Azithromycin

Azithromycin is a widely prescribed, broad-spectrum macrolide antibiotic known for its effectiveness, tolerability, and convenient dosing schedule. Structurally derived from erythromycin, Azithromycin exhibits an expanded antimicrobial spectrum and improved pharmacokinetic properties. It is particularly useful in the treatment of bacterial infections involving the respiratory tract, skin, soft tissues, ear, and genitourinary system, including sexually transmitted infections (STIs).

As antibiotic resistance becomes a growing global concern, the demand for quality-assured, compliant, and therapeutically effective formulations of Azithromycin continues to rise. BluepillExpress offers comprehensive third-party manufacturing services for Azithromycin in a variety of dosage forms and strengths, backed by WHO-GMP facilities, international certifications, and robust regulatory compliance.

We work with pharmaceutical companies, healthcare brands, government tender participants, and global distributors to deliver safe, effective, and customizable Azithromycin formulations that meet international pharmacopoeial standards.

Therapeutic Applications

Azithromycin is indicated for the treatment of infections caused by susceptible strains of bacteria in the following conditions:

• Upper Respiratory Tract Infections: Pharyngitis, sinusitis, tonsillitis
• Lower Respiratory Tract Infections: Acute bronchitis, community-acquired pneumonia
• Ear Infections: Otitis media
• Skin and Soft Tissue Infections
• Sexually Transmitted Infections (STIs): Including chlamydia and gonorrhea
• Genitourinary Infections: Non-gonococcal urethritis, cervicitis
• Traveler’s Diarrhea: Due to bacterial pathogens
• Mycobacterial Infections: In combination therapy for Mycobacterium avium complex (MAC)

Its once-daily dosing and short treatment duration have made Azithromycin a preferred antibiotic in outpatient care settings globally.

Mechanism of Action

Azithromycin works by inhibiting bacterial protein synthesis. It binds to the 50S ribosomal subunit of susceptible microorganisms, thereby blocking the translocation steps of protein synthesis. This results in the inhibition of bacterial growth, making it bacteriostatic at low concentrations and bactericidal at higher concentrations or against highly susceptible organisms.

Its unique tissue distribution properties allow Azithromycin to achieve high intracellular concentrations, contributing to prolonged half-life and extended post-antibiotic effects, which supports short-course therapy regimens.

Dosage Forms Offered by BluepillExpress

BluepillExpress provides Azithromycin in a wide range of dosage forms tailored to specific therapeutic applications and market demands. Available formulations include:

1. Azithromycin Tablets / Film-Coated Tablets

• 250 mg
• 500 mg
• 600 mg (often used for pediatric infections or combination regimens)

2. Azithromycin Oral Suspension / Dry Syrup

• 100 mg/5 ml
• 200 mg/5 ml
• 300 mg/5 ml
• Powder for reconstitution, flavored for pediatric compliance

3. Azithromycin Capsules

• 250 mg
• 500 mg

4. Azithromycin Injection (Powder for Solution)

• 500 mg/vial (for IV use in hospital settings)

All formulations are compliant with IP, BP, USP, and EP standards and are available for private labeling and export worldwide.

BluepillExpress Manufacturing Excellence

As a trusted third-party manufacturer and global exporter, BluepillExpress combines pharmaceutical expertise with world-class infrastructure to deliver consistently high-quality Azithromycin products. Our clients include both established pharmaceutical giants and emerging brands.

1. WHO-GMP and ISO-Certified Facilities

Our manufacturing units are certified by:

• WHO-GMP
• ISO 9001:2015
• ISO 22000
• FSSAI (India)
• USFDA Registered (for export markets)

Dedicated facilities for beta-lactam-free production and aseptic processing ensure cross-contamination-free manufacturing of macrolides such as Azithromycin.

2. Advanced Production Capabilities

We utilize:

• High-speed tablet presses and capsule fillers
• Fluid bed processors and granulators
• Automated dry syrup filling lines
• Sterile injectable processing areas
• Integrated track-and-trace systems for batch monitoring

All production adheres to cGMP standards under the supervision of qualified pharmacists, microbiologists, and process engineers.

