Safinamide

Safinamide is a selective, reversible monoamine oxidase B (MAO-B) inhibitor used as adjunct therapy for Parkinson's disease. Mediocon Inc supplies pharmaceutical-grade Safinamide conforming to IP / BP / EP / USP specifications from our GMP-certified facility in Aurangabad, Maharashtra, India.

Safinamide works by selectively inhibiting MAO-B, thereby increasing dopamine levels in the brain. It is indicated as add-on therapy to levodopa in mid-to-late stage Parkinson's patients experiencing fluctuations.

Key Features

• High-purity pharmaceutical grade API
• IP / BP / EP / USP compliant
• Full CoA and MSDS documentation
• GMP certified manufacturing facility

Applications

• Parkinson's disease adjunct therapy
• MAO-B inhibitor formulations
• CNS drug development
• Neurological disorder R&D

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

Parameter	Specification
Assay	NLT 98.0%
Loss on Drying	NMT 0.5%
Heavy Metals	NMT 20 ppm
Residue on Ignition	NMT 0.1%
Microbial Limits	Complies with pharmacopoeia
Identification	IR, HPLC Compliant
Mfg Date	MAR 2025
Exp Date	FEB 2030
Packing	25 kg HDPE drums / as per requirement