Active Pharmaceutical Ingredient

Safinamide (CAS 147098-20-2) API Manufacturer & Supplier in India

Also known as: Safinamide Mesilate; Xadago

CAS: 147098-20-2 Antiparkinson / MAO-B Inhibitor IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Safinamide API — Mediocon Inc, Aurangabad Maharashtra India
Safinamide — Pharmaceutical Grade API | Mediocon Inc, Aurangabad, Maharashtra, India

Product Overview

CAS No: 147098-20-2  |  MF: C₁₇H₁₉FN₂O₂  |  MW: 302.35 g/mol

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

Product Specifications

Product NameSafinamide
Also Known AsSafinamide Mesilate; Xadago
CAS Number147098-20-2
Molecular FormulaC₁₇H₁₉FN₂O₂
Molecular Weight302.35 g/mol
CategoryAntiparkinson / MAO-B Inhibitor
AppearanceWhite to off-white crystalline powder
SolubilitySlightly soluble in water; soluble in methanol
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Mfg DateMAR 2025
Exp DateFEB 2030
Packing25 kg HDPE drums / as per requirement

Sourcing, Regulatory & Export Information

Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Safinamide (CAS 147098-20-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Safinamide 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

Frequently Asked Questions — Safinamide API

What is the minimum order quantity for Safinamide API?
Mediocon Inc supplies Safinamide with a minimum order quantity of 1 kg (sample packs available for R&D). We accommodate both small R&D quantities and large commercial-scale orders. Contact our sales team at akshay@mediocon.com or +91 9309999757 for a tailored quote.
What pharmacopoeial grades of Safinamide does Mediocon supply?
We supply Safinamide conforming to IP / BP / EP / USP pharmacopoeial standards. Each batch is tested against full pharmacopoeial specifications and released with a Certificate of Analysis. Custom specifications can be accommodated for regulated markets.
What documentation is provided with Safinamide API?
Every shipment of Safinamide comes with: Certificate of Analysis (CoA), MSDS/SDS, Certificate of Origin (COO), and Drug Master File (DMF) support on request. We also provide GMP certification, ISO 9001:2015 compliance documentation, and full regulatory support for filings in USA (FDA), Europe (EMA), and other markets.
What is the lead time and shipping for Safinamide bulk orders?
Standard lead time for Safinamide is 2–4 weeks for standard orders; expedited shipments possible for urgent requirements. We ship to 40+ countries worldwide using approved pharmaceutical-grade packaging (25 kg HDPE drums / aluminium foil bags). All shipments include temperature-controlled logistics options where required by the product's storage conditions.
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