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Ampicillin acid (Ampicillin) API Manufacturers & Suppliers

17 verified results
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Commercial-scale Suppliers

Distributor
Produced in  China
|

Employees: 50+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
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CEP
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USDMF
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MSDS
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ISO9001

All certificates

GMP
CEP
USDMF
MSDS
ISO9001
CoA
Distributor
Produced in  China
|

Employees: 50+

|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: GMP
|
CEP
|
MSDS
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BSE/TSE
|
ISO9001

All certificates

GMP
CEP
MSDS
BSE/TSE
ISO9001
WC
CoA
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Distributor
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: coa

All certificates

coa
Producer
Produced in  South Korea
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: JDMF
|
CoA

All certificates

JDMF
CoA
Producer
Produced in  Mexico
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: FDA
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CEP
|
coa

All certificates

FDA
CEP
coa
Producer
Produced in  Italy
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
FDA
|
CEP
|
coa

All certificates

GMP
FDA
CEP
coa
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Producer
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: WC
|
CoA

All certificates

WC
CoA
Producer
Produced in  Spain
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Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
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JDMF
|
CoA

All certificates

USDMF
JDMF
CoA
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Producer
Produced in  China
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
CEP
|
USDMF
|
WC
|
JDMF

All certificates

GMP
CEP
USDMF
WC
JDMF
CoA
Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
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ISO 9001
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WC
|
WHO-GMP
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CoA

All certificates

USDMF
ISO 9001
WC
WHO-GMP
CoA
Producer
Produced in  India
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: WC
|
CoA

All certificates

WC
CoA
Producer
Produced in  Unknown
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
FDA
|
CEP
|
USDMF
|
JDMF

All certificates

GMP
FDA
CEP
USDMF
JDMF
coa
Take control of your API sourcing
Submit a Special Inquiry and have Pharmaoffer activate verified suppliers.
Producer
Produced in  China
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: USDMF
|
CoA

All certificates

USDMF
CoA
Producer
Produced in  Italy
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
FDA
|
CEP
|
USDMF
|
coa

All certificates

GMP
FDA
CEP
USDMF
coa
Producer
Produced in  Japan
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: JDMF
|
CoA

All certificates

JDMF
CoA
Producer
Produced in  Italy
|
Audit Report: Click here for more information on Eurofins audit reports
Certifications: GMP
|
USDMF
|
CoA

All certificates

GMP
USDMF
CoA
Not active
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€399,-
All Ampicillin data. Full access. Full negotiation power
Producer
Produced in  South Korea
|
Audit Report: Currently Eurofins has no report for this supplier. Contact them to let them know you're interested!
Certifications: JDMF
|
CoA

All certificates

JDMF
CoA
Not active
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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

AmidesAminopenicillinsAnti-Bacterial AgentsAnti-Infective AgentsAntibacterials for Systemic UseAntiinfectives for Systemic Use
Generic name
Ampicillin
Molecule type
small molecule
CAS number
69-53-4
DrugBank ID
DB00415
Approval status
Approved drug, Vet_approved drug
ATC code
J01CR50

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

Ampicillin (CAS 69-53-4) is a semi-synthetic aminopenicillin used for the systemic treatment of infections caused by susceptible organisms. It retains the core penicillin penam structure and extends activity to selected gram-negative pathogens. Clinically, it is employed in respiratory tract infections, gastrointestinal infections, urinary tract infections, and meningitis caused by organisms such as Escherichia coli, Proteus mirabilis, enterococci, Shigella species, Salmonella species, non‑penicillinase‑producing Neisseria gonorrhoeae, Haemophilus influenzae, and susceptible staphylococci and streptococci.

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

SummaryAmpicillin 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 actionBy 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.
PharmacodynamicsAmpicillin 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
TargetOrganismActions
Penicillin-binding protein 2aStreptococcus pneumoniae (strain ATCC BAA-255 / R6)inhibitor
Penicillin-binding protein 1bStreptococcus pneumoniae (strain ATCC BAA-255 / R6)inhibitor
Penicillin-binding protein 3Streptococcus pneumoniaeinhibitor

ADME / PK

Route of eliminationAmpicillin 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

LifecycleI 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.
MarketsUS, Canada
Supply Chain
Supply chain summaryAmpicillin 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.

SupplierTypeCountryProduct originCertificationsPortfolio
Producer
Italy Italy CEP, CoA, FDA, GMP, USDMF36 products
Producer
Spain Spain CoA, JDMF, USDMF3 products
Distributor
China China BSE/TSE, CEP, CoA, GMP, ISO9001, MSDS, WC250 products
Producer
Germany Italy CoA, GMP, USDMF45 products
Producer
China China CoA, USDMF6 products
Producer
South Korea South Korea CoA, JDMF12 products
Producer
Mexico Mexico CEP, CoA, FDA2 products
Producer
Italy Italy CEP, CoA, FDA, GMP5 products
Producer
Japan Japan CoA, JDMF5 products
Producer
India India CoA, WC9 products
Producer
Austria Unknown CEP, CoA, FDA, GMP, JDMF, USDMF58 products
Producer
China China CoA, WC4 products
Distributor
China China CEP, CoA, GMP, ISO9001, MSDS, USDMF757 products
Producer
India India CoA, ISO9001, USDMF, WC, WHO-GMP13 products
Distributor
China China CoA12 products
Producer
South Korea South Korea CoA, JDMF10 products
Producer
China China CEP, CoA, GMP, JDMF, USDMF, WC12 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.

