Amoxicillin Injection BP

Amoxicillin, a semi-synthetic derivative of penicillin, is one of the most widely prescribed antibiotics globally. It belongs to the β-lactam class and is highly effective against a broad range of Gram-positive and Gram-negative bacteria. While commonly administered orally, Amoxicillin Injection BP plays a crucial role in treating severe infections or situations requiring rapid therapeutic action, such as when oral administration is impractical.

At BluepillExpress, we offer third-party manufacturing services for Amoxicillin Injection BP, providing high-quality, GMP-compliant, and export-ready injectable antibiotic formulations. Our dedicated infrastructure, stringent quality control systems, and global regulatory expertise make us the preferred partner for healthcare companies looking to outsource the manufacturing of critical care antibiotics.

Therapeutic Indications

Amoxicillin Injection BP is indicated for the treatment of various bacterial infections, including:

• Respiratory Tract Infections (e.g., pneumonia, bronchitis)
• Urinary Tract Infections (e.g., cystitis, pyelonephritis)
• Skin and Soft Tissue Infections
• Ear, Nose, and Throat Infections (e.g., otitis media, sinusitis)
• Gastrointestinal Infections (e.g., typhoid fever, bacterial enteritis)
• Septicemia and Bacteremia
• Prophylaxis in Surgical Procedures

This formulation is particularly useful in hospital settings or in patients who are unable to tolerate oral medications.

Composition and Strengths

Amoxicillin Injection BP is formulated as a sterile powder for reconstitution and is available in various strengths, including:

• 250 mg/vial
• 500 mg/vial
• 1 g/vial
• 2 g/vial

These can be reconstituted with sterile water or appropriate diluents and administered via intramuscular (IM) or intravenous (IV) routes, depending on the clinical requirement.

Mechanism of Action

Amoxicillin acts by inhibiting the bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) within the bacterial cell wall, interfering with peptidoglycan cross-linking which is essential for wall structural integrity. This action results in bacterial cell lysis and death, making it bactericidal in nature.

It is effective against a wide spectrum of bacteria, including Streptococcus spp., Staphylococcus spp. (non-β-lactamase producing), Escherichia coli, Haemophilus influenzae, Proteus mirabilis, and many others.

Why Choose BluepillExpress for Amoxicillin Injection BP Manufacturing?

BluepillExpress stands out as a premier third-party manufacturer and global exporter of pharmaceutical injectables, including beta-lactam antibiotics like Amoxicillin Injection BP. Here’s why clients choose us:

1. WHO-GMP & ISO Certified Manufacturing Facilities

Our dedicated beta-lactam manufacturing units are:

• Equipped with modular cleanrooms and HEPA filtration
• Operated under strict aseptic conditions
• Certified by WHO-GMP, ISO 9001:2015, ISO 14001, and ISO 45001

2. Sterile Manufacturing Expertise

We specialize in sterile injectable formulations using:

• Automated vial washing and depyrogenation tunnels
• Laminar airflow filling lines
• Lyophilization facilities (where applicable)
• Steam sterilization and dry heat sterilization

3. End-to-End Customization

We offer:

• Customizable strengths and pack sizes
• Contract and private label manufacturing
• Bulk and small-batch production runs
• Regulatory file support for global markets

4. Strict Quality Control and Assurance

Every batch is subjected to stringent quality checks such as:

• Sterility testing
• Pyrogen testing
• pH and particulate matter analysis
• Assay and degradation profiling
• Container integrity testing

All testing is done in-house in our fully equipped Quality Control laboratories.

Formulation and Packaging Options

Formulation Type:

• Sterile powder for injection, suitable for IM or IV administration
• Can be co-formulated with Clavulanic Acid for enhanced β-lactamase resistance upon request

Packaging Options:

• Glass vials (Type I USP/Ph.Eur compliant)
• Flip-off seals and rubber stoppers
• Individual cartons with leaflet inserts
• Available in 1’s, 10’s, and hospital packs
• Custom packaging design and branding available for private label partners

Compliance and Regulatory Support

At BluepillExpress, we ensure full compliance with local and international regulatory requirements. Our team provides:

• Certificate of Analysis (COA)
• Batch Manufacturing Record (BMR)
• Method of Analysis (MOA)
• Stability Data and Validation Reports
• MSDS and Technical Data Sheets
• Dossiers for product registration (CTD/eCTD format)

We work closely with regulatory authorities in Asia, Africa, the Middle East, CIS, and Latin America to ensure smooth and compliant product registration.

Export-Ready Injectable Antibiotics

BluepillExpress is a recognized global exporter of injectable pharmaceuticals, currently serving over 40 countries. Our Amoxicillin Injection BP is manufactured with export quality standards and is supplied to:

• Government health ministries
• Private and public hospitals
• Pharmaceutical distributors
• Tender suppliers
• Emergency care providers and NGOs

We ensure timely delivery, cold chain logistics (if required), and complete documentation to facilitate hassle-free import clearance.

Applications Across Various Sectors

Our Amoxicillin Injection BP is widely used across multiple healthcare segments:

• Clinical and Hospital Use: Emergency infections, pre- and post-operative prophylaxis
• Veterinary Applications: Available upon request as per region-specific guidelines
• Disaster Relief and Emergency Stock: Shelf-stable for stockpiling
• Military and Government Health Programs

R&D and Innovation

Our in-house Research and Development team constantly works on:

• Enhancing the stability and shelf-life of beta-lactam injectables
• Developing combination formulations such as Amoxicillin + Clavulanic Acid
• Innovating vial fill-finish techniques to ensure precision and sterility
• Exploring advanced packaging for increased product safety

We also develop bioequivalence (BE) studies, stability testing under ICH guidelines, and analytical method development for global markets.

Sustainability and Safety

At BluepillExpress, we prioritize environmentally responsible manufacturing and worker safety:

• Effluent Treatment Plants (ETP) for safe waste disposal
• Closed containment systems for handling penicillin derivatives
• Zero-discharge facilities
• Training and PPE protocols for our staff to avoid cross-contamination and allergic sensitization

Private Labeling and Contract Manufacturing Services

Whether you’re a pharmaceutical startup or an established brand, we offer comprehensive private labeling services, including:

• Brand name development
• Artwork and packaging design
• Product documentation and brochures
• Sample kits and demo vials
• MOQ-based pricing for startups and tender bidders

We ensure confidentiality and IP protection in all contract manufacturing agreements.

Storage and Shelf Life

• Storage Conditions: Store below 25°C in a dry place, protect from light
• Shelf Life: Typically 24 to 36 months, depending on formulation and packaging

We provide full stability data under Zone II, III, and IV conditions to support international registrations.

Conclusion

Amoxicillin Injection BP continues to be a cornerstone antibiotic in global healthcare, thanks to its broad-spectrum activity and clinical reliability. With the rise in antimicrobial resistance and increasing demand for hospital-ready injectable antibiotics, sourcing from a trusted third-party manufacturer is more important than ever.

BluepillExpress brings together scientific excellence, regulatory knowledge, and world-class manufacturing to deliver safe, effective, and export-ready Amoxicillin Injection BP to pharmaceutical companies, governments, and global healthcare partners.