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Roxithromycin API Manufacturers & Suppliers

14 verified results
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Commercial-scale Suppliers

Distributor
Produced in  China
|

Employees: 50+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
CEP
|
USDMF
|
ISO9001
|
CoA

All certificates

GMP
CEP
USDMF
ISO9001
CoA
Distributor
Produced in  World
|

Employees: 50

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
CEP
|
MSDS
|
CoA
|
ISO9001

All certificates

GMP
CEP
MSDS
CoA
ISO9001
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Distributor
Produced in  China
|

Employees: 150

|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
CEP
|
USDMF
|
MSDS
|
CoA

All certificates

GMP
CEP
USDMF
MSDS
CoA
Distributor
Produced in  China
|

Employees: 50+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
CEP
|
MSDS
|
BSE/TSE
|
ISO9001

All certificates

GMP
CEP
MSDS
BSE/TSE
ISO9001
CoA
Distributor
Produced in  China
|

Employees: 200+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
MSDS
|
BSE/TSE
|
CoA

All certificates

GMP
MSDS
BSE/TSE
CoA
Producer
Produced in  China
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
CEP
|
WC
|
CoA

All certificates

GMP
CEP
WC
CoA
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€399,-
All Roxithromycin data. Full access. Full negotiation power
Producer
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
CEP
|
coa
|
KDMF

All certificates

GMP
CEP
coa
KDMF
Producer
Produced in  India
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
FDA
|
CEP
|
coa
|
WC

All certificates

GMP
FDA
CEP
coa
WC
Get full market intelligence report
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€399,-
All Roxithromycin data. Full access. Full negotiation power
Producer
Produced in  Portugal
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: JDMF
|
CoA

All certificates

JDMF
CoA
Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
ISO 9001
|
CoA

All certificates

GMP
ISO 9001
CoA
Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: coa

All certificates

coa
Producer
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
CoA

All certificates

GMP
CoA
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Producer
Produced in  France
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
CoA

All certificates

GMP
CoA
Not active
Distributor
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: coa

All certificates

coa
Not active
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Roxithromycin | CAS No: 80214-83-1 | GMP-certified suppliers

A medication that treats respiratory, urinary, and soft tissue infections with broad antibacterial activity against common Gram-positive and Gram-negative pathogens.

Therapeutic categories

Anti-Bacterial AgentsAnti-Infective AgentsAntibacterials for Systemic UseAntiinfectives for Systemic UseCytochrome P-450 CYP2B6 InhibitorsCytochrome P-450 CYP2B6 Inhibitors (strength unknown)
Generic name
Roxithromycin
Molecule type
small molecule
CAS number
80214-83-1
DrugBank ID
DB00778
Approval status
Approved drug, Investigational drug, Withdrawn drug
ATC code
J01FA06

Primary indications

  • Used to treat respiratory tract, urinary and soft tissue infections

Product Snapshot

  • Roxithromycin is available primarily as oral tablets, powders for suspension, granules, and capsules, encompassing both film-coated and soluble formulations
  • It is indicated for the treatment of respiratory tract, urinary, and soft tissue infections
  • Regulatory status varies by market, including approved, investigational, and withdrawn classifications

Clinical Overview

Roxithromycin (CAS Number 80214-83-1) is a semi-synthetic macrolide antibiotic structurally related to erythromycin, azithromycin, and clarithromycin. It is primarily indicated for the treatment of respiratory tract infections, urinary tract infections, and soft tissue infections. Roxithromycin demonstrates enhanced efficacy against certain Gram-negative bacteria, notably Legionella pneumophila.

Pharmacologically, roxithromycin exerts its antibacterial activity by binding to the 50S subunit of bacterial ribosomes. This interaction inhibits the translocation step in peptide elongation during protein synthesis, resulting in bacteriostatic effects. Its spectrum of activity includes a range of pathogens such as Streptococcus pneumoniae, Neisseria meningitidis, Mycoplasma pneumoniae, Chlamydia trachomatis, Haemophilus species, and others. Roxithromycin is highly concentrated intracellularly within polymorphonuclear leukocytes and macrophages, achieving levels greater than those in extracellular fluids. This accumulation enhances phagocytic and chemotactic functions of immune cells, facilitating bacterial clearance through intracellular bactericidal activity.

From an absorption, distribution, metabolism, and excretion (ADME) perspective, roxithromycin is metabolized partially by cytochrome P450 isoenzymes, including CYP3A4 and CYP2B6, and is both a substrate and inhibitor of these enzymes. This dual role necessitates consideration of potential drug-drug interactions. It also acts as an inhibitor of organic anion-transporting polypeptides OATP1B1 and OATP1B3. Roxithromycin is classified among moderate risk QTc-prolonging agents, underscoring the importance of cardiac monitoring in susceptible patients.

Safety considerations include the potential for QT interval prolongation, hypersensitivity reactions typical for macrolides, and hepatotoxicity in rare cases. Careful patient history and monitoring are advised during therapy.

Roxithromycin is marketed in several regions, including Australia, where it is registered for systemic antibacterial indications. Given its involvement in cytochrome P450 pathways, stringent quality control during API manufacturing is crucial to ensure batch-to-batch consistency and minimize impurities that could impact metabolic profiles or safety. Procurement of roxithromycin API should prioritize suppliers compliant with good manufacturing practices (GMP) and regulatory standards relevant to the intended market.

