IndiaMart
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The continuous rise of bacterial infections and the evolving nature of microbial resistance require dependable, time-tested antibiotics. Among them, Erythromycin Stearate remains a widely used macrolide antibiotic, highly effective in the treatment of respiratory tract infections, skin diseases, and sexually transmitted infections. Recognized for its efficacy and patient tolerance, this oral erythromycin salt offers consistent therapeutic outcomes across age groups.
BluepillExpress, a global third-party pharmaceutical manufacturing leader, offers fully integrated contract manufacturing services for Erythromycin Stearate, ensuring unmatched quality, regulatory compliance, and global distribution capacity. With WHO-GMP certified production facilities, expert formulation scientists, and a reliable supply chain, we meet the demands of branded marketers, public health systems, hospitals, and global distributors seeking a reliable manufacturer for Erythromycin Stearate formulations.
What is Erythromycin Stearate?
Erythromycin Stearate is the stearate salt form of Erythromycin, a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit. It is particularly effective against Gram-positive cocci, some Gram-negative organisms, and atypical pathogens like Mycoplasma pneumoniae and Chlamydia trachomatis.
This salt form is preferred for oral administration due to its better gastrointestinal tolerance and improved palatability. Erythromycin Stearate is available in tablet and suspension forms and is indicated in:
- Upper and lower respiratory tract infections
- Skin and soft tissue infections
- Otitis media and sinusitis
- Pertussis (whooping cough)
- Diphtheria (as an alternative to penicillin)
- Prophylaxis of rheumatic fever in penicillin-allergic patients
- Certain STIs such as chlamydia and syphilis
Its broad spectrum and relatively mild side effect profile make it suitable for children, adults, and penicillin-sensitive patients.
Why Choose BluepillExpress for Erythromycin Stearate Manufacturing?
1. WHO-GMP & ISO Certified Infrastructure
BluepillExpress operates WHO-GMP, GMP, and ISO 9001:2015 certified pharmaceutical facilities. We are equipped to manufacture Erythromycin Stearate under tightly controlled conditions that ensure consistency, efficacy, and compliance with international pharmacopoeial standards.
2. Versatile Dosage Forms
We offer a range of oral dosage forms for Erythromycin Stearate to cater to diverse patient segments and regulatory requirements:
- Tablets:
- 250 mg
- 500 mg
- Oral Suspension (Dry Syrup):
- 125 mg/5 ml
- 250 mg/5 ml
- Customizable concentrations available upon request
All formulations are available in IP, BP, USP, and EP grades, with pediatric-friendly flavors and custom packaging configurations.
3. End-to-End Third-Party Manufacturing Support
From R&D and formulation development to regulatory dossier creation and finished product delivery, BluepillExpress offers a turnkey solution for pharmaceutical companies seeking to outsource manufacturing of Erythromycin Stearate.
We support:
- Brand customization (logo, artwork, packaging)
- Low MOQs and high-volume scale-up
- Global documentation and product registration
- Institutional, retail, and export packaging
Technical Product Specifications
| Product Name | Erythromycin Stearate |
|---|---|
| Strengths Available | 250 mg, 500 mg (Tablet); 125 mg/5 ml, 250 mg/5 ml (Suspension) |
| Dosage Forms | Tablets, Dry Syrup |
| Route of Administration | Oral |
| Pharmacopoeia Compliance | IP / BP / USP / EP |
| Packaging | Blister packs, strip packs, HDPE bottles, cartons |
| Shelf Life | 24 to 36 months depending on formulation |
| Storage Conditions | Store below 25°C; protect from light and moisture |
All products are manufactured using validated processes, and APIs sourced from approved GMP-compliant suppliers.
Indications and Therapeutic Uses
Erythromycin Stearate is prescribed for the treatment of a broad spectrum of infections, including:
Respiratory Tract Infections
- Pharyngitis, tonsillitis
- Pneumonia (community-acquired)
- Bronchitis
- Pertussis (whooping cough)
- Legionnaires’ disease
Skin and Soft Tissue Infections
- Impetigo
- Cellulitis
- Erysipelas
- Acne vulgaris (as adjunct therapy)
Ear and Throat Infections
- Otitis media
- Sinusitis
- Diphtheria (treatment and carrier state)
Sexually Transmitted Infections (STIs)
- Uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis
- Syphilis and gonorrhea (in penicillin-allergic patients)
Prophylactic Use
- Rheumatic fever prophylaxis
- Dental procedure-related infection prevention
Manufacturing Capabilities and Process Control
At BluepillExpress, Erythromycin Stearate is manufactured under strictly monitored conditions using a validated process. Our facilities are equipped with:
- High-speed tablet compression machines
- Advanced fluid bed dryers and granulators
- Rapid mixer granulators (RMG)
- Syrup filling, sealing, and labeling machines
- Controlled temperature and humidity environments
- Stability chambers for ICH-compliant testing
All manufacturing and packaging areas follow cleanroom classifications and cross-contamination control protocols, ensuring the integrity and purity of every batch.
