Erythromycin Stearate API Manufacturer & Supplier in India

Erythromycin Stearate is the stearate salt form of Erythromycin, a macrolide antibiotic derived from Saccharopolyspora erythraea. It exerts its antibacterial activity by inhibiting bacterial protein synthesis through reversible binding to the 50S ribosomal subunit, thereby blocking the translocation step of peptide chain elongation. Mediocon Inc supplies pharmaceutical-grade Erythromycin Stearate conforming to IP / BP / EP / USP specifications.

The stearate salt form offers enhanced stability compared to Erythromycin Base, protecting the acid-labile macrolide from gastric degradation. It is absorbed in the upper small intestine and hydrolysed to free Erythromycin, delivering the same broad-spectrum antibacterial activity against Gram-positive organisms, atypical pathogens, and selected Gram-negative bacteria.

Key Features

• High-purity pharmaceutical grade API (Assay NLT 93.0%)
• IP / BP / EP / USP pharmacopoeial compliance
• Full CoA, MSDS/SDS, and COO documentation per batch
• GMP-certified manufacturing facility in Aurangabad, Maharashtra
• Stable stearate salt form — superior acid stability vs. base
• White to slightly yellow crystalline powder — consistent appearance

Therapeutic Applications

• Upper and lower respiratory tract infections (community-acquired pneumonia, bronchitis)
• Skin and soft tissue infections caused by susceptible organisms
• Sexually transmitted infections — chlamydia, syphilis (penicillin alternative)
• Diphtheria prophylaxis and treatment
• Legionnaire's disease and Mycoplasma pneumoniae infections
• Acne vulgaris (topical and systemic regimens)
• Pertussis (whooping cough) — prophylaxis and treatment

Industrial & Formulation Uses

• Film-coated tablet formulations — most common oral dosage form
• Reference standard for analytical and pharmacopoeia testing
• Veterinary antibiotic preparations
• Raw material for semi-synthetic macrolide derivatives

Why Choose Mediocon

• ISO 9001:2015 & WHO-GMP certified manufacturing
• Consistent batch-to-batch quality — HPLC-verified assay every lot
• Export-ready documentation: COO, MSDS, DMF support
• Flexible MOQ: 1 kg (R&D sample) to 500+ kg commercial lots
• Dedicated QA team for regulatory filings (US FDA, EMA, TGA)
• Competitive pricing with short lead times from Aurangabad facility

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Erythromycin Stearate (CAS 643-22-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Erythromycin Stearate is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP, BP, USP, EP). Every batch undergoes full analytical testing — identity (IR/HPLC), assay, related substances (Erythromycin A/B/C), residual solvents (ICH Q3C), heavy metals, and microbial limits — before release with a Certificate of Analysis.

Export Markets

• USA — FDA-registered facility; DMF support available for ANDA/NDA filings
• Europe — EMA-compliant documentation; CEP/EDMF support on request
• Africa & Middle East — WHO-GMP certified; competitive pricing for emerging markets
• Southeast Asia — established logistics network; temperature-controlled shipments
• India domestic — Schedule H compliance; all state licensing documentation provided

Quality & Compliance

• ISO 9001:2015 certified quality management system
• WHO-GMP certified manufacturing facility, Aurangabad, Maharashtra
• Full batch traceability — raw material to finished API
• Stability data available (ICH Q1A guidelines) for regulatory submissions
• Dedicated QA team for customer audits and regulatory queries
• Microbiological testing per USP <61> / <62> / BP 2.6.12