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In an age where antibiotic resistance is an ever-growing global concern, the need for broad-spectrum, beta-lactamase-resistant antibiotics has become paramount. Among the most trusted and widely used combinations in antimicrobial therapy is Amoxycillin and Potassium Clavulanate, a synergistic pairing of a penicillin-class antibiotic with a beta-lactamase inhibitor. This combination remains a first-line treatment for numerous community and hospital-acquired infections.
BluepillExpress, a trusted name in pharmaceutical third-party manufacturing, offers high-quality, WHO-GMP-certified production of Amoxycillin & Potassium Clavulanate formulations for domestic distribution and global export. Our manufacturing capabilities are fully equipped to handle both oral and parenteral dosage forms in varied strengths and formats to meet your brand’s specific market and regulatory demands.
What is Amoxycillin & Potassium Clavulanate?
Amoxycillin is a broad-spectrum, semi-synthetic penicillin antibiotic effective against many Gram-positive and Gram-negative organisms. Potassium Clavulanate, a beta-lactamase inhibitor, protects amoxycillin from enzymatic degradation by beta-lactamase-producing bacteria, thereby extending its antibacterial spectrum.
This synergistic formulation is particularly effective in treating infections caused by beta-lactamase-producing resistant strains, which would otherwise render amoxycillin ineffective when used alone.
Therapeutic Class
- Beta-lactam Antibiotic (Penicillin class)
- Beta-lactamase Inhibitor combination
- Broad-Spectrum Antibacterial
Key Benefits of Amoxycillin & Potassium Clavulanate
1. Broad Antibacterial Coverage
- Effective against both aerobic and anaerobic, Gram-positive and Gram-negative organisms
- Covers beta-lactamase-producing bacteria like E. coli, Klebsiella, Proteus, H. influenzae, and Staphylococcus aureus
2. Enhanced Efficacy
- Potassium clavulanate neutralizes beta-lactamase enzymes secreted by resistant bacteria
- Restores amoxycillin’s potency against resistant strains
- Reduces chances of treatment failure and recurrence
3. Versatile Clinical Application
- Suitable for respiratory tract infections, ENT infections, skin and soft tissue infections, UTIs, and dental infections
- Used in both pediatric and adult patients
4. Multiple Dosage Strengths and Forms
- Available in tablets, dry syrups, oral suspensions, and injections
- Facilitates precise dosing and patient compliance
5. Trusted Globally
- WHO-recommended combination
- Prescribed across primary and tertiary care centers
- Part of essential medicine lists in several countries
Indications
Amoxycillin & Potassium Clavulanate is indicated for the treatment of the following infections caused by susceptible strains:
- Upper respiratory tract infections (sinusitis, otitis media, pharyngitis, tonsillitis)
- Lower respiratory tract infections (bronchitis, pneumonia)
- Urinary tract infections (cystitis, pyelonephritis)
- Skin and soft tissue infections (cellulitis, impetigo, infected wounds)
- Bone and joint infections (osteomyelitis)
- Dental infections (abscesses, periodontitis)
- Gynecological infections
- Post-surgical infections
- Septicemia and bacteremia (IV form)
Composition and Strengths Offered
Oral Tablets (Film-Coated):
- 500 mg Amoxycillin + 125 mg Clavulanate
- 875 mg Amoxycillin + 125 mg Clavulanate
- 250 mg Amoxycillin + 125 mg Clavulanate (less common)
Oral Dry Syrup / Suspension:
- 200 mg Amoxycillin + 28.5 mg Clavulanate per 5 ml
- 400 mg Amoxycillin + 57 mg Clavulanate per 5 ml
- Bottle sizes: 30 ml, 60 ml, 100 ml (as per market requirement)
Injectables (IV):
- 1.2 gm (1000 mg Amoxycillin + 200 mg Clavulanate)
- 600 mg (500 mg Amoxycillin + 100 mg Clavulanate)
All strengths are manufactured with premium-quality Active Pharmaceutical Ingredients (APIs), compliant with USP/BP/EP standards and supported with validated analytical documentation.