Quality Assurance and Quality Control
Our QA/QC systems are built on cGMP principles and international standards. Each batch of Erythromycin Stearate undergoes:
- API identity, assay, and impurity profile verification
- In-process controls for blend uniformity, weight variation, and dissolution
- Finished product testing for microbial load, stability, and packaging integrity
- Leak testing, label adherence, and print clarity checks
- Post-production hold and release procedures
- Detailed documentation for traceability and compliance
Certificates of Analysis (CoA), Batch Manufacturing Records (BMR), and Method of Analysis (MOA) are provided with each consignment.
Packaging and Labeling
We offer customizable packaging solutions tailored to retail, hospital, and institutional settings. Options include:
For Tablets
- Alu-Alu and blister strips (10×10 or 1×10)
- Strip packs in printed cartons
- Mono cartons with bilingual or multilingual inserts
For Oral Suspension
- HDPE bottles (30 ml, 60 ml, 100 ml)
- Tamper-proof sealed caps
- Measuring cups or spoons included
- Attractive flavor-enhanced formulations for pediatric use
Packaging materials comply with global stability and transport regulations, ensuring long shelf life and patient safety.
Global Export and Regulatory Documentation
BluepillExpress is a trusted global exporter of antibiotics, offering full regulatory and documentation support for Erythromycin Stearate:
- Certificate of Pharmaceutical Product (CoPP)
- Certificate of Analysis (CoA)
- Free Sale Certificate
- Stability data (Zone II & IV)
- Product dossier (CTD/eCTD format)
- Manufacturing license and GMP certifications
- Import/export documentation and shipping compliance
We currently export to over 40 countries, including Africa, Southeast Asia, Middle East, Latin America, and CIS nations.
Client Segments We Serve
BluepillExpress offers third-party manufacturing of Erythromycin Stearate to a variety of clients:
- Generic pharmaceutical companies
- Pediatric and general medicine brands
- Government health departments and tender participants
- NGOs and international health organizations
- Exporters and distributors seeking ready-to-register products
- Private-label brands for global markets
Our team works closely with each partner to develop tailored solutions aligned with their marketing strategies, compliance needs, and product timelines.
Research & Development and Innovation
Our R&D team continuously strives to enhance formulation, palatability, and therapeutic performance. Services include:
- Taste-masking for pediatric formulations
- Bioequivalence study support (in collaboration)
- Packaging innovation for temperature-sensitive regions
- Fixed-dose combination development (on demand)
- Reformulation to meet country-specific regulatory needs
BluepillExpress also facilitates pilot batch production, validation studies, and technical dossier preparation for registrations in regulated and semi-regulated markets.
Sustainability and Ethical Manufacturing
At BluepillExpress, sustainability and ethics are foundational to our operations. We ensure:
- Eco-friendly packaging and waste management
- Zero liquid discharge systems in effluent treatment
- Ethical sourcing of raw materials
- Strict adherence to labor laws and safety norms
- No animal testing or use of banned substances
Our manufacturing practices align with international guidelines on health, safety, and environment.
Client Support and Confidentiality
BluepillExpress provides comprehensive client support throughout the manufacturing lifecycle:
- Confidentiality agreements and project protection
- Transparent pricing with no hidden charges
- Regulatory support with expert documentation
- Timely updates on production and dispatch
- Audit support and virtual plant tours (on request)
Whether launching a new brand or scaling production for export, our goal is to deliver trusted, seamless, and sustainable solutions.
Conclusion
Erythromycin Stearate continues to be a vital therapeutic option in combating bacterial infections, particularly in respiratory, dermatological, and sexually transmitted disease management. Its utility in pediatric and adult care, coupled with its excellent safety record, ensures steady demand worldwide.
BluepillExpress, with its commitment to pharmaceutical excellence, offers third-party manufacturing of Erythromycin Stearate that is consistent, compliant, and globally competitive. Our modern facilities, experienced teams, and robust supply chain make us the partner of choice for brands seeking growth, quality, and international presence.
