Active Pharmaceutical Ingredient

Pilsicainide Hydrochloride API Manufacturer in India

CAS: 88069-40-3 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Pilsicainide Hydrochloride API Manufacturer in India — Mediocon Inc
Pilsicainide Hydrochloride API Manufacturer in India

Product Overview

CAS No: 88069-40-3 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Pilsicainide Hydrochloride API Manufacturer & Supplier

MEDIOCON INC is a trusted manufacturer, exporter, and bulk supplier of Pilsicainide Hydrochloride API (Active Pharmaceutical Ingredient), delivering pharmaceutical-grade material suitable for formulation development, analytical testing, quality control laboratories, research applications, and regulated pharmaceutical manufacturing. Manufactured under stringent quality standards, our Pilsicainide Hydrochloride API is supplied with complete documentation including COA, MSDS, and other regulatory support documents upon request.

Pilsicainide Hydrochloride is a Class IC antiarrhythmic active pharmaceutical ingredient primarily used in pharmaceutical formulations intended for the management of cardiac arrhythmias. It is recognized for its high sodium channel blocking activity and is widely utilized in cardiovascular pharmaceutical research and formulation development. MEDIOCON INC supplies consistently high-quality API that meets international quality standards and customer specifications.

Our manufacturing process follows strict GMP-oriented quality systems with comprehensive testing carried out by qualified analytical laboratories. Every batch undergoes identity testing, assay determination, impurity profiling, moisture analysis, residual solvent evaluation, heavy metal testing, and microbiological quality assessment wherever applicable.

MEDIOCON INC serves pharmaceutical manufacturers, formulation companies, contract development organizations (CDMOs), research laboratories, government institutions, and healthcare companies across domestic and international markets. We offer reliable logistics, competitive pricing, technical support, and prompt worldwide delivery for bulk requirements.

Whether your organization requires Pilsicainide Hydrochloride API for commercial production, pharmaceutical development, stability studies, validation batches, or research purposes, MEDIOCON INC is committed to providing consistent product quality and dependable supply.

Product Specifications

Product NamePilsicainide Hydrochloride API Manufacturer in India
CAS Number88069-40-3
CategoryActive Pharmaceutical Ingredient
GradeIP / BP / EP / USP
AppearanceWhite to Off-White Crystalline Powder
StandardsIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AppearanceWhite to Off-White Crystalline Powder
IdentificationIR & HPLC Complies
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 0.5%
Residue on IgnitionNMT 0.2%
Heavy MetalsNMT 10 ppm
pH (1% Solution)4.0 – 6.5
Individual ImpurityNMT 0.5%
Total ImpuritiesNMT 1.5%
Water ContentNMT 0.5%
Melting Point265°C – 275°C
SolubilityFreely soluble in Water; Slightly soluble in Methanol

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 Hydrochloride API Manufacturer in India (CAS 88069-40-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Pilsicainide Hydrochloride API Manufacturer in India 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 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
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Pilsicainide Hydrochloride API Manufacturer in India

What is Pilsicainide Hydrochloride API used for?
Pilsicainide Hydrochloride API is primarily used in the development of pharmaceutical formulations for the treatment of cardiac arrhythmias and cardiovascular research applications.
💬
Mediocon AI
Hello 👋 How can I help you today?