- Raw materials
- Antibacterials
- Tetracyclines
- Tigecycline
Filters
Custom request?
Type
Production region
Qualifications
Country of origin
Tigecycline API Manufacturers & Suppliers
10 verified results
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Commercial-scale Suppliers
Employees: 25+
All certificates
Employees: 10+
All certificates
Employees: 50
All certificates
Employees: 50+
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
All certificates
Total market transparency
Supplier trade data access
Buyer / supplier flow comparison
Tigecycline | CAS No: 220620-09-7 | GMP-certified suppliers
A medication that treats complicated skin, skin structure, and intra-abdominal infections caused by multidrug-resistant and susceptible bacterial strains, including MRSA and anaerobes.
Therapeutic categories
Primary indications
- For the treatment of infections caused by susceptible strains of the designated microorganisms in the following conditions: Complicated skin and skin structure infections caused by <i>Escherichia coli</i>, <i>Enterococcus faecalis</i> (vancomycin-susceptible isolates only), <i>Staphylococcus aureus</i> (methicillin-susceptible and -resistant isolates), <i>Streptococcus agalactiae</i>, <i>Streptococcus anginosus</i> grp
- (includes <i>S
- Anginosus</i>, <i>S
- Intermedius</i>, and <i>S
Product Snapshot
- Tigecycline is an injectable peptide antibiotic provided as a lyophilized powder for intravenous solution
- Its primary therapeutic use is in the treatment of complicated skin and skin structure infections and complicated intra-abdominal infections caused by susceptible bacterial strains
- Tigecycline is approved for use in key regulatory markets including the US, Canada, and the EU
Clinical Overview
Pharmacologically, tigecycline belongs to the tetracycline class of antibiotics, structurally characterized by an octahydrotetracene-2-carboxamide core with multiple hydroxy and other substituents. It is the first clinically available agent in the glycylcycline subclass, structurally derived from minocycline with a glycylamido substitution at the 9-position, which enhances its activity against resistant bacteria. Tigecycline inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, specifically blocking the entry of amino-acyl tRNA into the A site and thereby preventing peptide chain elongation. This mechanism is similar to that of tetracyclines but with improved binding efficiency and resistance profile. Tigecycline is not affected by common tetracycline resistance mechanisms such as efflux pumps and ribosomal protection proteins, nor by other resistance factors including beta-lactamases or macrolide efflux.
Key ADME characteristics include extensive tissue distribution and a bacteriostatic mode of action. Tigecycline demonstrates no cross-resistance with other antibiotic classes and generally exhibits no antagonism when combined with other antibacterial agents. Safety considerations highlight known risks associated with tetracycline derivatives, such as nausea, vomiting, and potential effects on teeth and bone development; use in pregnant women and pediatric populations should be carefully evaluated.
Tigecycline is marketed under the brand name Tygacil by Wyeth and has been FDA-approved since June 2005 with fast-track designation. When sourcing tigecycline active pharmaceutical ingredient (API), ensuring compliance with stringent quality standards, including validated impurity profiles and consistent potency, is essential. Suppliers must provide full documentation on manufacturing processes, impurity control, and stability to support regulatory submissions and maintain clinical efficacy.
Identification & chemistry
| Generic name | Tigecycline |
|---|---|
| Molecule type | Small molecule |
| CAS | 220620-09-7 |
| UNII | 70JE2N95KR |
| DrugBank ID | DB00560 |
Pharmacology
| Summary | Tigecycline is a glycylcycline antibiotic that inhibits bacterial protein synthesis by binding to the 30S ribosomal subunit, blocking amino-acyl tRNA entry and preventing peptide elongation. It retains activity against a broad spectrum of pathogens, including strains resistant to tetracyclines, due to its unique structural modifications that overcome common resistance mechanisms such as efflux pumps and ribosomal protection. Tigecycline exhibits primarily bacteriostatic effects without cross-resistance to other major antibiotic classes. |
|---|---|
| Mechanism of action | Tigecycline, a glycylcycline, inhibits protein translation in bacteria by binding to the 30S ribosomal subunit and blocking entry of amino-acyl tRNA molecules into the A site of the ribosome. This prevents incorporation of amino acid residues into elongating peptide chains. Tigecycline carries a glycylamido moiety attached to the 9-position of minocycline. The substitution pattern is not present in any naturally occurring or semisynthetic tetracycline and imparts certain microbiologic properties to tigecycline. Tigecycline is not affected by the two major tetracycline resistance mechanisms, ribosomal protection and efflux. Accordingly, tigecycline has demonstrated in vitro and in vivo activity against a broad spectrum of bacterial pathogens. There has been no cross resistance observed between tigecycline and other antibiotics. Tigecycline is not affected by resistance mechanisms such as beta-lactamases (including extended spectrum beta-lactamases), target site modifications, macrolide efflux pumps or enzyme target changes (e.g. gyrase/topoisomerase). In vitro studies have not demonstrated antagonism between tigecycline and other commonly used antibacterial drugs. In general, tigecycline is considered bacteriostatic. |
