Active Pharmaceutical Ingredient

Pilsicainide API Manufacturer & Supplier in India

Also known as: SUN 1165; Sunrhythm

GMP Certified IP / BP / USP Antiarrhythmic Agent (Class IC) Aurangabad, India
Pilsicainide API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Pilsicainide IP / BP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 102970-55-4

Product Overview

Pilsicainide is a Class IC antiarrhythmic drug that blocks sodium channels. Manufactured by Mediocon Inc in Aurangabad, Maharashtra, India under GMP conditions, it is used in the treatment of cardiac arrhythmias, particularly atrial fibrillation and atrial flutter. CAS No: 102970-55-4.

Therapeutic Applications
  • Treatment and prevention of paroxysmal atrial fibrillation
  • Management of atrial flutter
  • Treatment of ventricular arrhythmias
  • Maintenance of sinus rhythm post cardioversion

Technical Specifications

ParameterSpecification
CAS Number102970-55-4
Molecular FormulaC18H23N3O
Molecular Weight297.40 g/mol
GradeIP / BP / USP
CategoryAntiarrhythmic Agent (Class IC)
AppearanceWhite to off-white crystalline powder
SolubilityFreely soluble in water, soluble in methanol, slightly soluble in ethanol.
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 2026
Exp DateFEB 2031
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: IP / BP / 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

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 Pilsicainide — CAS 102970-55-4 (CAS 102970-55-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Pilsicainide — CAS 102970-55-4 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 — Pilsicainide — CAS 102970-55-4 API

What is the minimum order quantity for Pilsicainide — CAS 102970-55-4 API?
Mediocon Inc supplies Pilsicainide — CAS 102970-55-4 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 Pilsicainide — CAS 102970-55-4 does Mediocon supply?
We supply Pilsicainide — CAS 102970-55-4 conforming to IP / BP / 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 Pilsicainide — CAS 102970-55-4 API?
Every shipment of Pilsicainide — CAS 102970-55-4 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 Pilsicainide — CAS 102970-55-4 bulk orders?
Standard lead time for Pilsicainide — CAS 102970-55-4 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.

Request a Quote

Minimum Order: 1 kg (sample available)
Export to 40+ countries worldwide
Full documentation: CoA, MSDS, COO
Lead Time: 2–4 weeks (standard)
WhatsApp: +91 9309999757
akshay@mediocon.com
 Get Bulk Quote  Request CoA / MSDS

Quick Reference

CAS No102970-55-4
FormulaC18H23N3O
MW297.40 g/mol
GradeIP / BP / USP
CategoryAntiarrhythmic Agent (Class IC)

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