Pemirolast Potassium API Manufacturer & Supplier in India

Pemirolast Potassium is the potassium salt form of Pemirolast, widely used as an ophthalmic antiallergic agent. Mediocon Inc manufactures this GMP-certified API at its Aurangabad, Maharashtra facility. The compound acts by preventing mast cell degranulation and blocking histamine release, providing effective relief in allergic eye diseases. It is formulated primarily as ophthalmic drops for allergic conjunctivitis.

• Ophthalmic antiallergic therapy for allergic conjunctivitis
• Prevention of itching associated with allergic conjunctivitis
• Mast cell stabilization in ocular mucosa
• Seasonal and perennial ocular allergic conditions

• 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 Pemirolast Potassium — CAS 100299-08-9 (CAS 100299-08-9) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Pemirolast Potassium — CAS 100299-08-9 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