Amoxicillin and Potassium Clavulanate is a widely used, clinically proven combination of a broad-spectrum penicillin antibiotic and a beta-lactamase inhibitor. This synergistic duo has transformed the management of bacterial infections by overcoming resistance from beta-lactamase-producing pathogens. The combination is prescribed across the globe for treating respiratory tract infections, urinary tract infections, skin infections, and more.
At BluepillExpress, we provide high-quality third-party manufacturing services for Amoxicillin and Potassium Clavulanate in oral and injectable dosage forms. Manufactured in WHO-GMP and ISO-certified facilities, our products meet global regulatory standards, serving clients in both domestic and international markets.
What is Amoxicillin and Potassium Clavulanate?
This combination contains:
- Amoxicillin – a semi-synthetic penicillin with broad-spectrum antibacterial activity
- Clavulanic Acid (as Potassium Clavulanate) – a beta-lactamase inhibitor that protects amoxicillin from enzymatic degradation
The result is a potent antibiotic combination capable of treating infections caused by beta-lactamase producing strains, making it especially useful in resistant and recurrent infections.
Therapeutic Class: Beta-lactam/Beta-lactamase inhibitor combination
Mechanism of Action: Amoxicillin inhibits bacterial cell wall synthesis, while clavulanate blocks beta-lactamase enzymes
Route of Administration: Oral (Tablets, Dry Syrup), Injectable (on request)
Clinical Applications and Indications
Amoxicillin and Potassium Clavulanate is approved for the treatment of a wide range of infections, especially those caused by beta-lactamase-producing bacteria.
Common Indications Include:
- Upper and lower respiratory tract infections
- Acute bacterial sinusitis
- Otitis media (middle ear infections)
- Urinary tract infections
- Skin and soft tissue infections
- Dental infections (abscesses, periodontitis)
- Bone and joint infections
- Infections caused by resistant Staphylococcus aureus, Haemophilus influenzae, E. coli, and Klebsiella species
Its broad-spectrum coverage, excellent tissue penetration, and resistance-fighting mechanism make it a frontline therapy worldwide.
Why Choose BluepillExpress for Manufacturing?
At BluepillExpress, we combine pharmaceutical excellence with international standards to provide fully integrated third-party and contract manufacturing services. Whether you’re a startup, distributor, or established pharma brand, we deliver high-quality antibiotic formulations tailored to your market.
Key Advantages:
- WHO-GMP, ISO 9001:2015, and FSSAI certified facilities
- Dedicated beta-lactam manufacturing area
- Regulatory compliance with BP, USP, and IP standards
- Customized packaging and private labeling
- Low MOQ and scalable production
- Global documentation and export support
We bring together cutting-edge technology, skilled manpower, and quality systems to ensure that your brand delivers value, trust, and therapeutic excellence.
Product Range and Dosage Forms
We manufacture Amoxicillin and Potassium Clavulanate in various strengths and forms for pediatric and adult use.
Oral Solid Dosage Forms (Tablets)
- Amoxicillin 500 mg + Clavulanate 125 mg Tablets
- Amoxicillin 875 mg + Clavulanate 125 mg Tablets
Oral Suspension (Dry Syrup)
- Amoxicillin 200 mg + Clavulanate 28.5 mg per 5 ml
- Amoxicillin 400 mg + Clavulanate 57 mg per 5 ml
Injectable Form (on demand)
- Amoxicillin 1.2 g (1000 mg + 200 mg) for IV/IM use
All products are customizable based on client requirements, including taste-masking, sugar-free options, and pediatric-friendly flavors.
Composition and Ingredients
We use pharma-grade APIs and excipients sourced from certified suppliers. Each batch undergoes rigorous quality checks.
Tablet Composition (Example: 625 mg)
- Active Ingredients:
- Amoxicillin Trihydrate IP equivalent to 500 mg Amoxicillin
- Potassium Clavulanate IP equivalent to 125 mg Clavulanic Acid
- Excipients: Magnesium stearate, colloidal silicon dioxide, sodium starch glycolate, film coating material, etc.
