Setastine API Manufacturer & Supplier in India

Setastine is a second-generation antihistamine with potent H1-receptor antagonist activity used for the symptomatic relief of allergic conditions. It demonstrates low CNS penetration, resulting in minimal sedation compared to classical antihistamines. Setastine is effective in managing urticaria, allergic rhinitis, and other IgE-mediated hypersensitivity reactions. Mediocon Inc manufactures GMP-certified Setastine API at its Aurangabad facility.

• Allergic rhinitis
• Urticaria and skin allergies
• IgE-mediated hypersensitivity
• Non-sedating antihistamine formulations

• GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
• Full pharmacopoeial compliance: IP / BP / EP / USP standards
• Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
• Stringent in-process quality control at every manufacturing stage
• HPLC purity testing and spectroscopic identification (IR, NMR)
• Cold-chain and controlled-environment storage facilities available
• Exported to 40+ countries with full regulatory support

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Setastine — CAS 116476-13-2 (CAS 116476-13-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Setastine — CAS 116476-13-2 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, 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/X compliance; all state licensing documentation provided

Quality & Compliance

• ISO 9001:2015 certified quality management system
• GMP-certified manufacturing facility, Aurangabad, Maharashtra
• Full batch traceability from raw material to finished API
• Stability data available (ICH Q1A guidelines) for regulatory submissions
• Dedicated QA team for customer audits and regulatory queries