Phenytoin API Manufacturer & Supplier in India

Phenytoin is a widely used antiepileptic drug that stabilizes neuronal membranes by reducing sodium ion influx. Mediocon Inc manufactures this high-purity API at its GMP-certified facility in Aurangabad, Maharashtra, India. It is used to control tonic-clonic seizures and focal seizures, and is also used in the treatment of trigeminal neuralgia.

• Control of tonic-clonic (grand mal) seizures
• Prevention and treatment of focal (partial) seizures
• Management of status epilepticus (IV formulations)
• Treatment of trigeminal neuralgia in select cases

• 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 Phenytoin — CAS 57-41-0 (CAS 57-41-0) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Phenytoin — CAS 57-41-0 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