Clarithromycin

Antibiotic therapy remains a critical component of modern healthcare, particularly in managing upper and lower respiratory tract infections, skin infections, and Helicobacter pylori-associated gastric conditions. Among the most effective and widely prescribed macrolides is Clarithromycin, known for its broad-spectrum antibacterial action, high oral bioavailability, and unique ability to penetrate tissues and bodily fluids efficiently.

At BluepillExpress, we offer Clarithromycin as part of our certified third-party manufacturing services, ensuring top-tier quality, precision, and consistency. Our state-of-the-art infrastructure supports the production of Clarithromycin tablets, dry syrups, and modified-release formulations for local brands, hospital supply, tenders, and global exports. We customize solutions tailored to meet the regulatory, market, and therapeutic needs of our partners worldwide.

What is Clarithromycin?

Clarithromycin is a semi-synthetic macrolide antibiotic, structurally related to erythromycin, that exhibits potent activity against a wide range of Gram-positive and Gram-negative bacteria, as well as certain atypical pathogens. It inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, thus preventing bacterial growth.

Clarithromycin is especially known for its efficacy in treating community-acquired pneumonia, pharyngitis, sinusitis, skin infections, and infections caused by Mycobacterium avium complex (MAC). Its dual routes of administration (oral and intravenous), tissue penetration, and acid-stable properties make it ideal for both outpatient and inpatient use.

Therapeutic Class

• Macrolide Antibiotic
• Antibacterial (broad-spectrum)
• Bacteriostatic at low doses; bactericidal at high doses

Key Benefits of Clarithromycin

1. Broad-Spectrum Antibacterial Action

Clarithromycin is effective against a wide variety of pathogens including:

• Streptococcus pneumoniae
• Haemophilus influenzae
• Moraxella catarrhalis
• Mycoplasma pneumoniae
• Chlamydia pneumoniae
• Helicobacter pylori
• Mycobacterium avium complex (MAC)

2. High Tissue Penetration

It achieves high concentrations in respiratory tissues, tonsils, sinuses, and skin, making it effective for both acute and chronic infections.

3. Dual Use in Respiratory and Gastrointestinal Infections

Clarithromycin is a component of combination therapy for H. pylori eradication, contributing to ulcer treatment and gastric health alongside its antimicrobial activity.

4. Favorable Dosing Regimen

It requires twice-daily dosing in most infections and has a sustained-release version for once-daily administration, which enhances patient compliance.

5. Well-Tolerated

Generally well tolerated with a lower incidence of gastrointestinal upset compared to older macrolides, making it suitable for pediatric and adult populations.

Indications

Clarithromycin is indicated for the treatment of mild to moderate infections caused by susceptible bacteria in the following conditions:

• Upper and lower respiratory tract infections (e.g., pharyngitis, tonsillitis, bronchitis, pneumonia)
• Skin and soft tissue infections (e.g., impetigo, folliculitis, cellulitis)
• Acute bacterial sinusitis
• Otitis media
• Helicobacter pylori eradication (used in combination with PPIs and other antibiotics)
• Mycobacterial infections, including Mycobacterium avium complex
• Community-acquired pneumonia
• Legionnaires’ disease

Clarithromycin is available in multiple dosage forms to serve pediatric, adult, and geriatric patients, including those with comorbidities.

Dosage Forms and Strengths Offered

BluepillExpress manufactures Clarithromycin in the following dosage strengths and forms, adhering to USP/BP/EP standards:

Tablets (Immediate or Extended-Release)

• Clarithromycin 250 mg
• Clarithromycin 500 mg
• Clarithromycin 500 mg Extended-Release

Oral Suspension / Dry Syrup

• Clarithromycin 125 mg/5 ml
• Clarithromycin 250 mg/5 ml
• Pack sizes: 30 ml, 60 ml, 100 ml bottles
• Pediatric-friendly flavors (strawberry, banana, orange)

Injectable (available on request)

• Clarithromycin for IV use (under development or partner facility arrangement)

Each formulation is manufactured using validated processes and passes all pharmacopeial requirements, including dissolution, assay, stability, and microbial limits.

Dosage and Administration

Dosage varies based on age, infection type, and patient profile. Common dosage guidelines:

• Adults: 250–500 mg twice daily for 7–14 days
• Extended-release tablets: 500 mg once daily for 7 days
• Pediatrics: 7.5 mg/kg body weight twice daily (maximum 500 mg per dose)
• H. pylori therapy (triple therapy): 500 mg twice daily + other agents

All doses should be administered under the supervision of a qualified healthcare provider.

