Ampicillin acid (Ampicillin) API Manufacturers & Suppliers
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Ampicillin | CAS No: 69-53-4 | GMP-certified suppliers
A medication that treats respiratory, gastrointestinal, urinary tract infections and meningitis caused by susceptible bacteria, supporting reliable supply needs for broad infection management.
Therapeutic categories
Primary indications
- For treatment of infection (Respiratory, GI, UTI and meningitis) due to E
- Coli, P
- Mirabilis, enterococci, Shigella, S
- Typhosa and other Salmonella, nonpenicillinase-producing N
Product Snapshot
- Ampicillin is an oral and parenteral small‑molecule beta‑lactam antibiotic available in multiple solid, liquid, and injectable formulations
- It is used for a range of bacterial infections including respiratory, gastrointestinal, urinary tract, and central nervous system infections caused by susceptible organisms
- It is approved for human and veterinary use in the US and Canada
Clinical Overview
The pharmacologic activity of ampicillin is bactericidal. It exhibits in vitro activity against gram-positive and gram-negative organisms under aerobic and anaerobic conditions. Its mechanism involves binding to penicillin-binding proteins and inhibiting the terminal stages of bacterial cell wall synthesis. Resulting structural instability triggers autolytic enzyme activity and leads to cell lysis. Ampicillin shows stability against hydrolysis by several beta‑lactamases, including penicillinases, cephalosporinases, and extended spectrum beta‑lactamases, although resistance patterns vary by region and organism.
After oral administration, absorption is moderate and can be influenced by gastrointestinal conditions. Distribution extends to various tissues and fluids, including inflamed meninges. The compound is mainly eliminated unchanged via renal excretion, and clearance is reduced in renal impairment. Dose adjustments are typically required in patients with significantly decreased renal function.
Safety considerations include hypersensitivity reactions associated with beta‑lactams, ranging from rash to anaphylaxis. Gastrointestinal disturbances and alterations of normal flora may occur. High serum concentrations in patients with renal dysfunction may increase the risk of neurotoxicity.
Ampicillin is available globally in multiple generic formulations for human and veterinary use. When procuring the active pharmaceutical ingredient, sourcing teams should confirm compliance with applicable pharmacopeial standards, control of beta‑lactam cross‑contamination risks, and supplier capability for consistent impurity and microbiological quality management.
Identification & chemistry
| Generic name | Ampicillin |
|---|---|
| Molecule type | Small molecule |
| CAS | 69-53-4 |
| UNII | 7C782967RD |
| DrugBank ID | DB00415 |
Pharmacology
| Summary | Ampicillin is a beta‑lactam antibiotic that exerts bactericidal activity by binding to multiple penicillin‑binding proteins and blocking the final steps of bacterial cell wall synthesis. The resulting structural defects promote autolysin‑mediated cell lysis in susceptible gram‑positive and gram‑negative organisms. Its pharmacologic profile includes stability against several beta‑lactamases and engagement of transporters involved in cellular uptake. |
|---|---|
| Mechanism of action | By binding to specific penicillin-binding proteins (PBPs) located inside the bacterial cell wall, Ampicillin 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 Ampicillin interferes with an autolysin inhibitor. |
| Pharmacodynamics | Ampicillin 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. Ampicillin has <i>in vitro</i> activity against gram-positive and gram-negative aerobic and anaerobic bacteria. The bactericidal activity of Ampicillin results from the inhibition of cell wall synthesis and is mediated through Ampicillin binding to penicillin binding proteins (PBPs). Ampicillin 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 2a | Streptococcus pneumoniae (strain ATCC BAA-255 / R6) | inhibitor |
| Penicillin-binding protein 1b | Streptococcus pneumoniae (strain ATCC BAA-255 / R6) | inhibitor |
| Penicillin-binding protein 3 | Streptococcus pneumoniae | inhibitor |
ADME / PK
| Route of elimination | Ampicillin is excreted largely unchanged in the urine. |
|---|
Formulation & handling
- Suitable for both oral and parenteral formulations; oral products may require protection from gastric degradation and are typically taken on an empty stomach to optimize absorption.
- As a hydrophilic small‑molecule beta‑lactam, it dissolves readily in aqueous vehicles but is chemically unstable in solution, so injectable forms are commonly supplied as dry powders for reconstitution.
- Reconstituted solutions show limited stability and require controlled pH and prompt use to prevent beta‑lactam hydrolysis.
Regulatory status
| Lifecycle | I can draft the summary, but I need the patent‑expiry timing (or at least whether key patents have expired or are upcoming). Please provide the patent‑expiry information for the API, and I’ll generate the 1–2 sentence lifecycle summary. |
|---|
| Markets | US, Canada |
|---|
Supply Chain
| Supply chain summary | Ampicillin has a long-established manufacturing base, with multiple historic originator companies and a broad group of current producers contributing to global supply. The product is widely available in major markets, including the US and Canada, reflecting its long-standing presence as a standard antimicrobial. Patent expiry occurred decades ago, so mature and extensive generic competition is already present. |
|---|
Ampicillin 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.
Ampicillin (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.
Ampicillin API manufacturers & distributors
Compare qualified Ampicillin API suppliers worldwide. We currently have 17 companies offering Ampicillin 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 |
|---|---|---|---|---|---|
| ACS Dobfar | Producer | Italy | Italy | CEP, CoA, FDA, GMP, USDMF | 36 products |
| Antibióticos De León | Producer | Spain | Spain | CoA, JDMF, USDMF | 3 products |
| Aurora Industry Co., Ltd | Distributor | China | China | BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, WC | 250 products |
| Corden Pharma | Producer | Germany | Italy | CoA, GMP, USDMF | 45 products |
| CSPC Zhongnuo | Producer | China | China | CoA, USDMF | 6 products |
| Daewoong Bio | Producer | South Korea | South Korea | CoA, JDMF | 12 products |
| Fersinsa Gb | Producer | Mexico | Mexico | CEP, CoA, FDA | 2 products |
| Istituto Biochimico Itali... | Producer | Italy | Italy | CEP, CoA, FDA, GMP | 5 products |
| Meiji Seika | Producer | Japan | Japan | CoA, JDMF | 5 products |
| Rajasthan Antibiotics | Producer | India | India | CoA, WC | 9 products |
| Sandoz | Producer | Austria | Unknown | CEP, CoA, FDA, GMP, JDMF, USDMF | 58 products |
| Shandong Lukang | Producer | China | China | CoA, WC | 4 products |
| Sinoway industrial Co.,Lt... | Distributor | China | China | CEP, CoA, GMP, ISO9001, MSDS, USDMF | 757 products |
| Sterile India | Producer | India | India | CoA, ISO9001, USDMF, WC, WHO-GMP | 13 products |
| United Pharma Industries ... | Distributor | China | China | CoA | 12 products |
| Yungjin Pharmaceutical | Producer | South Korea | South Korea | CoA, JDMF | 10 products |
| Zhuhai United Labs | Producer | China | China | CEP, CoA, GMP, JDMF, USDMF, WC | 12 products |
When sending a request, specify which Ampicillin 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 Ampicillin 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.