Frequently asked questions about Ampicillin API


Sourcing

What matters most when sourcing GMP-grade Ampicillin?
Key considerations include confirming GMP-compliant manufacturing and ensuring the API meets US and Canadian regulatory expectations for quality and documentation. Buyers should verify the producer’s track record, including consistent batch quality and reliable supply. Given the mature global market, assessing supply stability and change‑control practices is important.
Which documents are typically required when sourcing Ampicillin API?
Request the core API documentation set: CoA (17 companies), USDMF (8 companies), CEP (7 companies), GMP (7 companies), JDMF (6 companies). Confirm versions and validity dates match the destination market to avoid delays in qualification.
Which manufacturers are known to produce Ampicillin API?
Known or reported manufacturers for Ampicillin: Aurora Industry Co., Ltd, Sinoway industrial Co.,Ltd. Evaluate their GMP history, scale, and regional coverage before requesting dossiers or allocating demand.
How can I request quotes for Ampicillin API from GMP suppliers?
Submit quote requests through the supplier listings with your specs and required documents (specifications, target volume, delivery timeline, and destination). Providing consistent details upfront speeds comparable offers and clarifies technical feasibility.
Is a GMP audit report available for Ampicillin manufacturers?
Audit reports may be requested for Ampicillin: 6 GMP audit reports available. Confirm the scope and recency of any audit before relying on it for qualification decisions.
How many suppliers offer Ampicillin API on Pharmaoffer?
Reported supplier count for Ampicillin: 17 verified suppliers. Filter listings by certifications, regions, and delivery options to match your qualification plan.
Which countries are known to manufacture Ampicillin API?
Production countries reported for Ampicillin: China (6 producers), Italy (3 producers), India (2 producers). Knowing the manufacturing geography helps anticipate logistics lead times and import compliance needs.
Which certifications do suppliers of Ampicillin usually hold?
Common certifications for Ampicillin suppliers: CoA (17 companies), USDMF (8 companies), CEP (7 companies), GMP (7 companies), JDMF (6 companies). Always verify issuing authorities and expiry dates when reviewing audit packages.

Technical

What is Ampicillin (CAS 69-53-4) used for?
Ampicillin is used for systemic treatment of infections caused by susceptible gram‑positive and gram‑negative organisms. It is employed in respiratory, gastrointestinal, and urinary tract infections, as well as meningitis due to pathogens such as E. coli, Proteus mirabilis, enterococci, Shigella, Salmonella, non‑penicillinase‑producing N. gonorrhoeae, H. influenzae, and susceptible staphylococci and streptococci. Its activity is mediated by inhibition of bacterial cell wall synthesis, leading to bactericidal effects.
Which therapeutic class does Ampicillin fall into?
Ampicillin belongs to the following therapeutic categories: Amides, Aminopenicillins, Anti-Bacterial Agents, Anti-Infective Agents, Antibacterials for Systemic Use. This positioning helps teams compare alternative APIs, anticipate pharmacology expectations, and align early research priorities.
What conditions is Ampicillin mainly prescribed for?
The primary indications for Ampicillin: 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. These use cases frame the target patient populations and help prioritize formulation and safety evaluations.
How does Ampicillin work?
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.
What should someone know about the safety or toxicity profile of Ampicillin?
Ampicillin’s safety profile is characterized mainly by hypersensitivity reactions typical of beta‑lactams, which can range from mild rash to severe anaphylaxis. Gastrointestinal disturbances and disruption of normal flora may occur. In patients with renal impairment, reduced clearance can lead to elevated serum levels and an increased risk of neurotoxicity, so dose adjustment is usually required. Cross‑contamination controls are important when handling the API due to beta‑lactam allergenicity.
What are important formulation and handling considerations for Ampicillin as an API?
Ampicillin’s hydrophilicity supports aqueous formulation, but its beta‑lactam ring is unstable in solution, so parenteral products are supplied as dry powders for reconstitution. Reconstituted solutions require controlled pH and prompt use to limit hydrolysis. Oral formulations may need protection from gastric degradation and are typically administered on an empty stomach to support absorption. Because the drug is eliminated largely unchanged in urine, no special metabolic considerations affect formulation.
Is Ampicillin a small molecule?
Ampicillin is classified as a small molecule. That classification shapes process design, impurity profiling, and analytical control strategies.
Are there special stability concerns for oral Ampicillin?
Oral Ampicillin is susceptible to degradation in the acidic environment of the stomach, so formulations may need protection from gastric acid. It is generally taken on an empty stomach to support absorption and reduce acid‑related breakdown. Once in solution, the drug is chemically unstable, but this primarily affects reconstituted products rather than solid oral forms.

Regulatory

Where is Ampicillin approved or in use globally?
Ampicillin is reported as approved in the following major regions: US, Canada. Understanding geographic coverage informs regulatory filings, supply planning, and risk assessments before escalating procurement.

Pharmaoffer

How does Pharmaoffer’s Smart Sourcing Service help with Ampicillin procurement?
Pharmaoffer's Smart Sourcing Service coordinates compliant suppliers, documentation, and competitive quotes for Ampicillin. It centralizes outreach, follow-ups, and document validation to shorten procurement timelines.
Is Ampicillin included in the PRO Data Insights coverage?
PRO Data Insights coverage for Ampicillin: 4402 verified transactions across 943 suppliers and 561 buyers worldwide. Use the dataset to benchmark suppliers and monitor regulatory activity where available.
Where can I access the API market report for Ampicillin?
Market report availability for Ampicillin: Report Available. The report highlights demand trends, pricing drivers, and supplier landscape insights for procurement planning.