Azithromycin

Azithromycin is a widely prescribed macrolide antibiotic used in the treatment of a broad range of bacterial infections affecting the respiratory tract, skin, ear, and sexually transmitted infections (STIs). Due to its convenient dosing regimen, high efficacy, and favorable safety profile, Azithromycin remains a cornerstone in modern antimicrobial therapy.

As the demand for broad-spectrum antibiotics continues to rise globally, BluepillExpress offers world-class third-party manufacturing services for Azithromycin tablets, capsules, and oral suspensions. Our state-of-the-art GMP-certified facilities are capable of producing high-quality, export-ready formulations that meet international pharmacopoeial standards.

About Azithromycin

Azithromycin is a semi-synthetic macrolide antibiotic derived from erythromycin. It acts by inhibiting bacterial protein synthesis, leading to the elimination of a wide array of pathogens, including atypical bacteria. It is particularly effective for respiratory infections and is commonly used for community-acquired infections.

Therapeutic Class: Macrolide Antibiotic
Mechanism of Action: Inhibits bacterial 50S ribosomal subunit, blocking protein synthesis
Route of Administration: Oral (tablets, capsules, suspension), intravenous (optional on request)
Dosing Regimen: Once-daily administration due to long half-life

Common Indications

Azithromycin is widely prescribed for:

• Upper and lower respiratory tract infections
• Bacterial sinusitis and pharyngitis
• Skin and soft tissue infections
• Otitis media (ear infections)
• Community-acquired pneumonia
• Urethritis and cervicitis (including Chlamydia trachomatis)
• Traveler’s diarrhea (in selected regions)
• Prophylaxis in HIV-infected patients (Mycobacterium avium complex)

Its favorable pharmacokinetics and simplified dosing contribute to better patient compliance and therapeutic outcomes.

Why Choose BluepillExpress for Azithromycin Manufacturing?

At BluepillExpress, we combine advanced pharmaceutical technologies with global quality standards to provide scalable third-party manufacturing solutions. Our commitment to compliance, efficiency, and partnership ensures your brand receives the highest quality products with competitive pricing and timely delivery.

Key Manufacturing Advantages:

• WHO-GMP, ISO 9001:2015, and FSSAI certified facilities
• British Pharmacopoeia (BP), USP, and IP compliant formulations
• Low minimum order quantities (MOQs) for startups and distributors
• International standard packaging and private label services
• Customizable strengths and flavor options for global markets
• Complete regulatory support for domestic and international clients

Product Range and Dosage Forms

We manufacture Azithromycin in various forms and strengths to cater to both pediatric and adult populations:

Tablets

• Azithromycin 250 mg Tablets
• Azithromycin 500 mg Tablets

Capsules

• Azithromycin 250 mg Capsules
• Azithromycin 500 mg Capsules

Oral Suspension (Dry Syrup)

• Azithromycin 100 mg/5 ml Suspension (Reconstitution volume: 15 ml, 30 ml)
• Azithromycin 200 mg/5 ml Suspension (Reconstitution volume: 15 ml, 30 ml)

Packaging:

• Tablets/Capsules: Alu-Alu or Blister Packs (1×3, 1×6, 1×10)
• Suspension: HDPE bottle with measuring cap/spoon and external carton

Customizations are available for brand labeling, language support, flavor (e.g., strawberry, orange, banana), and sugar-free formulations.

Composition and Ingredients

Our formulations are designed to ensure stability, optimal absorption, and patient compliance.

Azithromycin Tablet (500 mg)

• Active Ingredient: Azithromycin Dihydrate equivalent to Azithromycin 500 mg
• Excipients: Lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, magnesium stearate, and film-coating agents

Azithromycin Oral Suspension (200 mg/5 ml)

• Active Ingredient: Azithromycin Dihydrate equivalent to Azithromycin 200 mg per 5 ml
• Excipients: Sucrose, sodium benzoate, xanthan gum, flavoring agents, and stabilizers

Taste masking and enhanced dispersion technologies are used for pediatric formulations.

