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Piperacillin | CAS No: 66258-76-2 | GMP-certified suppliers
A medication that treats polymicrobial infections with broad-spectrum antibacterial activity, including resistant gram-positive and gram-negative bacteria, supporting systemic anti-infective therapy.
Therapeutic categories
Primary indications
- For the treatment of polymicrobial infections
Product Snapshot
- Piperacillin is available as a powder and solution for injection, formulated for parenteral administration including intravenous and intramuscular routes
- It is primarily used for the treatment of polymicrobial infections
- The product is approved for use in the US and Canadian markets
Clinical Overview
Pharmacodynamically, piperacillin acts as a bactericidal agent by inhibiting bacterial cell wall synthesis. It achieves this by binding to specific penicillin-binding proteins (PBPs) within the bacterial cell wall, thereby disrupting the third and final stage of peptidoglycan cross-linking essential for wall integrity. This leads to bacterial cell lysis mediated by autolytic enzymes such as autolysins. Piperacillin demonstrates stability against hydrolysis by various beta-lactamases, including penicillinases, cephalosporinases, and extended spectrum beta-lactamases, which contributes to its broad utility against resistant strains.
Pharmacokinetically, piperacillin is primarily excreted unchanged via the renal route, consistent with characteristics of beta-lactam antibiotics. It acts as a substrate for renal organic anion transporters OAT1 and OAT3, which influence its renal clearance. Metabolic transformation is minimal, and its distribution reflects typical properties of beta-lactams.
Clinically, piperacillin is often used in combination with beta-lactamase inhibitors to enhance efficacy in resistant infections. Safety considerations include hypersensitivity reactions common to beta-lactam antibiotics, potential nephrotoxicity at high doses or in renal impairment, and monitoring for alterations in coagulation parameters. It does not directly produce neuromuscular blockade but is categorized among agents impacting neuromuscular function indirectly.
In the pharmaceutical supply chain, careful sourcing of high-purity piperacillin API is critical due to its peptide nature and susceptibility to degradation. Stability profiles require controlled storage conditions, and manufacturing processes must ensure low endotoxin levels and conform to pharmacopeial standards. Reliable suppliers providing comprehensive quality documentation and performance consistency support regulatory compliance and formulation development.
Identification & chemistry
| Generic name | Piperacillin |
|---|---|
| Molecule type | Small molecule |
| CAS | 66258-76-2 |
| UNII | 9I628532GX |
| DrugBank ID | DB00319 |
Pharmacology
| Summary | Piperacillin is a beta-lactam antibiotic that exerts bactericidal effects by binding to penicillin-binding proteins (PBPs) involved in bacterial cell wall synthesis, inhibiting the final stage of peptidoglycan cross-linking. This disruption leads to cell lysis mediated by autolytic enzymes. Piperacillin targets multiple PBPs and is active against a broad spectrum of gram-positive and gram-negative aerobic and anaerobic bacteria, including strains producing various beta-lactamases. |
|---|---|
| Mechanism of action | By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, Piperacillin inhibits the third and last stage of bacterial cell wall synthesis. Cell lysis is then mediated by bacterial cell wall autolytic enzymes such as autolysins; it is possible that Piperacillin interferes with an autolysin inhibitor. |
| Pharmacodynamics | Piperacillin is a penicillin beta-lactam antibiotic used in the treatment of bacterial infections caused by susceptible, usually gram-positive, organisms. The name "penicillin" can either refer to several variants of penicillin available, or to the group of antibiotics derived from the penicillins. Piperacillin has <i>in vitro</i> activity against gram-positive and gram-negative aerobic and anaerobic bacteria. The bactericidal activity of Piperacillin results from the inhibition of cell wall synthesis and is mediated through Piperacillin binding to penicillin binding proteins (PBPs). Piperacillin is stable against hydrolysis by a variety of beta-lactamases, including penicillinases, and cephalosporinases and extended spectrum beta-lactamases. |
Targets
| Target | Organism | Actions |
|---|---|---|
| Penicillin-binding protein 3 | Streptococcus pneumoniae | inhibitor |
| Penicillin-binding protein 2B | Streptococcus pneumoniae (strain ATCC BAA-255 / R6) | inhibitor |
| Penicillin-binding protein 2a | Streptococcus pneumoniae (strain ATCC BAA-255 / R6) | inhibitor |
ADME / PK
| Absorption | Not absorbed following oral administration. |
|---|---|
| Half-life | 36-72 minutes |
| Metabolism | Largely not metabolized. |
| Route of elimination | As with other penicillins, PIPRACIL is eliminated primarily by glomerular filtration and tubular secretion; it is excreted rapidly as unchanged drug in high concentrations in the urine. Because PIPRACIL is excreted by the biliary route as well as by the renal route, it can be used safely in appropriate dosage in patients with severely restricted kidney function. |
| Volume of distribution | * 101 mL/kg [intravenous administration of 50 mg/kg (5-minute infusion) in neonates] |
| Clearance | * 32 - 41 mL/min/1.73 m2 * 124 - 160 mL/min/1.73 m2 [older pediatric patients] |
Formulation & handling
- Piperacillin is a small molecule peptide antibiotic formulated primarily for parenteral administration via intravenous or intramuscular injection.
