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Tetracycline | CAS No: 60-54-8 | GMP-certified suppliers
A medication that treats a broad range of bacterial infections, including rickettsial, chlamydial, Lyme, respiratory conditions, and acne, and offers an option for penicillin‑allergic patients.
Therapeutic categories
Primary indications
- Used to treat bacterial infections such as Rocky Mountain spotted fever, typhus fever, tick fevers, Q fever, rickettsialpox and Brill-Zinsser disease
- May be used to treat infections caused by Chlamydiae spp
- , B
- Burgdorferi (Lyme disease), and upper respiratory infections caused by typical (S
Product Snapshot
- Tetracycline is a small-molecule antibiotic available in oral, topical, ophthalmic, dental, and vaginal formulations
- It is used across a broad range of bacterial infections including rickettsial diseases, atypical and typical respiratory pathogens, Chlamydiae, Lyme disease, and acne
- It is approved in the US and Canada, with some formulations carrying veterinary or withdrawn status
Clinical Overview
Tetracycline exerts a bacteriostatic effect by inhibiting bacterial protein synthesis. It passively diffuses through porin channels and binds reversibly to the 30S ribosomal subunit, preventing aminoacyl‑tRNA attachment to the A site of the mRNA‑ribosome complex. It also exhibits ancillary binding to the 50S subunit. Disruption of the bacterial cytoplasmic membrane has been reported, leading to leakage of intracellular components. These combined actions reduce bacterial growth but do not directly induce bactericidal activity.
Tetracycline is a short‑acting agent. Renal excretion contributes substantially to its elimination, and its classification as a substrate and inhibitor of CYP3A pathways and several organic anion transporters indicates potential for clinically relevant drug–drug interactions. Use in pediatric populations requires attention to regulatory constraints; the FDA has withdrawn approval for liquid oral pediatric formulations exceeding 25 mg per mL, although other formulations remain available.
Safety considerations include photosensitivity reactions, gastrointestinal intolerance, and the potential for effects on teeth and bone development in children. As with other tetracyclines, caution is warranted in patients with impaired renal function due to accumulation risk.
In API procurement, sourcing should prioritize manufacturers with robust control of polymorphic form, impurity profile, and stability data, ensuring compliance with pharmacopeial specifications and regulatory expectations for antibacterial substances.
Identification & chemistry
| Generic name | Tetracycline |
|---|---|
| Molecule type | Small molecule |
| CAS | 60-54-8 |
| UNII | F8VB5M810T |
| DrugBank ID | DB00759 |
Pharmacology
| Summary | Tetracycline is a short‑acting antimicrobial agent that inhibits bacterial protein synthesis by reversibly binding to the 30S ribosomal subunit, blocking aminoacyl‑tRNA attachment and stalling translation. It interacts with several ribosomal proteins and 16S rRNA, with minor binding to the 50S subunit, and can also disrupt bacterial membrane integrity. These combined actions suppress bacterial growth across a broad range of susceptible organisms. |
|---|---|
| Mechanism of action | Tetracycline passively diffuses through porin channels in the bacterial membrane and reversibly binds to the 30S ribosomal subunit, preventing binding of tRNA to the mRNA-ribosome complex, and thus interfering with protein synthesis. |
| Pharmacodynamics | Tetracycline is a short-acting antibiotic that inhibits bacterial growth by inhibiting translation. It binds to the 30S ribosomal subunit and prevents the amino-acyl tRNA from binding to the A site of the ribosome. It also binds to some extent to the 50S ribosomal subunit. This binding is reversible in nature. Additionally tetracycline may alter the cytoplasmic membrane of bacteria causing leakage of intracellular contents, such as nucleotides, from the cell. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 30S ribosomal protein S7 | Escherichia coli (strain K12) | inhibitor |
| 30S ribosomal protein S14 | Escherichia coli (strain K12) | inhibitor |
| 30S ribosomal protein S3 | Escherichia coli (strain K12) | inhibitor |
ADME / PK
| Absorption | Bioavailability is less than 40% when administered via intramuscular injection, 100% intravenously, and 60-80% orally (fasting adults). Food and/or milk reduce GI absorption of oral preparations of tetracycline by 50% or more. |
|---|---|
| Half-life | 6-12 hours |
| Protein binding | 20 - 67% protein bound |
| Metabolism | Not metabolized |
| Route of elimination | They are concentrated by the liver in the bile and excreted in the urine and feces at high concentrations in a biologically active form. |
Formulation & handling
- Oral formulations must account for reduced absorption in the presence of divalent cations such as those in dairy products.
- The highly water‑soluble, hydrophilic small molecule is suitable for oral and topical dosage forms but is sensitive to pH‑dependent degradation.
- Ophthalmic and topical preparations require protection from light, as tetracyclines are photosensitive and can discolor on exposure.
Regulatory status
| Lifecycle | The API’s U.S. patent expired in 2018, indicating that it is now in a mature stage of market availability. With products marketed in the United States and Canada, the ingredient is established in both markets and no longer protected by primary patent exclusivity. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Tetracycline has numerous historical originator and legacy manufacturers, reflecting a mature product with well‑established production across several large pharmaceutical companies and their former divisions. Branded formulations have long been available in the US and Canada, with limited recent activity outside these markets. The listed US patent expired in 2018, consistent with the extensive generic competition already present. |
|---|
Safety
| Toxicity | LD<sub>50</sub>=808mg/kg (orally in mice) |
|---|
- Oral LD50 in mice is approximately 808 mg/kg, indicating moderate acute toxicity
- Avoid ingestion and limit exposure to dust or aerosols
- Photosensitivity and dermal irritation can occur with contact
Certificate of Analysis
A CoA is a document issued by a companies’ QA/QC-department that confirms that a product meets its product specification and is part of the quality control of a product batch. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example: Ph. Eur. | EP – (European Pharmacopoeia) USP – (United States Pharmacopeia)
Tetracycline 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.
Tetracycline (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.
Tetracycline API manufacturers & distributors
Compare qualified Tetracycline API suppliers worldwide. We currently have 7 companies offering Tetracycline API, with manufacturing taking place in 2 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 |
|---|---|---|---|---|---|
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, FDA, GMP, ISO9001, MSDS, USDMF, WC | 250 products |
| Cipan | Producer | Portugal | Portugal | CoA, GMP, USDMF | 7 products |
| Fujian Fukang Pharma | Producer | China | China | CoA, WC | 4 products |
| Shaoxing Hantai Pharma | Distributor | China | China | CoA | 162 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CoA, GMP, ISO9001, MSDS | 762 products |
| Suanfarma | Distributor | Spain | Portugal | CEP, CoA, FDA, GDP, GMP, ISO9001, USDMF | 13 products |
| Xi’an Lijun Pharma | Producer | China | China | CoA, USDMF | 2 products |
When sending a request, specify which Tetracycline 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 Tetracycline 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 Tetracycline API
Sourcing
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Technical
What is Tetracycline (CAS 60-54-8) used for?
Which therapeutic class does Tetracycline fall into?
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How does Tetracycline work?
What should someone know about the safety or toxicity profile of Tetracycline?
What are important formulation and handling considerations for Tetracycline as an API?
Is Tetracycline a small molecule?
Are there special stability concerns for oral Tetracycline?
Regulatory
Where is Tetracycline approved or in use globally?
Pharmaoffer
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