed for extensive generic competition, as evidenced by the broad array of manufacturers and packagers involved in the supply chain. |
|---|
Safety
| Toxicity | Symptoms of overdose include blood in the urine, diarrhea, nausea, upper abdominal pain, and vomiting. An overdose is generally managed through supportive treatment as diuresis, dialysis, hemodialysis, and charcoal hemoperfusion are not well studied in this case. The oral median lethal dose of cephalexin in rats is >5000 mg/kg. The oral LD50 in a monkey is >1g/kg and the lowest dose causing a toxic effect in humans is 14mg/kg.[MSDS] Cephalexin has not been shown to be harmful in pregnancy and is not associated with teratogeniticy. Cephalexin is present in breast milk, though infants may be exposed to <1% of the dose given to the mother. The effects of breast milk exposure to cephalexin have not been established and so caution must be exercised and the risk and benefit of cephalexin use in breastfeeding must be weighed. Cephalexin has not been studied for carcinogenicity or mutagenicity. Cephalexin has no affect on fertility in rats. |
|---|
- Overdose symptoms may include hematuria, gastrointestinal distress, and abdominal pain
- Management is primarily supportive as extracorporeal removal methods lack established efficacy
- Oral median lethal doses exceed 5000 mg/kg in rodents and 1 g/kg in primates, with toxic effects in humans observed at doses ≥14 mg/kg
Cephalexin 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.
Cephalexin API manufacturers & distributors
Compare qualified Cephalexin API suppliers worldwide. We currently have 11 companies offering Cephalexin 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 |
| Antibióticos De León | Producer | Spain | Spain | CEP, CoA, FDA, GMP, USDMF | 3 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 |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Lupin | Producer | India | India | CEP, CoA, FDA, GMP, USDMF, WC | 155 products |
| Ranbaxy Laboratories | Producer | India | India | CEP, CoA, GMP | 7 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sun Pharma | Producer | India | India | CoA, USDMF | 219 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 140 products |
| Yungjin Pharmaceutical | Producer | South Korea | South Korea | CoA, JDMF | 10 products |
When sending a request, specify which Cephalexin 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.).
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