Dry Syrup Composition (Example: 400 mg/57 mg)
- Active Ingredients:
- Amoxicillin Trihydrate equivalent to 400 mg Amoxicillin per 5 ml
- Potassium Clavulanate equivalent to 57 mg Clavulanic Acid per 5 ml
- Excipients: Sucrose, flavoring agents, suspending agents, preservatives
Flavored variants (banana, orange, strawberry) can be developed as per market preference.
Manufacturing Process Overview
Our manufacturing process is compliant with GMP and ICH guidelines, with strong emphasis on sterility, stability, and batch uniformity.
- Raw Material Inspection: Testing for identity, purity, and compliance
- Granulation & Blending: Controlled granulation for optimal flow and compressibility
- Compression & Coating: Tablets are compressed and coated using automated high-speed machines
- Dry Syrup Filling: Measured filling into HDPE bottles with moisture control
- Packaging & Labeling: Blister or bottle packaging with batch traceability and barcode support
- In-process and Final QC: Assay, dissolution, microbial load, and stability testing
Our dedicated beta-lactam facilities ensure zero cross-contamination, maintaining integrity across production.
Packaging and Branding
We offer complete packaging customization to align with your brand identity and target market.
Tablets:
- Blister packs (1×6, 1×10) or Alu-Alu configurations
- Printed cartons with multilingual labeling
- Tamper-evident packaging with batch coding
Oral Suspension:
- HDPE bottles with child-safe caps
- Measuring cups/spoons
- Individual cartons with reconstitution instructions and patient inserts
Serialization, QR coding, and country-specific labeling are available for regulated markets.
Quality Assurance and Testing
At BluepillExpress, we ensure multi-layered quality control for every product:
- Assay and content uniformity
- Dissolution and disintegration time
- Microbial and endotoxin limits
- Stability testing (accelerated & real-time)
- Heavy metal and residual solvent analysis
- Container-closure integrity
Each batch is certified with a Certificate of Analysis (COA), and complete traceability is maintained.
Regulatory Documentation Support
We offer full documentation to assist with product registration, regulatory filings, and global tender participation.
Documentation Includes:
- Certificate of Pharmaceutical Product (COPP)
- GMP and ISO Certificates
- Product Dossier (CTD Format)
- Certificate of Analysis (COA)
- Stability Data
- Method of Analysis (MOA)
- Free Sale Certificate, MSDS
- Batch Manufacturing Record (BMR)
We support clients across regulated (e.g., UAE, Philippines, Kenya) and semi-regulated markets.
Export Markets and Logistics
BluepillExpress is a trusted global exporter, delivering pharmaceuticals to over 30 countries with full logistics support.
Active Export Markets:
- Africa: Kenya, Nigeria, Ghana, Ethiopia, Tanzania
- Asia-Pacific: Vietnam, Philippines, Sri Lanka, Bangladesh
- Middle East: Iraq, UAE, Oman, Jordan
- CIS Nations: Kazakhstan, Uzbekistan, Armenia
- Latin America: Bolivia, Dominican Republic, Peru
We handle all international shipment documentation, including invoice, packing list, COA, airway bill, and customs clearance assistance.
Ideal Clients for Amoxicillin-Clavulanate
Our services cater to a wide spectrum of customers:
- Generic pharmaceutical brands
- Private label antibiotic sellers
- Hospitals and clinics
- Distributors and wholesalers
- Government and NGO procurement programs
- Tender-based buyers and institutions
Whether you’re building your own brand or supplying public health programs, BluepillExpress is your go-to partner.
Why Partner with BluepillExpress?
- WHO-GMP, ISO, and FSSAI certified manufacturing infrastructure
- Experienced R&D and formulation experts
- Flexible manufacturing schedules and scalable volumes
- Low MOQ with high-margin potential
- Regulatory and documentation support for international approvals
- White label and private label services with complete confidentiality
- Customer-centric service and on-time deliveries