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Cefdinir | CAS No: 91832-40-5 | GMP-certified suppliers
A medication that treats acute bacterial infections in respiratory, ear, nose, throat, and skin areas, including otitis media, sinusitis, pneumonia, bronchitis, pharyngitis, tonsillitis, and skin infections.
Therapeutic categories
Primary indications
- Cefdinir is indicated to treat acute bacterial otitis media, acute maxillary sinusitis, community-acquired (CA) pneumonia, acute bacterial exacerbations of chronic bronchitis, pharyngitis/tonsillitis, and uncomplicated skin and skin structure infections in children and adults
- The organisms susceptible to cefdinir have been listed below in addition to their associated clinical condition that may be treated with cefdinir
- Various beta-lactamase producing organisms may be treated, as indicated in certain sections below
Product Snapshot
- Cefdinir is an oral small molecule antibiotic available in various formulations including tablets, capsules, suspensions, and powders for suspension
- It is primarily used to treat respiratory tract infections, acute bacterial otitis media, pharyngitis/tonsillitis, maxillary sinusitis, and uncomplicated skin and skin structure infections
- Cefdinir is approved for use in the US market
Clinical Overview
Pharmacologically, cefdinir exerts bactericidal activity by inhibiting bacterial cell wall synthesis. Its chemical structure features a six-member dihydrothiazine ring, which differentiates it from penicillins and contributes to enhanced resistance against beta-lactamase enzymatic degradation. Cefdinir binds with high affinity to penicillin-binding proteins (PBPs), particularly PBPs 2 and 3, disrupting the transpeptidation step critical to bacterial cell wall formation, ultimately inducing bacterial cell lysis.
The spectrum of antibacterial activity includes efficacy against various gram-positive and gram-negative organisms, including beta-lactamase producing strains. Notably, cefdinir is active against Haemophilus influenzae, Moraxella catarrhalis, Streptococcus pneumoniae (penicillin-susceptible strains), Streptococcus pyogenes, and Staphylococcus aureus. This broad-spectrum activity renders it effective where first-generation cephalosporins may fail due to resistance.
Pharmacokinetically, cefdinir is primarily eliminated via the renal route, with minimal metabolism. The drug's absorption, distribution, metabolism, and excretion (ADME) properties support its systemic antibacterial efficacy.
Safety considerations include typical cephalosporin class adverse effects, such as hypersensitivity reactions, gastrointestinal disturbances, and potential for Clostridioides difficile-associated diarrhea. Renal function assessment is advised prior to dose adjustments due to renal excretion pathways.
Cefdinir was first approved by the U.S. Food and Drug Administration (FDA) in 1997 and has been marketed under brand names including Omnicef. For API procurement, sourcing from manufacturers adhering to current Good Manufacturing Practices (cGMP) with demonstrated compliance to pharmacopeial standards is critical. Additionally, confirmatory analytical characterization to ensure identity, purity, and potency is essential to maintain product quality and regulatory compliance.
Identification & chemistry
| Generic name | Cefdinir |
|---|---|
| Molecule type | Small molecule |
| CAS | 91832-40-5 |
| UNII | CI0FAO63WC |
| DrugBank ID | DB00535 |
Pharmacology
| Summary | Cefdinir is a third-generation cephalosporin antibiotic that exerts bactericidal activity by binding to penicillin-binding proteins (PBPs) 2 and 3, inhibiting bacterial cell wall synthesis through disruption of peptidoglycan transpeptidation. Its six-member dihydrothiazine ring structure confers resistance to beta-lactamase enzymes, enhancing activity against beta-lactamase producing gram-positive and gram-negative bacteria. Additionally, cefdinir has been observed to inhibit extracellular myeloperoxidase release, though the clinical relevance of this effect remains unclear. |
|---|---|
| Mechanism of action | Five-member thiazolidine rings that make up penicillins are replaced in cephalosporins by a six-member dihydrothiazine ring, conferring greater bactericidal activity. This This 6-member ring enables cefdinir and other cephalosporins to resist inactivation by certain bacterial enzymes. With a mechanism similar to other beta-lactam antibiotics, the bactericidal activity of cefdinir is caused by the inhibition of cell wall synthesis via binding to penicillin-binding proteins (PBPs). Cefdinir, like other cephalosporins, penetrates the bacterial cell wall, combats inactivation by beta-lactamase enzymes, and inactivates penicillin-binding proteins. This interferes with the final step of transpeptidation in cell walls, eventually leading to cell lysis, which eventually leads to the death of bacteria that are susceptible to this drug. Cefdinir has shown affinity to penicillin protein binding proteins 2 and 3. It has also been shown to inhibit transpeptidase enzymes of various bacteria, which may play a role in its bactericidal action. One in vitro study suggests that cefdinir inhibits myeloperoxidase release extracellularly. The impact of this potential drug target in relation to its mechanism of action is unknown. |
| Pharmacodynamics | Cefdinir is a bactericidal agent that treats bacterial infections by interfering with cell wall synthesis. Cefdinir exerts broad-spectrum activity against a variety of gram-positive and gram-negative bacterial infections. It is effective against several beta-lactamase enzyme producing bacteria. As a result, many organisms that are resistant to other cephalosporins may be susceptible to cefdinir. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Penicillin-binding protein 2 | Neisseria gonorrhoeae | inhibitor |
| PBP3 | Haemophilus influenzae | inhibitor |
| Myeloperoxidase | Humans | inhibitor |
ADME / PK
