Amoxicillin Injection BP

Amoxicillin Injection BP is a widely used beta-lactam antibiotic belonging to the penicillin group. It is commonly prescribed to treat various bacterial infections, ranging from respiratory tract infections to urinary tract and skin infections. The injectable form ensures rapid therapeutic action, especially in moderate to severe infections, when oral administration is not feasible.

As the global healthcare industry seeks effective, broad-spectrum injectable antibiotics with reliable quality assurance, BluepillExpress offers top-tier third-party manufacturing services for Amoxicillin Injection BP. Our facilities are internationally certified, fully compliant with Good Manufacturing Practices (GMP), and equipped to manufacture Amoxicillin Injection in bulk for global markets.

Product Overview – What is Amoxicillin Injection BP?

Amoxicillin, a semi-synthetic derivative of penicillin, acts by inhibiting bacterial cell wall synthesis, making it effective against a broad range of Gram-positive and Gram-negative bacteria. The injectable version is particularly useful in hospitals, emergency rooms, and critical care settings where immediate drug action is required.

Pharmacological Class: Beta-Lactam Antibiotic
Mechanism of Action: Inhibits bacterial transpeptidase enzymes involved in cell wall synthesis
Therapeutic Use: Bactericidal
Route of Administration: Intramuscular (IM) / Intravenous (IV)

Common Indications:

• Lower and upper respiratory tract infections
• Ear, nose, and throat infections
• Urinary tract infections
• Skin and soft tissue infections
• Bone and joint infections
• Septicemia
• Post-surgical infections and prophylaxis

Why Choose BluepillExpress for Amoxicillin Injection Manufacturing?

At BluepillExpress, we combine expertise, advanced infrastructure, and a commitment to excellence to deliver high-quality injectable antibiotics for clients worldwide. Our third-party manufacturing services provide:

• WHO-GMP and ISO Certified Facilities
• Strict Adherence to British Pharmacopoeia (BP) Standards
• Sterile Manufacturing Units with Cleanroom Technology
• Validated Processes and Batch-to-Batch Consistency
• Export-Ready Products with Full Regulatory Dossiers

We understand the high standards required for parenteral drugs, and we operate with complete transparency, offering documentation, quality testing, and support from formulation to dispatch.

Technical Specifications

Drug Name: Amoxicillin
Formulation Type: Sterile Powder for Reconstitution
Strengths Available:

• Amoxicillin 250 mg Injection BP
• Amoxicillin 500 mg Injection BP
• Amoxicillin 1 g Injection BP

Pharmacopoeial Compliance: British Pharmacopoeia (BP)
Shelf Life: 24–36 months (as per packaging and storage conditions)
Dosage Form: Injectable vial with sterile powder for IM/IV reconstitution
Pack Type: Glass vial with rubber stopper, sealed with aluminum flip-off cap
Optional Add-ons: WFI (Water for Injection) ampoule, if required

Composition

Each vial contains:

• Active Ingredient: Amoxicillin sodium equivalent to 250 mg / 500 mg / 1 g of Amoxicillin base
• Excipients: Sterile agents and stabilizers (as per BP standard)

All ingredients are sourced from qualified vendors with validated Certificates of Analysis (COA). Our formulations ensure optimal stability, potency, and compatibility for medical use.

Manufacturing Process

We follow stringent aseptic processing methods for the production of injectable formulations. Our process includes:

1. Raw Material Procurement: Amoxicillin sodium is procured from approved API vendors after rigorous quality testing.
2. Sterile Blending: Blending of API and excipients is performed under controlled cleanroom environments.
3. Filling and Sealing: Automated vial filling and rubber stoppering machines operate in ISO Class 5 environments.
4. Terminal Sterilization: Vials are sterilized using validated autoclaving or filtration methods to ensure sterility.
5. Labeling and Packaging: Automated packaging lines handle label application, secondary carton packing, and serialization.
6. In-Process Quality Control: Every batch undergoes microbial testing, sterility testing, weight variation, and potency assay.

