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Doxycycline | CAS No: 564-25-0 | GMP-certified suppliers
A medication that treats a broad range of bacterial infections, including Lyme disease, rickettsial illnesses, respiratory and sexually transmitted infections, and also supports malaria prophylaxis for short‑term travelers.
Therapeutic categories
Primary indications
- Doxycycline is indicated for the treatment of various infections by gram-positive and gram-negative bacteria, aerobes and anaerobes, as well other types of bacteria, including:
- Early Lyme disease (as evidenced by erythema migraines) due to _Borrelia burgdorferi_ in adults and pediatric patients 8 years of age and older weighing 45 kg and above
- Rickettsial infections,such as Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox, and tick fevers
- Sexually transmitted infections
Product Snapshot
- Doxycycline is a small-molecule tetracycline antibiotic available in oral, intravenous, and topical formulations
- It is used across a broad range of bacterial and atypical pathogen indications, including respiratory, vector‑borne, STI, and other gram-positive/gram-negative infections
- It is approved in the US and Canada, with established regulatory status for multiple human and veterinary applications
Clinical Overview
Doxycycline is primarily bacteriostatic. It inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit and blocking aminoacyl‑tRNA access to the A site, thereby interrupting the elongation phase of translation. Its high lipophilicity facilitates intracellular penetration, supporting activity against intracellular bacteria and certain parasites. Anti‑inflammatory effects occur through inhibition of calcium‑dependent microtubule assembly, reduced lymphocyte proliferation, impaired leukocyte migration, and suppression of nitric oxide synthase.
Absorption after oral administration is high, and systemic exposure is influenced by divalent cations. Distribution is extensive due to lipophilicity. Elimination occurs through both biliary and renal pathways. Doxycycline is associated with photosensitivity, gastrointestinal irritation, potential esophageal injury, and tooth discoloration in pediatric populations. Cross‑resistance within the tetracycline class is common.
Widely used brands include oral and injectable formulations for human and veterinary applications.
For API procurement, suppliers should provide evidence of compliance with pharmacopoeial monographs, validated impurity controls specific to tetracycline‑related degradation pathways, and stability data supporting protection from humidity, heat, and light.
Identification & chemistry
| Generic name | Doxycycline |
|---|---|
| Molecule type | Small molecule |
| CAS | 564-25-0 |
| UNII | 334895S862 |
| DrugBank ID | DB00254 |
Pharmacology
| Summary | Doxycycline is a tetracycline antibiotic that binds allosterically to the bacterial 30S ribosomal subunit, blocking aminoacyl‑tRNA access to the A site and inhibiting protein elongation. This results in bacteriostatic activity across a broad range of gram‑positive, gram‑negative, and intracellular organisms, with additional antiparasitic and anti‑inflammatory actions linked to effects on microtubule assembly and nitric oxide synthase. Its high lipophilicity enables effective intracellular penetration, supporting activity against both extracellular and intracellular pathogens. |
|---|---|
| Mechanism of action | Protein synthesis is essential for survival and functioning of cells, including bacteria.Doxycycline inhibits bacterial protein synthesis by allosterically binding to the 30S prokaryotic ribosomal subunit.The drug blocks the association charged aminoacyl-tRNA (aa-tRNA) with the ribosomal A site, which is the acceptor site on the mRNA-ribosome complex. Doxycycline ultimately impedes the elongation phase of protein synthesis and halts the production of essential proteins for bacterial survival and functioning. Doxycycline mediates anti-inflammatory actions by preventing calcium-dependent microtubular assembly and lymphocytic proliferation, thereby inhibiting leukocyte movement during inflammation.It also inhibits nitric oxide synthase, which is an enzyme that produces nitric oxide, an inflammatory signaling molecule. |
| Pharmacodynamics | Doxycycline and other tetracyclines are mainly bacteriostatic and are thought to exert antimicrobial effects by the inhibition of protein synthesis. They suppress the growth of bacteria or keep them in the stationary phase of growth.Tetracyclines have antimicrobial spectrum of activity against a variety of gram-positive and gram-negative microorganisms.Cross-resistance of these microorganisms to tetracyclines is a common occurrence. As it is a highly lipophilic drug, doxycycline crosses multiple membranes of target molecules.Doxycycline shows favorable intra-cellular penetration, with bacteriostatic activity against a wide range of bacteria.Doxycycline also exhibits antiparasitic properties and anti-inflammatory actions.Its anti-inflammatory effects were investigated in various inflammatory skin conditions, such as bullous dermatoses and rosacea. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 30S ribosomal protein | inhibitor |
ADME / PK
| Absorption | Doxycycline is virtually completely absorbed after oral administration with a bioavailability of ranging from 73-95%.Following an oral dose of 500 mg, the C<sub>max</sub> of 15.3 mg/L was reached in four hours. Following a 200 mg dose, normal adult volunteers averaged peak serum levels of 2.6 mcg/mL of doxycycline at 2 hours, decreasing to 1.45 mcg/mL at 24 hours.While a high-fat meal lowers C<sub>max</sub> and the rate of absorption, the effect is not clinically significant. |
|---|---|
| Half-life | There is limited information available. |
| Protein binding | While there is limited information available, tetracyclines bound to plasma proteins in varying degree. |
| Metabolism | There is limited information available. |
| Route of elimination | Tetracyclines, including doxycycline, are concentrated in bile by the liver and excreted in the urine and feces at high concentrations and in a biologically active form.Excretion of doxycycline by the kidney is about 40%/72 hours in individuals with a creatinine clearance of about 75 mL/min. This percentage may fall as low as 1-5%/72 hours in individuals with a creatinine clearance below 10 mL/min. |
| Volume of distribution | There is limited information available. |
| Clearance | Population pharmacokinetic analysis of sparse concentration-time data of doxycycline following standard of care intravenous and oral dosing in 44 pediatric patients two to 18 years of age showed allometrically -scaled clearance (CL) ranging from 3.27 to 3.58 L/h/70 kg. |
Formulation & handling
- Oral formulations may require strategies to mitigate reduced absorption in the presence of calcium and other multivalent ions.