Manufacturing Process

Our manufacturing process is designed for consistency, quality, and efficiency, conforming to cGMP protocols and ICH guidelines.

1. API Sourcing: We use high-purity Azithromycin Dihydrate from validated and certified suppliers.
2. Granulation and Blending: Controlled wet or dry granulation ensures homogenous blend.
3. Compression and Coating: Tablets are compressed using rotary machines and film-coated to enhance stability and patient compliance.
4. Dry Syrup Filling: Dry syrup is filled using high-speed filling lines with automatic weight checks and moisture protection.
5. Quality Testing: Each batch undergoes in-process and final testing for assay, dissolution, uniformity, microbial limits, and pH.

All operations take place in cleanroom environments equipped with HEPA filters and controlled temperature and humidity.

Quality Assurance and Regulatory Compliance

We adhere to a strict quality management system at every stage of production:

• Stability Testing (Real-time & Accelerated)
• Microbial Testing & Endotoxin Limits
• Dissolution and Disintegration Testing
• Assay and Content Uniformity
• Residual Solvents and Moisture Analysis
• Batch Traceability and Documentation

Every shipment is accompanied by complete documentation:

• Certificate of Analysis (COA)
• Certificate of Pharmaceutical Product (COPP)
• Product Dossier (CTD format on request)
• Stability Data
• GMP and ISO Certificates
• Free Sale Certificate, MSDS, and Import Support Documents

We ensure compliance with the export regulations of WHO, US FDA, EMA, MHRA, SFDA, ANVISA, and other global authorities.

Packaging Options and Customization

We offer a wide array of customizable packaging solutions suitable for:

• Retail pharmacies
• Hospital tenders
• Government procurement programs
• Pediatric-specific packaging

Tablet & Capsule Packaging:

• Alu-Alu and PVC Blisters in printed cartons
• Bulk packs for institutional supply
• Multilingual labels and tamper-evident seals

Oral Suspension Packaging:

• Child-safe HDPE bottles with induction sealing
• Measuring cups, spoons, or droppers included
• Sugar-free and flavored variants available

All packaging is compliant with labeling laws, including barcode printing, batch numbers, expiry dates, and MRP requirements.

Export Capabilities

BluepillExpress is a trusted global exporter of antibiotics, supplying Azithromycin to:

• Africa: Kenya, Nigeria, Ghana, Ethiopia, Rwanda
• Asia-Pacific: Vietnam, Philippines, Sri Lanka, Bangladesh
• Middle East: Iraq, Saudi Arabia, UAE, Jordan
• CIS Nations: Kazakhstan, Uzbekistan, Armenia
• Latin America: Bolivia, Dominican Republic, Peru
• Island Markets: Papua New Guinea, Fiji, Maldives

Our team handles all international documentation, shipping logistics, and compliance for regulated, semi-regulated, and tender markets.

Market Segments We Serve

Our Azithromycin range is suitable for:

• Generic Pharma Companies
• Private Label Brands
• Hospital and Institutional Supply Chains
• National Health Programs and NGO Projects
• E-commerce and OTC Distribution

Whether you’re launching a new product or expanding into global markets, we offer full support to establish or scale your antibiotic product line.

Benefits of Azithromycin Formulations

• Broad-spectrum coverage against respiratory, urogenital, and skin pathogens
• Once-daily dosing improves patient adherence
• Short-course therapy (3 to 5 days) with prolonged tissue concentration
• Safe in pediatric and geriatric patients with proper dosage adjustments
• Available in palatable syrup forms for children

Azithromycin is included in the WHO Model List of Essential Medicines, further validating its global importance.

Why Partner with BluepillExpress?

Choosing BluepillExpress means partnering with a manufacturer dedicated to quality, transparency, and customer success. Here’s why brands and buyers across continents trust us:

• WHO-GMP and ISO-compliant production
• Global supply network and efficient logistics
• Competitive pricing with assured margins
• Low MOQs and flexible order terms
• Complete regulatory and documentation support
• Confidentiality, white-label services, and full traceability
• Rapid turnaround time and committed delivery schedules