- Due to low water solubility, piperacillin is typically supplied as a powder for reconstitution into injectable solutions.
- Handling requires attention to moisture sensitivity, often necessitating lyophilized powder formulations for improved stability.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient (API) entered the mature market phase in the United States following patent expirations in April 2023 and earlier in 2019, with products also marketed in Canada. This timeline suggests increasing availability of generic alternatives in these regions. |
|---|
| Markets | Canada, US |
|---|
Supply Chain
| Supply chain summary | Piperacillin is manufactured by originator companies including Istituto Biochimico Italiano Giovanni Lorenzini and Wyeth Pharmaceuticals, with packaging performed by APP Pharmaceuticals and Ibi Istituto Biochimico Italiano Giovanni Lorenzini SPA. The product is primarily marketed in North America, specifically the US and Canada, with multiple branded formulations available. The presence of active patents in the US through 2023 indicates existing or potential protection, although some earlier patents have expired, suggesting the possibility of current or upcoming generic competition. |
|---|
Piperacillin is a type of Penicillins
Penicillins belong to the subcategory of pharmaceutical active pharmaceutical ingredients (APIs) and play a crucial role in the treatment of various bacterial infections. They are a class of antibiotics derived from the fungus Penicillium, and are widely used in the pharmaceutical industry.
Penicillins exert their antibacterial effect by inhibiting the formation of bacterial cell walls. They target a specific enzyme, called transpeptidase, which is responsible for cross-linking the peptidoglycan chains in the bacterial cell wall. By blocking this process, penicillins weaken the cell wall, leading to its rupture and subsequent bacterial death.
These APIs are classified into several subclasses, such as penicillin G, penicillin V, and extended-spectrum penicillins. Each subclass has unique characteristics and mechanisms of action. Penicillin G, for example, is effective against a broad range of Gram-positive bacteria, while penicillin V is primarily used for oral administration.
The pharmaceutical industry produces penicillins through a fermentation process using Penicillium strains. The obtained penicillin products are then isolated, purified, and formulated into different dosage forms, including tablets, capsules, and injectables.
Penicillins have been instrumental in the treatment of various infections, including respiratory, skin, urinary tract, and sexually transmitted infections. However, it's essential to note that some bacteria have developed resistance to penicillins through different mechanisms, such as the production of beta-lactamases. As a result, pharmaceutical companies have developed combination therapies and modified penicillins to combat antibiotic resistance effectively.
In summary, penicillins are a vital subcategory of pharmaceutical APIs that provide effective treatment options for bacterial infections. Their diverse subclasses, mechanisms of action, and formulations contribute to their widespread use in the medical field.
Piperacillin (Penicillins), 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.
Piperacillin API manufacturers & distributors
Compare qualified Piperacillin API suppliers worldwide. We currently have 14 companies offering Piperacillin API, with manufacturing taking place in 6 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 |
|---|---|---|---|---|---|
| Hospira Healthcare | Producer | India | India | CEP, CoA, FDA, GMP, KDMF | 1 products |
| Istituto Biochimico Itali... | Producer | Italy | Italy | CEP, CoA, FDA, GMP | 5 products |
| Mangalam Drugs & Organics... | Producer | India | India | CoA, GMP, WC | 10 products |
| Mylan | Producer | India | India | CoA, GMP, WC | 201 products |
| Osaka Synthetic Chemical ... | Producer | Japan | Japan | CoA, JDMF | 16 products |
| Qilu Tianhe | Producer | China | China | CEP, CoA, GMP, JDMF, USDMF, WC | 16 products |
| Rajasthan Antibiotics | Producer | India | India | CoA, WC | 9 products |
| Sandoz | Producer | Austria | Unknown | CoA, GMP, USDMF | 58 products |
| SETV Global | Producer | India | India | CoA, FDA, GMP | 515 products |
| Shandong Ruiying P.P. | Producer | China | China | CEP, CoA, JDMF, KDMF, USDMF, WC | 1 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 762 products |
| Sterile India | Producer | India | India | CoA, GMP, WC | 13 products |
| USV | Producer | India | India | CoA, JDMF | 35 products |
| Yuhan Chemical | Producer | South Korea | South Korea | CEP, CoA, KDMF, USDMF | 8 products |
When sending a request, specify which Piperacillin 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 Piperacillin 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.
