Erythromycin Stearate

Erythromycin Stearate is a macrolide antibiotic used for the treatment of a wide range of bacterial infections. It is an esterified derivative of erythromycin, formulated to improve acid stability and gastrointestinal tolerance when administered orally. Erythromycin Stearate is primarily used to combat infections caused by susceptible strains of Gram-positive and some Gram-negative organisms, including respiratory tract infections, skin and soft tissue infections, and sexually transmitted infections.

At BluepillExpress, we specialize in third-party manufacturing of Erythromycin Stearate tablets and suspensions, tailored to meet international pharmacopeial standards and export-grade quality requirements. We offer complete end-to-end support, from formulation development and regulatory compliance to private label packaging and global logistics.

About BluepillExpress

BluepillExpress is a WHO-GMP and ISO 9001:2015 certified pharmaceutical manufacturing and export company, dedicated to providing high-quality, affordable, and compliant medications to global healthcare markets. With over a decade of industry experience and a growing client base in more than 50 countries, we manufacture a wide range of finished dosage forms, including antibiotics, antivirals, analgesics, and nutraceuticals.

We offer full-spectrum third-party and contract manufacturing services for domestic and international pharmaceutical companies, public health programs, government tenders, and private label clients. Our operations are driven by a commitment to quality, safety, efficacy, and client confidentiality.

Pharmacological Classification

• Drug Class: Macrolide Antibiotic
• Therapeutic Use: Antibacterial treatment for respiratory, skin, ear, and soft tissue infections
• Dosage Forms Available: Tablets, Oral Suspension (Dry Syrup)
• Route of Administration: Oral

Mechanism of Action

Erythromycin Stearate, a derivative of erythromycin, works by inhibiting bacterial protein synthesis. It binds to the 50S ribosomal subunit of susceptible microorganisms, preventing translocation of peptides during translation, thereby halting bacterial growth.

It exhibits bacteriostatic activity, though it may be bactericidal at higher concentrations or against highly susceptible organisms.

Clinical Indications

Erythromycin Stearate is indicated for the treatment of infections caused by erythromycin-sensitive organisms, such as:

• Upper and lower respiratory tract infections (e.g., pharyngitis, bronchitis, pneumonia)
• Skin and soft tissue infections
• Otitis media
• Sinusitis
• Diphtheria
• Pertussis (whooping cough)
• Erythrasma
• Syphilis (in penicillin-allergic patients)
• Campylobacter enteritis
• Acne vulgaris (long-term use)

It is particularly useful in penicillin-allergic patients and in treating atypical pathogens such as Mycoplasma pneumoniae, Chlamydia trachomatis, and Legionella pneumophila.

Dosage Forms Available for Manufacturing at BluepillExpress

We offer customizable third-party manufacturing of Erythromycin Stearate in the following dosage forms and strengths:

1. Oral Tablets

• Erythromycin Stearate 250 mg Tablets
• Erythromycin Stearate 500 mg Tablets
• Coated for improved taste and gastrointestinal protection
• Available in blister or strip packaging

2. Oral Suspension (Dry Syrup)

• Erythromycin Stearate 125 mg/5 mL
• Erythromycin Stearate 250 mg/5 mL
• Sugar-based and sugar-free formulations
• Pediatric-friendly flavors (e.g., strawberry, orange, banana)
• Reconstitution instructions provided on labeling

We also provide custom strengths and flavor profiles based on specific market and client requirements.

Manufacturing Infrastructure and Capabilities

BluepillExpress operates in state-of-the-art pharmaceutical manufacturing units, certified by leading regulatory bodies. Our infrastructure includes:

• Dedicated facilities for oral solids and liquid preparations
• Separate AHUs (air-handling units) for each manufacturing area
• Automated tablet compression, coating, and packaging lines
• Dry syrup processing lines with accurate dosing and sealing systems
• Integrated laboratory services for raw material and finished product testing

We maintain batch-wise traceability, strict quality control, and full documentation at every step of production.