| Pharmacodynamics | Tigecycline is the first clinically-available drug in a new class of antibiotics called the glycylcyclines. Glycylcyclines are a new class of antibiotics derived from tetracycline. These tetracycline analogues are specifically designed to overcome two common mechanisms of tetracycline resistance, namely resistance mediated by acquired efflux pumps and/or ribosomal protection. Glycylcycline antibiotics have a similar mechanism of action as tetracycline antibiotics. Both classes of antibiotics bind to the 30S ribosomal subunit to prevent the amino-acyl tRNA from binding to the A site of the ribosome. However, the glycylcyclines appear to bind more effectively than the tetracyclines. |
Targets
| Target | Organism | Actions |
|---|---|---|
| 16S ribosomal RNA | Enteric bacteria and other eubacteria | binder |
| 30S ribosomal protein S9 | Escherichia coli (strain K12) | binder |
| 30S ribosomal protein S12 | Escherichia coli (strain K12) | binder |
ADME / PK
| Half-life | 27-43 hours |
|---|---|
| Protein binding | 71% to 89% |
| Metabolism | Tigecycline is not extensively metabolized. In vitro studies with tigecycline using human liver microsomes, liver slices, and hepatocytes led to the formation of only trace amounts of metabolites. A glucuronide, an N-acetyl metabolite, and a tigecycline epimer (each at no more than 10% of the administered dose) are the primary metabolites. |
Formulation & handling
- Tigecycline is a small molecule antibiotic formulated predominantly for intravenous administration as a lyophilized powder for solution or solution form.
- The compound exhibits low lipophilicity (LogP -3.9) and moderate water solubility, requiring appropriate reconstitution and handling for parenteral use.
- No notable peptide or biologic characteristics are present, and formulation should consider stability post-reconstitution and sensitivity to light or temperature based on standard tetracycline derivatives.
Regulatory status
| Lifecycle | The API is mature in the US and Canadian markets with initial patents expired, though newer patents provide protection in the US until 2030. In the EU market, patent status should be further assessed to determine market exclusivity. |
|---|
| Markets | US, Canada, EU |
|---|
Supply Chain
| Supply chain summary | Tigecycline is primarily produced by a single originator company, with multiple packaging partners supporting its distribution. The branded product maintains a presence in key markets including the US, Canada, and the EU. Existing patents extend into the late 2020s, indicating ongoing exclusivity and limited generic competition at present. |
|---|
Safety
| Toxicity | Since glycylcyclines are similar to tetracyclines, they share many of the same side effects and contraindications as tetracyclines. These side effects may include nausea/vomiting, headache, photosensitivity, discoloration of growing teeth, and fetal damage. |
|---|
- May cause photosensitivity
- Avoid exposure to direct light during handling to reduce risk of dermal reactions
- Potential for fetal toxicity
Tigecycline 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.
Tigecycline (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.
Tigecycline API manufacturers & distributors
Compare qualified Tigecycline API suppliers worldwide. We currently have 10 companies offering Tigecycline 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 |
|---|---|---|---|---|---|
| Apino Pharma Co., Ltd. | Producer | China | China | BSE/TSE, CoA, GMP, MSDS, USDMF | 229 products |
| AXXO GmbH | Distributor | Germany | World | CoA, GMP, GDP, MSDS, USDMF | 243 products |
| Jiwan Pharmaceutical Tech... | Producer | China | China | CoA, GMP, MSDS, USDMF | 8 products |
| Maithri Drugs | Producer | India | India | CoA, USDMF, WC | 12 products |
| Rochem International, Inc... | Distributor | United States | United States | BSE/TSE, CoA, EDMF/ASMF, GMP, ISO9001, MSDS, USDMF | 144 products |
| Sandoz | Producer | Austria | India | CoA, GMP, USDMF, WC | 58 products |
| Senova Technology Co., Lt... | Producer | China | China | CoA, GMP, ISO9001, USDMF | 157 products |
| Suntril Pharmaceuticals P... | Producer | India | India | BSE/TSE, CoA, ISO9001, MSDS, USDMF, WHO-GMP | 2 products |
| Wuhan ZhongYou | Producer | China | China | CoA, USDMF | 4 products |
| Zhejiang Hisun Pharma | Producer | China | China | CoA, USDMF | 69 products |
When sending a request, specify which Tigecycline 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 Tigecycline 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.
