Caffeine API Manufacturer & Supplier in India

Caffeine is a natural methylxanthine stimulant found in coffee, tea, and cola nuts. Pharmaceutically, it is used for the treatment of neonatal apnea, as an analgesic adjuvant, and in various CNS formulations. Mediocon Inc supplies pharmaceutical-grade Caffeine (Anhydrous) meeting IP/BP/EP/USP standards with a minimum assay of 99.5%.

Key Features

• Pure methylxanthine stimulant (99.5% min assay)
• IP/BP/EP/USP compliant quality
• Used in neonatal apnea and analgesic formulations
• Suitable for oral, injectable, and topical applications

Applications

• Neonatal apnea treatment (IV/oral)
• Analgesic combination tablets
• Energy formulations and nutraceuticals
• CNS stimulant preparations

Why Choose Mediocon

• ISO 9001:2015 & GMP certified manufacturing
• Consistent batch-to-batch quality with full CoA
• Export-ready documentation: COO, MSDS, DMF
• Flexible MOQ for both R&D and commercial scale
• Dedicated QA support for regulatory filings

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Caffeine (CAS 58-08-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Caffeine 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