Manufacturing Capabilities

BluepillExpress possesses modern manufacturing facilities with capacity to produce high-volume antibiotic formulations for various customer segments:

• Tablets: Over 1 million tablets/day
• Dry syrup filling: 100,000+ bottles/day
• Granulation and compression with online quality control
• Automatic blister packing, HDPE bottling, and customized carton packing
• Compliant with Good Manufacturing Practices (GMP) and Cleanroom Standards

Production is carried out in dedicated zones for beta-lactam-free products, ensuring cross-contamination control and batch integrity.

Packaging and Labeling

We offer multiple primary and secondary packaging options tailored to customer and regulatory requirements:

Primary Packaging:

• Tablets: Alu-Alu or PVC blister strips
• Dry Syrup: Amber PET or glass bottles with screw caps, sterile water, and dosage cups
• Customizable moisture-proof sachets (upon request)

Secondary Packaging:

• Multilingual mono cartons
• QR-coded and serialized labeling
• Government tender packs, pharmacy units, and hospital-grade kits
• Private-label and OEM branding support

All packaging materials are pharma-grade and compliant with international standards for labeling, product stability, and traceability.

Quality Assurance and Certifications

Our manufacturing facility is WHO-GMP certified, and adheres to the highest international quality systems.

Certifications:

• WHO-GMP
• ISO 22000:2018
• FSSAI Registered
• FDA India Manufacturing License
• Support for EU GMP / Gulf / African country registrations

Quality Control Protocols:

• API and excipient identification and validation
• In-process checks for blend uniformity and tablet hardness
• Final product testing for potency, dissolution, stability
• Microbial limit testing (TAMC, TYMC)
• Real-time and accelerated stability testing

Each batch is accompanied by a Certificate of Analysis (CoA) and retains full traceability and recall protocols.

Regulatory Support and Export Readiness

BluepillExpress provides a comprehensive suite of regulatory documents for local and international marketing, including:

• Certificate of Analysis (CoA)
• Certificate of Pharmaceutical Product (COPP)
• Certificate of Origin (COO)
• Free Sale Certificate (FSC)
• Product Dossier (CTD/ACTD formats)
• Stability Data
• Manufacturing and Marketing Authorizations
• Material Safety Data Sheet (MSDS)
• Product Artwork and Label Files

Our export team assists with registration filings, document legalization, and country-specific packaging needs.

Shipping and Export Services

We cater to both small and bulk volume shipments under EXW, FOB, CIF, or DDP incoterms. Services include:

• Freight forwarding (air or sea)
• Export documentation and customs support
• Cold chain packaging for temperature-sensitive formats
• Branded and unbranded delivery models
• Global service coverage including Africa, Southeast Asia, CIS, and Latin America

MOQ and Lead Times

Form	Minimum Order Quantity	Lead Time
Tablets	100,000 units	20–25 working days
Dry Syrup	25,000 bottles	20–30 working days
Extended-Release Tabs	50,000 units	25–30 working days
Sample Prototypes	20–30 packs	7–10 working days

Customized packaging or country-specific requirements may affect lead time.

Market Opportunity and Demand

The global market for macrolide antibiotics is growing due to:

• Rising cases of community-acquired pneumonia and respiratory infections
• Inclusion of Clarithromycin in triple therapy for H. pylori
• Demand for pediatric-friendly antibiotics with high safety margins
• Increase in outpatient care and telemedicine prescriptions
• WHO inclusion as an essential medicine in multiple countries

Clarithromycin’s ability to serve as both monotherapy and in combination regimens positions it as a staple antibiotic for prescribers globally.

Ideal Partners

Our third-party manufacturing services are suitable for:

• Pharmaceutical companies building branded generic portfolios
• Hospitals and institutional procurement agencies
• Government tender suppliers
• OTC medicine brands and private-label sellers
• International exporters in regulated/semi-regulated markets
• Telemedicine and e-pharmacy brands

Whether you are entering the antibiotic market or expanding your product range, Clarithromycin by BluepillExpress is a trusted, scalable, and regulatory-ready solution.

Why Partner with BluepillExpress?

• WHO-GMP compliant manufacturing for global markets
• Competitive pricing with flexible batch volumes
• End-to-end branding, formulation, and logistics support
• Fully documented product with CTD dossiers for rapid registration
• Responsive team with experience across 30+ export countries
• Focus on quality, integrity, and long-term partnerships

Conclusion

Clarithromycin is a high-impact macrolide antibiotic that offers broad-spectrum coverage, excellent tissue penetration, and a strong clinical safety profile. Whether for respiratory conditions, skin infections, or H. pylori treatment, it remains a reliable and preferred choice across global markets.

With BluepillExpress as your manufacturing partner, you gain access to premium-quality formulations backed by regulatory excellence, consistent supply, and full technical support.