Aminolevulinic Acid Hydrochloride API Manufacturer & Supplier in India

Aminolevulinic Acid Hydrochloride is a pharmaceutical-grade Active Pharmaceutical Ingredient in the Photosensitiser / PDT Agent category. Mediocon Inc supplies high-purity Aminolevulinic Acid Hydrochloride API (CAS 5451-09-2) from our GMP-certified facility in Aurangabad, Maharashtra, India. We cater to pharmaceutical manufacturers, formulators, and research organisations worldwide.

Primary uses include: Photodynamic therapy of actinic keratosis; fluorescence-guided resection of glioblastoma. Mediocon's Aminolevulinic Acid Hydrochloride meets the highest pharmacopoeial standards and is manufactured under WHO-GMP compliant conditions for consistent quality and purity.

Key Features

• High-purity pharmaceutical grade API (NLT 98.0% assay)
• IP / BP / EP / USP compliant with full analytical verification
• Full CoA, MSDS/SDS, and COO documentation with every batch
• GMP certified manufacturing under ISO 9001:2015 QMS

Applications & Therapeutic Uses

• Photodynamic therapy of actinic keratosis; fluorescence-guided resection of glioblastoma
• Bulk pharmaceutical raw material for formulation manufacturers
• R&D and analytical reference grade supply available
• Export-ready for regulated markets (US FDA, EU EMA, WHO)

Why Choose Mediocon

• ISO 9001:2015 & WHO-GMP certified manufacturing
• Consistent batch-to-batch quality with full CoA
• Export-ready documentation: COO, MSDS, DMF support
• Flexible MOQ — 1 kg minimum (R&D samples available)
• Dedicated QA support for regulatory filings (FDA, EMA, WHO)

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Aminolevulinic Acid Hydrochloride (CAS 5451-09-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Aminolevulinic Acid Hydrochloride is manufactured under strict quality management protocols compliant with WHO-GMP, ISO 9001:2015, and major pharmacopoeial standards (IP / BP / EP / USP). 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