Amoxycillin & Potassium Clavulanate

The combination of Amoxycillin and Potassium Clavulanate represents one of the most commonly prescribed and clinically effective broad-spectrum antibiotic therapies worldwide. This synergistic formula is highly effective in treating bacterial infections that are resistant to standard penicillin-based treatments. By combining Amoxycillin, a beta-lactam antibiotic, with Clavulanate, a potent beta-lactamase inhibitor, this combination expands the antimicrobial spectrum and enhances therapeutic outcomes.

BluepillExpress, an established pharmaceutical manufacturer and global exporter, offers high-quality third-party manufacturing services for Amoxycillin & Potassium Clavulanate formulations across multiple dosage forms. With certified production facilities and a commitment to international compliance, we ensure that our clients receive world-class products tailored to their market requirements.

About BluepillExpress

BluepillExpress is a WHO-GMP and ISO 9001:2015 certified pharmaceutical manufacturer providing contract manufacturing, private label services, and global export of generic and branded medications. We specialize in oral and injectable formulations across various therapeutic segments including anti-infectives, cardiovascular drugs, gastrointestinal agents, and nutraceuticals.

Our end-to-end manufacturing services are designed to support pharmaceutical brands, hospital supply chains, tender-based organizations, and international distributors. With high production capacity, regulatory expertise, and market-driven formulations, BluepillExpress is the ideal partner for manufacturing Amoxycillin and Clavulanate combinations.

Pharmacological Classification

• Therapeutic Class: Broad-spectrum Antibiotic
• Pharmacological Category: Beta-lactam Penicillin + Beta-lactamase Inhibitor
• Primary Indication: Treatment of bacterial infections caused by beta-lactamase producing organisms

Mechanism of Action

• Amoxycillin works by inhibiting bacterial cell wall synthesis, leading to cell lysis and death. It is bactericidal in nature and effective against a range of Gram-positive and some Gram-negative organisms.
• Potassium Clavulanate blocks beta-lactamase enzymes that certain bacteria produce to resist amoxicillin. By inhibiting this enzyme, clavulanate protects amoxicillin from degradation and enhances its antimicrobial spectrum.

This dual mechanism makes the combination highly effective against resistant strains of bacteria, increasing treatment efficacy and reducing the likelihood of clinical failure.

Dosage Forms Available for Manufacturing

At BluepillExpress, we offer manufacturing for a wide range of Amoxycillin & Clavulanate dosage forms to meet varying patient needs and market preferences:

1. Tablets
   • Amoxycillin 500 mg + Clavulanate 125 mg
   • Amoxycillin 875 mg + Clavulanate 125 mg
   • Film-coated or uncoated
   • Standard or dispersible
2. Dry Syrup / Powder for Oral Suspension
   • Amoxycillin 200 mg + Clavulanate 28.5 mg per 5 ml
   • Amoxycillin 400 mg + Clavulanate 57 mg per 5 ml
   • Child-friendly flavors (orange, strawberry, banana)
   • Sugar-free variants available
3. Injections (Dry Powder)
   • Amoxycillin 1 gm + Clavulanate 200 mg (IV/IM)
   • Supplied with sterile water ampoule upon request
4. Capsules
   • Custom strengths as per client requirement

Clinical Indications

This combination is commonly prescribed for the treatment of infections such as:

• Upper and lower respiratory tract infections (sinusitis, bronchitis, pneumonia)
• Skin and soft tissue infections
• Urinary tract infections (UTIs)
• Otitis media
• Dental infections
• Bone and joint infections
• Gynecological infections

Its enhanced activity against beta-lactamase-producing pathogens makes it a preferred choice in recurrent or persistent infections.

Manufacturing Infrastructure at BluepillExpress

BluepillExpress operates state-of-the-art pharmaceutical manufacturing units, compliant with the latest international quality and safety norms.

Key Features of Our Infrastructure:

• Separate air-handling units for each dosage form to prevent cross-contamination
• Automated granulation, blending, compression, and coating machines for tablet production
• Fully integrated dry powder syrup filling and sealing lines
• Lyophilization and dry powder filling systems for injectables
• WHO-GMP Class 100,000 cleanroom environment
• In-house analytical and microbiology laboratories

Our systems support the production of over 10 million tablets and 5 million dry syrup bottles per month, enabling scalability and reliability for any volume requirement.

