Active Pharmaceutical Ingredient

Procainamide Hydrochloride API Manufacturer & Supplier in India

Also known as: Pronestyl; Procanbid

GMP Certified IP / BP / USP Class IA Antiarrhythmic Agent Aurangabad, India
Procainamide Hydrochloride API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Procainamide Hydrochloride IP / BP / USP  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: 614-39-1

Product Overview

Procainamide Hydrochloride is a Class IA antiarrhythmic agent that blocks sodium channels in cardiac tissue, thereby reducing automaticity and prolonging the refractory period. It is used intravenously for the management of acute ventricular arrhythmias and atrial fibrillation. Mediocon Inc manufactures Procainamide Hydrochloride API at its GMP-certified facility in Aurangabad, Maharashtra, India.

Therapeutic Applications
  • Treatment of life-threatening ventricular arrhythmias (VT, VF)
  • Management of atrial fibrillation and atrial flutter (cardioversion)
  • Treatment of WPW syndrome-associated tachyarrhythmias
  • Suppression of premature ventricular contractions (PVCs)

Technical Specifications

ParameterSpecification
CAS Number614-39-1
Molecular FormulaC13H21N3O · HCl
Molecular Weight271.79 g/mol
GradeIP / BP / USP
CategoryClass IA Antiarrhythmic Agent
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
Batch NoPROC/24032026
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 Procainamide Hydrochloride — CAS 614-39-1 (CAS 614-39-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Procainamide Hydrochloride — CAS 614-39-1 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 — Procainamide Hydrochloride — CAS 614-39-1 API

What is the minimum order quantity for Procainamide Hydrochloride — CAS 614-39-1 API?
Mediocon Inc supplies Procainamide Hydrochloride — CAS 614-39-1 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 Procainamide Hydrochloride — CAS 614-39-1 does Mediocon supply?
We supply Procainamide Hydrochloride — CAS 614-39-1 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 Procainamide Hydrochloride — CAS 614-39-1 API?
Every shipment of Procainamide Hydrochloride — CAS 614-39-1 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 Procainamide Hydrochloride — CAS 614-39-1 bulk orders?
Standard lead time for Procainamide Hydrochloride — CAS 614-39-1 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 No614-39-1
FormulaC13H21N3O · HCl
MW271.79 g/mol
GradeIP / BP / USP
CategoryClass IA Antiarrhythmic Agent

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