Simfibrate API Manufacturer & Supplier in India

Simfibrate is a symmetric diester of clofibric acid used as a lipid-modifying agent primarily for reducing elevated triglyceride and cholesterol levels. It belongs to the fibrate class of antihyperlipidemic drugs and reduces hepatic VLDL production. Mediocon Inc manufactures GMP-compliant Simfibrate API from its Aurangabad manufacturing unit.

• Hyperlipidemia management
• Triglyceride reduction
• Lipid-lowering formulations
• Cardiovascular risk reduction

• 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 Simfibrate — CAS 14929-11-4 (CAS 14929-11-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Simfibrate — CAS 14929-11-4 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