Quality Control and Assurance

Our Quality Assurance and Quality Control (QA/QC) teams implement rigorous protocols for every stage of production. All Azithromycin formulations undergo:

• Active ingredient assay and identification
• Dissolution testing
• Microbial limit testing
• Related substances and impurity profiling
• Heavy metals testing
• Stability studies under ICH conditions

Each batch is released only after satisfying comprehensive analytical criteria to ensure safety, efficacy, and compliance.

Customization and Private Label Services

We understand that product differentiation is critical for market success. BluepillExpress offers customized Azithromycin manufacturing based on client requirements, including:

• Strength and formulation tailoring (single or combination antibiotics)
• Packaging style (blister packs, strip packs, bottles, cartons)
• Pediatric flavor options (e.g., orange, banana, strawberry)
• Branded or unbranded label printing
• Packaging in multilingual formats for export

Private label services are available for companies looking to launch or expand their antibiotic product line under their own brand name.

Regulatory Documentation and Export Readiness

Our team provides complete support for global registrations by preparing and submitting all necessary documentation:

• Certificate of Analysis (COA)
• Product Development Reports
• Certificate of Pharmaceutical Product (COPP)
• Dossiers in CTD/eCTD/ACTD formats
• Batch Manufacturing Records (BMR)
• Method of Analysis (MOA)
• Material Safety Data Sheets (MSDS)
• Bioequivalence (BE) support (on request)

Our documentation is acceptable for MOH submissions across Asia, Africa, CIS, Latin America, and the Middle East.

Global Export and Supply Chain Strength

BluepillExpress is an experienced pharmaceutical exporter, supplying Azithromycin to:

• Hospitals, clinics, and pharmacies
• Government tenders and public health programs
• NGOs and international aid organizations
• Retail chains and e-commerce distributors

We are currently exporting to:

• African countries (Nigeria, Kenya, Ghana, Ethiopia)
• Southeast Asia (Vietnam, Cambodia, Indonesia)
• Middle East (UAE, Saudi Arabia, Jordan)
• Latin America (Peru, Ecuador, Bolivia)
• CIS and Central Asia (Kazakhstan, Kyrgyzstan)

We offer flexible incoterms (EXW, FOB, CIF), temperature-controlled shipping, and multilingual packaging for customs clearance.

Research and Development Capabilities

Innovation is a core focus at BluepillExpress. Our R&D division supports:

• Development of Azithromycin combination therapies (e.g., Azithromycin + Cefixime)
• Formulation of extended-release Azithromycin tablets
• Pediatric-friendly dispersible formulations
• Novel flavor and color customization
• pH-stable and highly bioavailable suspensions

We also provide support in bioequivalence studies, dissolution profiling, and comparative analytical studies for regulatory approval.

Environmental and Safety Commitment

BluepillExpress upholds a strong commitment to safety, hygiene, and environmental sustainability:

• Zero-discharge effluent treatment plants (ETPs)
• Controlled environments for macrolide handling
• HEPA-filtered HVAC systems
• Employee health screening and training
• Compliance with local and international environmental guidelines

All manufacturing and packaging activities are aligned with Good Manufacturing Practices (GMP), ensuring product safety and worker protection.

Shelf Life and Storage Conditions

• Standard shelf life: 24 to 36 months
• Storage: Store in a cool, dry place below 25°C; protect from moisture and sunlight
• Pediatric reconstituted suspensions should be used within 5 to 7 days, depending on labeling

We offer stability-tested products suitable for export to Zone III and IV countries, where humidity and heat are significant concerns.

Conclusion

Azithromycin remains a powerful and versatile antibiotic in today’s global healthcare landscape. Its effectiveness across multiple bacterial infections, short-course therapy advantages, and strong patient compliance profile make it a staple in both community and hospital settings.

At BluepillExpress, we are proud to be a trusted third-party manufacturing partner for Azithromycin, delivering formulations that adhere to global quality standards while offering flexibility, compliance, and market adaptability.