All stages of production comply with cGMP guidelines and meet British Pharmacopoeia specifications.

Packaging & Customization Options

We offer flexible packaging solutions tailored to client requirements. Options include:

• Single Vial Packs: With or without Water for Injection
• Hospital Bulk Packs: For institutional supply
• Multilingual Labeling: Customized as per the target country
• Tamper-Proof Packaging: With hologram security features (on request)
• Export-Ready Shipments: With outer cartons suitable for international transit

Each batch comes with comprehensive batch documentation, COA, and stability data to support global marketing and distribution.

Regulatory Support and Documentation

We offer full regulatory assistance for product registration and marketing across various geographies. Our documentation support includes:

• Certificate of Analysis (COA)
• Certificate of Pharmaceutical Product (COPP)
• Drug Master File (DMF) / Product Dossier
• Stability Reports (Zone II/III/IV available)
• Method of Analysis (MOA)
• GMP Certificate, ISO, and Free Sale Certificates
• Clinical Data (upon request and availability)

Our regulatory team ensures smooth approvals with FDA, EMA, TGA, MHRA, and WHO PQ requirements where applicable.

Quality Control and Assurance

Quality is the cornerstone of our operations at BluepillExpress. Every batch of Amoxicillin Injection BP undergoes rigorous in-house and third-party testing to ensure:

• Sterility
• pH Range Compliance
• Endotoxin Limits
• Particulate Matter Testing
• Assay for Active Content (within BP limits)
• Moisture Content and Residual Solvents

Our fully equipped QC laboratories utilize advanced equipment such as HPLC, FTIR, UV Spectrophotometer, and Microbial Testing Chambers. Stability testing under ICH guidelines guarantees product integrity throughout the shelf life.

Therapeutic Advantages of Amoxicillin Injection BP

• Rapid Onset: Effective in acute infections where oral dosing is insufficient
• High Bioavailability: Ensures fast bloodstream absorption
• Broad-Spectrum Activity: Covers Streptococci, E. coli, H. influenzae, and more
• Low Resistance Profile: Especially when administered under proper supervision
• Minimal Side Effects: Well-tolerated and widely accepted in clinical settings

Amoxicillin injection is an essential medicine on the WHO Model List of Essential Medicines and continues to be a vital antibiotic in hospital formularies worldwide.

Target Markets and Applications

We serve healthcare providers, government health programs, hospitals, wholesalers, and pharmaceutical companies globally. Amoxicillin Injection BP is highly demanded in:

• Hospitals and Clinics
• Public Health Programs
• NGO & Relief Agency Supplies
• Tender-Based Government Procurement
• Pharmacy and Emergency Medical Services (EMS)
• International Humanitarian Aid Projects

Our manufacturing and export capabilities make us a preferred partner for institutional supply, tenders, and private-label distribution.

Global Export Reach

BluepillExpress is a trusted global exporter of injectable antibiotics, with established client bases in:

• Africa: Kenya, Nigeria, Ghana, Ethiopia
• Middle East: Saudi Arabia, UAE, Oman, Iraq
• Asia-Pacific: Sri Lanka, Vietnam, Philippines, Bangladesh
• CIS Countries: Kazakhstan, Uzbekistan, Armenia
• Latin America and Caribbean: Dominican Republic, Bolivia, Peru
• Oceania and Small Island Nations: Fiji, Papua New Guinea

We ensure efficient logistics, compliance with destination country regulations, and reliable delivery timelines.

Why Partner with BluepillExpress?

• Trusted Pharmaceutical Manufacturing Brand
• WHO-GMP Compliant Infrastructure
• Low Minimum Order Quantity (MOQ) for Startups
• Private Label and Bulk Supply Options
• Custom Documentation for Regulatory Approvals
• Dedicated Project Managers for Every Client
• Timely Dispatch with International Logistics Network