Amoxicillin Capsules

Beta Lactams · Hard Gelatin Capsules · 250mg / 500mg

Trade Information

Minimum Order Qty	10,000 capsules
Capacity	100 Million Capsules per month
Strength	250mg / 500mg
Private Labelling	Custom branding, artwork & market-specific labelling
Lead Time	45–60 days from order confirmation
Payment Terms	LC at sight, TT (advance / against documents)
Shipping	FOB / CIF to major international ports including Mombasa, Dar es Salaam, Lagos, Durban, Manila, Phnom Penh
Pharmacopoeia	BP, USP, IP compliant

Packing Options

Blister (Alu-Alu / Alu-PVC)
Strip pack
Bottle pack (HDPE)
Hospital bulk pack
Custom packing as per buyer requirement

Regulatory & Quality

Registration Status	Registered in multiple African, Asian, and CIS markets. Dossier available for new market registration.
Regulatory Dossiers	CTD / ACTD format dossiers available for submission to national drug authorities.
Stability Data	Zone IVa & IVb stability data available (tropical climate conditions, 30°C/65% RH & 30°C/75% RH)
WHO Prequalification	WHO-GMP Certified

Product Details

Composition	Amoxicillin Trihydrate
Dosage Form	Hard Gelatin Capsules
Pack Size	10x10, Bottle of 100/500 / Custom packing available
Storage	Store below 25°C in a dry place, protected from light and moisture
Shelf Life	24 months from date of manufacture

Description

Amoxicillin is a broad-spectrum, semi-synthetic penicillin antibiotic used to treat a wide variety of bacterial infections. It is one of the most widely prescribed antibiotics worldwide and is listed on the WHO Model List of Essential Medicines.

BioGalen manufactures Amoxicillin Capsules in 250mg and 500mg strengths, suitable for both adult and paediatric prescriptions. Our capsules are formulated for optimal bioavailability and are manufactured under strict GMP conditions in our WHO-GMP certified facility.

Amoxicillin is a cornerstone antibiotic in primary healthcare across Africa, Asia, and Latin America, widely used in government health programmes and tender procurement.

Mechanism of Action

Amoxicillin is a beta-lactam antibiotic that works by inhibiting bacterial cell wall synthesis. It binds to penicillin-binding proteins (PBPs) located on the inner membrane of the bacterial cell wall, blocking the transpeptidation step in peptidoglycan synthesis. This weakens the cell wall, leading to osmotic instability and eventual bacterial cell lysis. Amoxicillin is bactericidal and effective against a broad range of Gram-positive and Gram-negative organisms, including Streptococcus pneumoniae, Haemophilus influenzae, Escherichia coli, and Helicobacter pylori.

Indications

Upper and lower respiratory tract infections
Urinary tract infections (UTIs)
Ear, nose, and throat infections (otitis media, sinusitis, tonsillitis)
Skin and soft tissue infections
Dental infections and abscesses
Helicobacter pylori eradication (in combination therapy)
Gonorrhoea (single-dose treatment)
Typhoid fever

Available Variants

Amoxicillin Capsules 250mg
Amoxicillin Capsules 500mg
Amoxicillin and Potassium Clavulanate Tablets 250mg + 125mg
Amoxicillin and Potassium Clavulanate Tablets 500mg + 125mg
Amoxicillin and Potassium Clavulanate and Lactic Acid Bacillus Oral Suspension
Amoxicillin Injection 1gm

Frequently Asked Questions

What is the difference between Amoxicillin and Amoxicillin-Clavulanate?

Amoxicillin alone is effective against non-resistant bacteria. Amoxicillin-Clavulanate (Co-Amoxiclav) adds Potassium Clavulanate, a beta-lactamase inhibitor that protects Amoxicillin from degradation by resistant bacteria. Co-Amoxiclav is preferred when beta-lactamase-producing organisms are suspected, such as in recurrent infections or hospital-acquired infections.

Can Amoxicillin Capsules be used in paediatric patients?

Amoxicillin Capsules 250mg can be prescribed for older children who can swallow capsules. For younger children, Amoxicillin Oral Suspension is the preferred dosage form as it allows weight-based dosing and easier administration. BioGalen manufactures both formulations.

What regulatory dossiers are available for Amoxicillin Capsules?

BioGalen provides CTD and ACTD format dossiers for Amoxicillin Capsules, including complete Module 3 (Quality), bioequivalence study data, stability studies (Zone IVa & IVb), and all supporting documentation required for national drug authority registration.

Is Amoxicillin Capsules available for private labelling?

Yes. BioGalen offers full private labelling services including custom branding, artwork design, market-specific packaging, and regulatory support for your brand registration. Minimum order quantities apply.

Interested in Amoxicillin Capsules?

Get competitive pricing for bulk orders, private labelling, and contract manufacturing.

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