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Orbifloxacin | CAS No: 113617-63-3 | GMP-certified suppliers

A medication that treats bacterial infections in dogs with broad-spectrum antibacterial activity and requires careful quality control due to potential QTc prolongation and enzyme inhibition effects.

Therapeutic categories

Anti-Bacterial AgentsCytochrome P-450 CYP1A2 InhibitorsCytochrome P-450 CYP1A2 Inhibitors (strength unknown)Cytochrome P-450 Enzyme InhibitorsFluoroquinolonesHeterocyclic Compounds, Fused-Ring
Generic name
Orbifloxacin
Molecule type
small molecule
CAS number
113617-63-3
DrugBank ID
DB11443
Approval status
Vet_approved drug

Product Snapshot

  • Orbifloxacin is an oral small molecule antibiotic formulation
  • It is primarily indicated for veterinary bacterial infections
  • The product holds approval for veterinary use only and is not approved for human markets

Clinical Overview

Orbifloxacin is a fluoroquinolone antibiotic primarily indicated for use in veterinary medicine, specifically approved for treatment of bacterial infections in dogs. It belongs to the quinoline carboxylic acid chemical class, characterized by a quinoline ring substituted with a carboxyl group. Orbifloxacin exhibits broad-spectrum antibacterial activity typical of fluoroquinolones, targeting a range of Gram-negative and Gram-positive pathogens associated with canine infections.

The mechanism of action of orbifloxacin involves inhibition of bacterial DNA gyrase and topoisomerase IV enzymes, essential for DNA replication, transcription, and repair. This inhibition leads to disruption of bacterial DNA processes, resulting in bactericidal effects. Orbifloxacin may also interact with human cytochrome P450 enzymes, notably acting as an inhibitor of CYP1A2, which has implications for potential drug-drug interactions.

Pharmacokinetic data highlight that orbifloxacin has favorable absorption following administration, with distribution properties suitable for targeting relevant tissues in veterinary patients. The drug undergoes metabolism with partial involvement of the cytochrome P450 system and is eliminated primarily via renal excretion. Specific parameters such as bioavailability, half-life, and volume of distribution are documented in veterinary pharmacology references but vary based on formulation and species.

Safety and toxicity considerations include a potential for adverse effects common to fluoroquinolones, such as cartilage toxicity in growing animals and risks associated with QTc interval prolongation, underlying the need for cautious use in animals with predisposing conditions. Orbifloxacin's classification as a potential QTc-prolonging agent warrants attention in clinical contexts. Resistance development is a known concern for fluoroquinolone antibiotics.

Orbifloxacin is marketed under veterinary pharmaceutical formulations by Schering-Plough Animal Health. In procurement and quality assurance of orbifloxacin active pharmaceutical ingredient (API), attention should be given to its chemical purity, polymorphic form, residual solvents, and compliance with relevant pharmacopoeial standards. Reliable sourcing from manufacturers with validated quality control processes is critical to ensure consistent performance and safety in veterinary applications.

Identification & chemistry

Generic name Orbifloxacin
Molecule type Small molecule
CAS 113617-63-3
UNII 660932TPY6
DrugBank ID DB11443

Formulation & handling

  • Orbifloxacin is a small molecule quinoline carboxylic acid primarily formulated for oral administration in veterinary applications.
  • Low water solubility suggests formulation strategies to enhance bioavailability should be considered.
  • Stability under standard storage conditions is expected, but protection from extreme moisture and heat is advisable.

Regulatory status

Orbifloxacin 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.