BioGalen Pharmaceuticals

Azithromycin Tablets

Antibiotics · Film-Coated Tablets · 250mg / 500mg / 1gm

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Trade Information

Minimum Order Qty 10,000 tablets
Capacity 100 Million Tablets per month
Strength 250mg / 500mg / 1gm
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
Azithromycin Tablets 250mg / 500mg / 1gm - BioGalen Pharmaceuticals

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, CIS, and Latin American 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 Azithromycin Dihydrate
Dosage Form Film-Coated Tablets
Pack Size 1x3, 1x6, 10x3, 10x6 / Custom packing available
Storage Store below 30°C in a dry place, protected from light and moisture
Shelf Life 24 months from date of manufacture

Description

Azithromycin is a broad-spectrum macrolide antibiotic used to treat a wide range of bacterial infections. It is one of the most commonly prescribed antibiotics worldwide and is listed on the WHO Model List of Essential Medicines.

Azithromycin is highly valued for its convenient short-course dosing (typically 3-day regimen), excellent tissue penetration, and broad antibacterial spectrum covering both gram-positive and gram-negative organisms as well as atypical pathogens.

BioGalen manufactures Azithromycin Tablets in 250mg, 500mg, and 1gm strengths. Our products are widely exported to Africa, Southeast Asia, Latin America, and CIS countries for both government tender procurement and private sector distribution.

Mechanism of Action

Azithromycin is a 15-membered ring macrolide (azalide) antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, specifically at the 23S rRNA component of the ribosome. This blocks the translocation step of protein synthesis, preventing the growing peptide chain from moving to the next codon position, effectively halting bacterial growth. Azithromycin is bacteriostatic at standard concentrations but can be bactericidal at higher tissue concentrations against susceptible organisms. Its key pharmacological advantage is extensive tissue accumulation — Azithromycin concentrates inside phagocytes and is transported directly to sites of infection, achieving tissue concentrations 10–100 times higher than plasma levels. This tissue accumulation, combined with a tissue half-life of 2–4 days, allows the unique 3-day treatment course (versus 7–14 days for most other antibiotics), significantly improving patient compliance.

Indications

  • Upper and lower respiratory tract infections (pneumonia, bronchitis)
  • Ear, nose, and throat infections (otitis media, sinusitis, pharyngitis, tonsillitis)
  • Skin and soft tissue infections
  • Sexually transmitted infections (chlamydia, gonorrhoea)
  • Typhoid and enteric fever
  • Traveller's diarrhoea
  • Urethritis and cervicitis
  • Prevention of Mycobacterium avium complex (MAC) in HIV patients

Available Variants

  • Azithromycin Tablets 250mg
  • Azithromycin Tablets 500mg
  • Azithromycin Tablets 1gm
  • Azithromycin Suspension
  • Azithromycin 500mg Injection

Frequently Asked Questions

Why is the 3-day dosing regimen a commercial advantage for Azithromycin?
Azithromycin's 3-day course (one tablet daily for 3 days) is one of the shortest antibiotic regimens available. This is a major advantage in markets where patient compliance is a challenge — particularly in outpatient settings across Africa and Asia. For B2B buyers, the short course means smaller pack sizes (1x3 blisters), lower per-treatment cost for patients, and strong demand from prescribers who value compliance.
What strengths are most in demand across export markets?
The 500mg strength is the highest-volume SKU, used for the standard adult 3-day course (500mg once daily x 3 days). The 250mg is used for step-down dosing and paediatric prescriptions. The 1gm single-dose tablet is specifically used for single-dose treatment of sexually transmitted infections (chlamydia, gonorrhoea). Most distributors stock 500mg as their primary SKU with 250mg as a secondary line.
How does Azithromycin compare to Amoxicillin for antibiotic procurement?
Amoxicillin is a first-line, high-volume penicillin for basic infections. Azithromycin covers atypical pathogens (Mycoplasma, Chlamydia, Legionella) that Amoxicillin cannot, and is a first-line choice for community-acquired pneumonia in many guidelines. Azithromycin is a higher-value product with better margins. Most distributors carry both as they serve different clinical needs and together cover the majority of outpatient antibiotic prescribing.
Is Azithromycin used in any public health programmes beyond standard antibiotic use?
Yes. Azithromycin is used in mass drug administration (MDA) programmes for trachoma elimination (the SAFE strategy recommended by WHO) and has been studied for child mortality reduction in Sub-Saharan Africa. These programme-level procurements represent significant additional demand beyond routine clinical use and typically require WHO-GMP certification and CTD dossiers — both of which BioGalen provides.

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