Quality Assurance and Regulatory Compliance

Our Quality Assurance (QA) and Quality Control (QC) teams work closely to ensure that every batch meets global safety, efficacy, and regulatory expectations. Key quality operations include:

• Raw material verification using pharmacopeial standards (IP, BP, USP)
• In-process controls to monitor uniformity, weight, hardness, and disintegration
• Microbial testing for oral suspensions
• Finished product assay and dissolution testing
• Real-time and accelerated stability studies

All products are manufactured under cGMP and Schedule M conditions and are supported with:

• Certificate of Analysis (COA)
• Batch Manufacturing Records (BMR)
• Validation protocols
• Stability data (available on request)

Packaging & Labeling Options

BluepillExpress offers a wide range of custom packaging solutions that comply with international standards and branding preferences.

Tablet Packaging:

• PVC/Alu blister packs or Alu/Alu packs
• 10×10 strip format or bulk bottle packs
• Printed cartons with product information leaflets

Oral Suspension Packaging:

• Amber PET or glass bottles (60 mL, 100 mL, 150 mL)
• Child-proof caps and measuring spoons or cups
• Flavor-masked formulations for pediatric use

We support multilingual label design, custom branding, and private labeling for all markets, including USA, EU, GCC, ASEAN, and Africa.

Regulatory and Export Documentation Support

As a global exporter of pharmaceutical formulations, BluepillExpress provides full documentation support to ensure seamless market registration and product importation. We provide:

• WHO-GMP Certificate
• Certificate of Pharmaceutical Product (COPP)
• Certificate of Origin
• Free Sale Certificate
• Certificate of Analysis (COA)
• Master Formula Records
• Product Dossiers (CTD/ACTD format)
• MSDS (Material Safety Data Sheets)

We have extensive experience in registering products with regulatory bodies in:

• Africa (Nigeria, Kenya, Ghana, Ethiopia, Tanzania)
• Southeast Asia (Vietnam, Philippines, Myanmar)
• CIS (Uzbekistan, Kazakhstan)
• Latin America
• Middle East and GCC countries

Private Label and Third-Party Manufacturing Services

We offer end-to-end private label services to help you build or expand your brand with high-quality Erythromycin Stearate formulations. Services include:

• Custom formulation based on market-specific guidelines
• Branding and label design services
• Regulatory document preparation and submission support
• Packaging development (print-ready carton and label design)
• Competitive pricing and flexible MOQs
• Logistics coordination and global shipping support

Our confidentiality agreements and IP protection policies ensure complete brand security.

Target Client Segments

Our Erythromycin Stearate third-party manufacturing services cater to:

• Generic pharmaceutical companies
• Hospital procurement agencies
• Retail pharmacy chains
• Distributors and importers
• Government and NGO tenders
• Telemedicine and e-pharmacy platforms
• Pediatric and infectious disease product portfolios

Sustainability and Ethical Practices

At BluepillExpress, we uphold our responsibility toward sustainable pharmaceutical manufacturing through:

• Environmentally friendly waste management systems
• Efficient use of resources (energy, water, raw materials)
• Eco-conscious packaging materials (recyclable where possible)
• Ethical sourcing of raw materials
• Zero child labor policy and fair wages

Our commitment to sustainability aligns with international best practices for health and environmental safety.

Steps to Start Manufacturing with BluepillExpress

1. Initial Consultation
   Share your requirement for Erythromycin Stearate (dosage form, strength, market destination, quantity).
2. Quotation & Agreement
   We provide transparent pricing, delivery timelines, and regulatory requirements for review and confirmation.
3. Product Development
   Our technical and regulatory teams create pilot batches or submit pre-shipment samples as needed.
4. Manufacturing & Quality Testing
   Production begins under WHO-GMP conditions. All products are tested for quality, potency, and safety.
5. Labeling & Packaging
   We package and label the products as per your branding and country-specific compliance.
6. Dispatch & Documentation
   Products are dispatched with full regulatory documentation and support for import clearance.

Conclusion

Erythromycin Stearate remains a cornerstone in the treatment of bacterial infections, especially in patients allergic to penicillin and in managing atypical pathogens. Its excellent safety profile, broad therapeutic use, and global demand make it an essential product in any antibiotic portfolio.

BluepillExpress offers customized, compliant, and cost-effective third-party manufacturing solutions for Erythromycin Stearate. With certified facilities, expert teams, and export-ready documentation, we enable pharmaceutical businesses worldwide to offer trusted, high-quality antibiotics under their own brand name.