Dosage and Administration
Dosage depends on infection severity, site of infection, patient age, renal function, and product formulation. General dosing includes:
- Adults (Tablets): 500/125 mg or 875/125 mg every 8–12 hours
- Children (Suspension): 20–40 mg/kg/day in divided doses
- IV Use (Hospitals): Administered every 8 hours via slow IV injection or infusion
Always to be used under the guidance of a registered medical practitioner.
Manufacturing Formats Available
BluepillExpress offers complete flexibility in manufacturing and packaging options, including:
Solid Oral Dosage Forms:
- Film-coated tablets
- Blister packs (10x1x10, 10×10)
- HDPE bottles (for institutional supply)
Liquid Oral Dosage Forms:
- Dry syrup with sterile water for reconstitution
- Flavored for pediatric use (strawberry, orange, mango)
- Supplied in amber bottles with measuring cups or droppers
Parenteral Forms:
- Sterile powder for injection in glass vials
- Supplied with sterile water ampoule (optional)
- Suitable for hospital and emergency care settings
Quality and Compliance
All Amoxycillin & Clavulanate formulations from BluepillExpress are produced in WHO-GMP, ISO 22000:2018, and FSSAI-certified manufacturing facilities under stringent quality assurance protocols.
Key Quality Parameters:
- Uniform API distribution in tablets and syrups
- Sterility, pyrogen, and endotoxin tests for injectables
- Dissolution, disintegration, and assay tests for oral forms
- Real-time and accelerated stability studies
- Microbiological, heavy metal, and impurity profiling
- Each batch is released only after complete internal QC approval
Regulatory and Export Documentation
We provide complete regulatory support for national and international product registration.
Documents Offered:
- Certificate of Analysis (CoA)
- Certificate of Pharmaceutical Product (COPP)
- Certificate of Origin (COO)
- Free Sale Certificate (FSC)
- Product Dossier (CTD/ACTD format on request)
- MSDS
- Manufacturing License Copy
- Stability Data
- Product Samples and Labeling Assistance
Export Services and Markets
BluepillExpress supplies Amoxycillin & Clavulanate formulations to a wide variety of clients including:
- Government tenders
- Pharmacy chains
- Institutional procurement agents
- Generic pharmaceutical distributors
- Private-label international clients
- Exporters to Southeast Asia, Africa, Latin America, and CIS countries
We ensure custom labeling, multilingual packaging, and region-specific compliance.
Shipping available under EXW, FOB, CIF, and DDP incoterms with both air and sea freight options.
MOQ and Lead Times
| Form | Minimum Order Quantity | Lead Time |
|---|---|---|
| Tablets (Blister Pack) | 100,000 strips | 20–25 working days |
| Dry Syrup | 25,000 bottles | 20–25 working days |
| Injections (Vials) | 50,000 units | 25–30 working days |
| Sample Development | 10–20 packs | 7–10 working days |
MOQ may vary slightly based on packaging materials, regulatory needs, and export country.
Target Market Opportunities
The Amoxycillin & Clavulanate market is expected to witness robust growth owing to:
- High incidence of bacterial infections in developing nations
- Global push for generics in antimicrobial therapy
- Inclusion in national essential medicines lists
- Wide spectrum utility in both outpatient and hospital care
- Rising resistance to older antibiotics
By offering this molecule through BluepillExpress, you get access to a well-established market, coupled with low manufacturing cost and high-volume scalability.
Why Partner with BluepillExpress?
- WHO-GMP certified production facilities
- Proven record of high-volume production
- Custom branding and white-label support
- Region-specific formulation and packaging
- Documentation ready for fast regulatory clearance
- Dedicated export team for end-to-end logistics coordination
- Competitive pricing for global competitiveness
Whether you are building your branded generic portfolio, supplying to public health sectors, or expanding to regulated or semi-regulated markets, BluepillExpress is your ideal contract manufacturing partner.
Conclusion
Amoxycillin & Potassium Clavulanate remains a cornerstone antibiotic therapy for a broad range of infections. With the growing need for quality, affordable, and globally compliant beta-lactam combinations, BluepillExpress is fully equipped to be your trusted third-party manufacturer for this vital product.
We combine regulatory expertise, state-of-the-art infrastructure, and flexible business models to help you bring your brand to local and international markets with confidence.