Quality Assurance and Compliance

At BluepillExpress, we ensure that every batch of Amoxycillin & Clavulanate formulation passes through rigorous quality control and quality assurance protocols, including:

• Raw material and excipient validation
• In-process checks for weight, uniformity, hardness, and disintegration
• Microbial testing (Total Bacterial Count, Yeast & Mold, Pathogens)
• Potency assays and HPLC analysis
• Endotoxin and pyrogen testing for injectables
• Stability studies in real-time and accelerated conditions (ICH guidelines)

We ensure complete traceability, batch records, and regulatory documentation, supporting both domestic sales and international registrations.

Packaging Options and Label Customization

We provide a wide variety of packaging formats to suit different market needs and regional preferences:

• Blister packs (PVC/Alu or Alu/Alu) for tablets
• Amber glass or PET bottles for dry syrups (with child-resistant caps and measuring spoons)
• Sterile vials for injections (optional inclusion of sterile water)
• Multicolor printed cartons and leaflets

Clients may opt for fully customized private-label packaging, including:

• Multilingual labels
• Brand-specific color schemes
• Regulatory-compliant label design (US FDA, EMA, SFDA, etc.)

Regulatory and Export Documentation Support

BluepillExpress assists with complete documentation required for international market registration and bulk tenders. Documents provided include:

• WHO-GMP Certificate
• Certificate of Pharmaceutical Product (COPP)
• Certificate of Analysis (COA)
• Certificate of Origin
• Stability data (on request)
• Master formula and product dossiers
• MSDS (Material Safety Data Sheets)
• Free Sale Certificate

We have experience in exporting to:

• African nations (Nigeria, Kenya, Ethiopia, Ghana)
• Southeast Asia (Vietnam, Myanmar, Philippines)
• CIS (Kazakhstan, Georgia, Uzbekistan)
• Latin America
• Middle East and GCC countries

Private Label and Third-Party Manufacturing Process

Our streamlined process ensures fast and efficient execution for your product:

1. Client Consultation – Understanding formulation, dosage form, market destination, and regulatory requirements
2. Quotation and Agreement – Sharing product specs, MOQ, price structure, and packaging options
3. Formulation and Production – Sourcing high-purity APIs and manufacturing under strict quality protocols
4. Labeling and Packaging – Designing and printing brand-specific packaging
5. Dispatch and Documentation – Global shipping with all regulatory documentation included

Our dedicated product managers ensure transparent communication and real-time updates throughout the manufacturing process.

Client Segments We Serve

Our Amoxycillin & Potassium Clavulanate manufacturing services cater to:

• Generic pharmaceutical companies
• Hospital and institutional buyers
• Retail pharmacy brands
• Government and NGO tenders
• Online pharmaceutical stores
• Private-label supplement companies

Sustainability and Ethical Commitment

BluepillExpress integrates sustainable practices and ethical standards throughout our operations, including:

• Environmentally responsible waste management
• Energy-efficient manufacturing processes
• Responsible sourcing of raw materials
• Zero child labor policy and fair working conditions
• Support for recyclable and biodegradable packaging

Advantages of Partnering with BluepillExpress

• WHO-GMP certified and internationally compliant manufacturing
• End-to-end third-party manufacturing with global export support
• Small batch and bulk order flexibility
• Competitive pricing and timely delivery
• Full-spectrum regulatory and documentation assistance
• Complete confidentiality and brand protection

Conclusion

Amoxycillin & Potassium Clavulanate is a cornerstone of modern antibacterial therapy, offering effective treatment for a wide range of bacterial infections with proven safety and clinical success. Its versatility and broad-spectrum action make it one of the most in-demand products in both domestic and international pharmaceutical markets.

BluepillExpress stands at the forefront of pharmaceutical manufacturing, offering customizable, compliant, and scalable production solutions for this powerful combination. Whether you are looking to launch a new brand, expand your antibiotic range, or enter new markets, BluepillExpress is equipped to deliver products that reflect trust, efficacy, and global standards.