| Absorption | Maximal plasma cefdinir concentration can be attained between 2-4 hours after an ingested dose. The bioavailability of cefdinir depends on the formulation used. The estimated bioavailability of cefdinir in the capsule form is approximately 16%-21%, depending on the dose. Absolute bioavailability after the administration of a suspension of cefdinir is 25%.. The Cmax of cefdinir is 1.60 μg/mL after a 300 mg dose with an AUC of 7.05. Cmax is 2.87 μg/mL after a 600 mg dose with an AUC of 11. A meal high in fat can reduce the absorption of cefdinir by up to 15%, however, this is not a cause for clinically significant changes, therefore cefdinir may be taken with or without food. When given with aluminum or magnesium-containing antacids or iron, cefdinir absorption may decrease. It is recommended to allow 2 hours between cefdinir administration and the administration of these agents. |
|---|---|
| Half-life | The average plasma elimination half-life is about 1.7 hours in adults. In children and healthy infants, plasma elimination half-life ranges from 1.2–1.5 hours. |
| Protein binding | The plasma protein binding of cefdinir ranges from 60% to approximately 70%. |
| Metabolism | This drug is not significantly metabolized and its pharmacological actions are mainly attributed to the parent drug. |
| Route of elimination | This drug is mainly excreted by the kidneys. Dose adjustments may be required for patients with renal impairment or patients on dialysis. Approximately 18.4% of a 300 mg dose of cefdinir was found unchanged in the urine after a 300 mg dose was administered during a pharmacokinetic study of 21 individuals. A large proportion of the administered dose is excreted in the feces, although the majority is found in the urine. |
| Volume of distribution | The average volume of distribution of cefdinir in adults is about 0.35 L/kg and 0.67 L/kg in children. Another resource estimates the volume of distribution in adults at 1.56–2.09 L/kg. Cefdinir is found to be distributed in various tissues at clinically effective concentrations. It may be found in the epithelial lining fluid, bronchial mucosa, tonsils, sinuses, skin blister fluid, as well as the middle ear fluid. Third-generation cephalosporins such as cefdinir cross the blood-brain barrier and are found in high concentrations in the cerebrospinal fluid, unlike their first and second generation counterparts. The wide tissue distribution of cefdinir allows it to treat a variety of infections throughout the body. |
| Clearance | The renal clearance in healthy adults in a pharmacokinetic study was 2.0 (± 1.0) mL/min/kg and the clearance in patients with renal failure was lower, decreasing in proportion to the degree of renal impairment. Dose adjustment is required in patients with renal impairment. |
Formulation & handling
- Cefdinir is a small molecule cephalosporin antibiotic intended for oral administration in multiple solid and suspension dosage forms.
- This API exhibits low water solubility and moderate lipophilicity (LogP -0.89), which may influence formulation strategies for enhancing bioavailability.
- Avoid co-administration with multivalent cation-containing products (aluminum, magnesium, iron) to prevent chelation and reduced absorption; food intake does not affect its oral bioavailability.
Regulatory status
| Lifecycle | The API's primary patent expired in the United States on December 4, 2011, allowing for generic competition. The product is currently marketed in the US, representing a mature market with established availability of alternative formulations. |
|---|
| Markets | US |
|---|
Supply Chain
| Supply chain summary | Cefdinir is supplied by multiple manufacturers and packagers, including well-established generics companies such as Aurobindo Pharma, Lupin, Sandoz, and Teva, indicating a competitive manufacturing landscape. Branded cefdinir products are primarily present in the US market. The listed US patent expired in 2011, suggesting that generic competition is well-established. |
|---|
Safety
| Toxicity | LD50 information Oral LD50 of cefdinir in the rat is >2000 mg/kg. There are limited data regarding cefdinir overdose in the literature. In studies of rodents, one 5600-mg/kg dose administered orally did not lead to adverse effects. Signs of toxicity and overdose caused by other beta-lactam antibiotics included nausea, vomiting, diarrhea, abdominal pain, and seizures. |
|---|
- Oral LD50 in rats exceeds 2000 mg/kg, indicating low acute toxicity at typical exposure levels
- High-dose oral administration (up to 5600 mg/kg) in rodents showed no adverse effects
- Overdose of related beta-lactam antibiotics may cause gastrointestinal disturbances and central nervous system effects such as seizures
Cefdinir 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.
Cefdinir API manufacturers & distributors
Compare qualified Cefdinir API suppliers worldwide. We currently have 12 companies offering Cefdinir 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 |
|---|---|---|---|---|---|
| Amicogen | Producer | China | China | CoA, EDMF/ASMF, GMP, JDMF | 3 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 |
| Covalent Labs. | Producer | India | India | CoA, GMP, USDMF, WC | 5 products |
| Hanmi Fine Chemical | Producer | South Korea | South Korea | CoA, JDMF | 18 products |
| Lupin | Producer | India | India | CoA, USDMF | 155 products |
| Parabolic Drugs | Producer | India | India | CoA, FDA, GMP, WC | 11 products |
| Qilu Antibiotics | Producer | China | China | CoA, WC | 33 products |
| Sandoz | Producer | Austria | Unknown | CoA, USDMF | 58 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Tresinde Biotech | Producer | India | India | CoA, GMP | 50 products |
| Yungjin Pharmaceutical | Producer | South Korea | South Korea | CoA, JDMF | 10 products |
| Zhejiang Apeloa Tospo-Jia... | Producer | China | China | CoA, JDMF | 15 products |
When sending a request, specify which Cefdinir 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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