Identification & chemistry

Generic name Roxithromycin
Molecule type Small molecule
CAS 80214-83-1
UNII 21KOF230FA
DrugBank ID DB00778

Pharmacology

SummaryRoxithromycin is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit and blocking peptide translocation. It exhibits bacteriostatic and intracellular bactericidal activity against a broad spectrum of pathogens, including Streptococcus, Neisseria, Mycoplasma, and Chlamydia species. Additionally, roxithromycin accumulates in immune cells, enhancing phagocytic functions to support bacterial clearance.
Mechanism of actionRoxithromycin prevents bacterial growth by interfering with their protein synthesis. It binds to the 50S subunit of bacterial ribosomes and inhibits the translocation of peptides.
PharmacodynamicsRoxithromycin has the following antibacterial spectrum <i>in vitro</i>: <i>Streptococcus agalactiae</i>, <i>Streptococcus pneumoniae</i> (Pneumococcus), <i>Neisseria meningitides</i> (Meningococcus), <i>Listeria monocytogenes</i>, <i>Mycoplasma pneumoniae</i>, <i>Chlamydia trachomatis</i>, <i>Ureaplasma urealyticum</i>, <i>Legionella pneumophila</i>, <i>Helicobacter</i> (Campylobacter), <i>Gardnerella vaginalis</i>, <i>Bordetella pertussis</i>, <i>Moraxella catarrhalis</i> (<i>Branhamella Catarrhalis</i>), and <i>Haemophilus ducreyi</i>. Roxithromycin is highly concentrated in polymorphonuclear leukocytes and macrophages, achieving intracellular concentrations greater than those outside the cell. Roxithromycin enhances the adhesive and chemotactic functions of these cells which in the presence of infection produce phagocytosis and bacterial lysis. Roxithromycin also possesses intracellular bactericidal activity.
Targets
TargetOrganismActions
50S ribosomal protein L10Shigella flexneriinhibitor
P-glycoprotein 1Humans

ADME / PK

AbsorptionVery rapidly absorbed and diffused into most tissues and phagocytes.
Half-life12 hours
Protein binding96%, mainly to alpha1-acid glycoproteins
MetabolismHepatic. Roxithromycin is only partially metabolised, more than half the parent compound being excreted unchanged. Three metabolites have been identified in urine and faeces: the major metabolite is descladinose roxithromycin, with N-mono and N-di-demethyl roxithromycin as minor metabolites. The respective percentage of roxithromycin and these three metabolites is similar in urine and faeces.

Formulation & handling

  • Roxithromycin is a small molecule aminoglycoside antibiotic formulated exclusively for oral administration in various tablet and suspension forms.
  • Due to its low water solubility (0.187 g/L) and moderate lipophilicity (LogP 3), formulation strategies should consider solubility enhancement for consistent bioavailability.
  • As a small molecule, Roxithromycin does not have peptide/biologic sensitivity, but stability considerations should focus on protecting suspension forms from moisture and light exposure.

Regulatory status

Safety

ToxicityRoxithromycin primarily causes gastrointestinal adverse events, such as diarrhoea, nausea, abdominal pain and vomiting. Less common adverse events include headaches, rashes, abnormal liver function values and alteration in senses of smell and taste.
High Level Warnings:
  • May cause gastrointestinal irritation including diarrhoea, nausea, abdominal pain, and vomiting upon exposure
  • Handling requires precautions to avoid dermal or mucosal contact due to potential for rash and sensory alterations
  • Monitor for signs of hepatotoxicity

Roxithromycin is a type of Macrolides


Macrolides are a significant subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that are widely used in the healthcare industry. These compounds belong to a class of antibiotics characterized by a large macrocyclic lactone ring, which is the key structural feature responsible for their therapeutic activity.

Macrolides possess a broad spectrum of activity against various bacteria, making them valuable in the treatment of many bacterial infections. They work by inhibiting the synthesis of bacterial proteins, thereby preventing their growth and replication. This mechanism of action makes macrolides effective against both Gram-positive and some Gram-negative bacteria.

One of the most well-known macrolide antibiotics is erythromycin, which has been used for decades to treat respiratory tract infections, skin infections, and sexually transmitted diseases. Over time, several derivatives and semi-synthetic macrolides have been developed, such as azithromycin and clarithromycin, which offer improved pharmacokinetic properties, increased efficacy, and broader spectrum of activity.

Macrolides are often preferred in clinical practice due to their favorable pharmacokinetics, including high tissue penetration, prolonged half-life, and low toxicity. They are commonly prescribed for patients who are allergic to penicillin or have other contraindications to beta-lactam antibiotics.

In conclusion, macrolides represent a vital subclass of pharmaceutical APIs with potent antibacterial properties. Their broad spectrum of activity, favorable pharmacokinetic profile, and versatility make them indispensable in the treatment of various bacterial infections.


Roxithromycin (Macrolides), classified under 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.



Roxithromycin API manufacturers & distributors

Compare qualified Roxithromycin API suppliers worldwide. We currently have 14 companies offering Roxithromycin API, with manufacturing taking place in 5 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.

SupplierTypeCountryProduct originCertificationsPortfolio
Distributor
China China BSE/TSE, CoA, GMP, MSDS176 products
Distributor
China China BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS250 products
Distributor
Germany World CEP, CoA, GMP, GDP, MSDS243 products
Distributor
Denmark China CEP, CoA, GMP, MSDS, USDMF252 products
Producer
India India CoA, GMP, ISO900116 products
Producer
India India CoA21 products
Producer
Germany China CoA, GMP31 products
Producer
Portugal Portugal CoA, JDMF16 products
Producer
India India CEP, CoA, FDA, GMP, WC8 products
Producer
France France CoA, GMP93 products
Distributor
China China CoA162 products
Distributor
China China CEP, CoA, GMP, ISO9001, USDMF762 products
Producer
China China CEP, CoA, GMP, WC6 products
Producer
China China CEP, CoA, GMP, KDMF3 products

When sending a request, specify which Roxithromycin 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 Roxithromycin 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.