- Low water solubility and hydrophilicity (logP −3.3) favor use of salts or pH‑adjusted solutions for reconstitution and IV formulations.
- Solid oral forms often use enteric or delayed‑release coatings to improve gastric tolerability and protect the API from acid‑mediated degradation.
Regulatory status
| Lifecycle | Most U.S. patents for the API have expired, with remaining protection ending between 2027 and 2028, placing it in a late‑lifecycle phase. In the US and Canada, the market is likely characterized by established generic availability and mature competition. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Doxycycline’s supply landscape is dominated by numerous generic manufacturers, with the original product lineage tied to long‑established originator firms but now far overshadowed by a broad base of U.S. producers and packagers. Branded formulations remain available in the U.S. and Canada, but global distribution is largely generic. Most key patents covering newer formulations expire between 2022 and 2028, indicating that core API competition is already mature and any remaining protection relates mainly to specific dosage forms rather than the molecule itself. |
|---|
Safety
| Toxicity | Oral LD<sub>50</sub> is 2000 mg/kg in rats, 1870 mg/kg in mice, and 500 mg/kg in dog. In case of overdosage, doxycycline should be discontinued and symptomatic and supportive treatment should be initiated. Dialysis does not alter serum half-life and thus would not be of benefit in treating cases of overdosage. |
|---|
- Acute oral toxicity varies by species, with LD50 values of approximately 2000 mg/kg (rat), 1870 mg/kg (mouse), and 500 mg/kg (dog), indicating higher sensitivity in canine models
- Overexposure may produce systemic toxicity
- Hemodialysis does not enhance clearance due to limited impact on serum half‑life
Doxycycline is a type of Tetracyclines
Tetracyclines are a widely used subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that play a crucial role in the treatment of various bacterial infections. They belong to the class of antibiotics and are characterized by their tetracyclic chemical structure. Tetracyclines exhibit broad-spectrum activity against both Gram-positive and Gram-negative bacteria, making them highly effective in combating a wide range of infections.
These APIs work by inhibiting protein synthesis in bacteria, thereby preventing their growth and reproduction. Tetracyclines bind to the bacterial ribosome, specifically the 30S subunit, and disrupt the addition of amino acids to the growing peptide chain, ultimately leading to bacterial cell death.
Due to their broad antimicrobial spectrum and efficacy, tetracyclines are utilized in the treatment of various infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, sexually transmitted diseases, and certain types of acne. Moreover, they have been used in the management of certain protozoal infections.
It is important to note that tetracyclines are subject to certain limitations and considerations. Their usage is contraindicated in pregnant women, children, and individuals with hepatic or renal impairments. Tetracyclines also exhibit photosensitivity, which may necessitate sun protection measures during treatment.
In summary, tetracyclines are a valuable subcategory of pharmaceutical APIs that offer broad-spectrum antimicrobial activity. Their effectiveness against a wide range of bacterial infections has made them indispensable in modern medicine, though their usage requires careful consideration of individual patient factors and potential side effects.
Doxycycline (Tetracyclines), 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.
Doxycycline API manufacturers & distributors
Compare qualified Doxycycline API suppliers worldwide. We currently have 17 companies offering Doxycycline API, with manufacturing taking place in 8 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 |
|---|---|---|---|---|---|
| Apollo Healthcare Resourc... | Distributor | Singapore | Singapore | BSE/TSE, CEP, CoA, EDMF/ASMF, FDA, GMP, ISO9001, JDMF, KDMF, MSDS, USDMF, WC | 200 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| AXXO GmbH | Distributor | Germany | World | CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Changzhou Comwin Fine Che... | Producer | China | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 235 products |
| Changzhou Pharma | Producer | China | China | CoA, USDMF | 9 products |
| Duchefa Farma B.V. | Distributor | Netherlands | China | BSE/TSE, CoA, GMP, ISO9001, MSDS, WC | 170 products |
| Hovione Farmaciencia | Producer | Portugal | Portugal | CoA, JDMF, USDMF | 16 products |
| Indukern Chemie AG | Distributor | Switzerland | Unknown | CoA | 13 products |
| Kaifeng Pharma | Producer | China | China | CEP, CoA | 1 products |
| LGM Pharma | Distributor | United States | World | BSE/TSE, CEP, CoA, GMP, MSDS, USDMF | 441 products |
| Raks Pharma | Producer | India | India | CEP, CoA, FDA, USDMF | 58 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, USDMF | 144 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 757 products |
| Sun Pharma | Producer | India | India | CoA, GMP, WC | 219 products |
| Veeprho Group | Producer | Czech Republic | Czech Republic | CoA | 133 products |
| Yangzhou Liberty | Producer | China | China | CEP, CoA, FDA, GMP | 2 products |
When sending a request, specify which Doxycycline 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 Doxycycline 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.
Frequently asked questions about Doxycycline API
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Technical
What is Doxycycline (CAS 564-25-0) used for?
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Regulatory
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