Active Pharmaceutical Ingredient

Phenazopyridine Hydrochloride API Manufacturer & Bulk Supplier in India

CAS: 136-40-3 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Phenazopyridine Hydrochloride API Manufacturer & Bulk Supplier in India — Mediocon Inc
Phenazopyridine Hydrochloride API Manufacturer & Bulk Supplier in India

Product Overview

CAS No: 136-40-3 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Phenazopyridine Hydrochloride API Manufacturer & Supplier

MEDIOCON INC is a trusted manufacturer, exporter, and bulk supplier of Phenazopyridine Hydrochloride API (Active Pharmaceutical Ingredient), delivering premium pharmaceutical-grade raw material for formulation development, pharmaceutical manufacturing, analytical testing, quality control laboratories, stability studies, and authorized research applications. Our API is produced under stringent quality management systems to ensure exceptional purity, consistency, and compliance with international pharmaceutical standards.

Phenazopyridine Hydrochloride is a urinary tract analgesic active pharmaceutical ingredient widely used in pharmaceutical formulations intended to provide symptomatic relief from pain, burning, urgency, irritation, and discomfort associated with urinary tract infections (UTIs) and other urinary tract conditions. It is commonly utilized in pharmaceutical formulation development, analytical method validation, stability studies, and regulated research applications. MEDIOCON INC supplies high-quality Phenazopyridine Hydrochloride API suitable for commercial pharmaceutical manufacturing and research purposes.

Each production batch undergoes comprehensive quality evaluation including identity confirmation, HPLC assay, impurity profiling, moisture determination, residual solvent testing, heavy metal analysis, and additional quality assessments where applicable. Our robust quality assurance system ensures batch-to-batch consistency and dependable product performance.

MEDIOCON INC serves pharmaceutical manufacturers, formulation companies, contract manufacturing organizations (CMOs), research institutes, healthcare organizations, and distributors across domestic and international markets. We offer competitive pricing, dependable bulk supply, worldwide logistics support, and complete regulatory documentation including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), and additional technical documents upon request.

Whether your organization requires Phenazopyridine Hydrochloride API for commercial manufacturing, pharmaceutical formulation development, analytical testing, stability studies, or research applications, MEDIOCON INC is committed to delivering superior quality products with reliable customer support and timely global delivery.

Product Specifications

Product NamePhenazopyridine Hydrochloride API Manufacturer & Bulk Supplier in India
CAS Number136-40-3
CategoryActive Pharmaceutical Ingredient
GradeIP / BP / EP / USP
AppearanceOrange-Red to Dark Red Crystalline Powder
StandardsIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
AppearanceOrange-Red to Dark Red 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)2.5 – 4.5
Individual ImpurityNMT 0.5%
Total ImpuritiesNMT 1.5%
Water ContentNMT 0.5%
Melting Point195°C – 200°C
SolubilityFreely soluble in Water; Slightly soluble in Ethanol

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 Phenazopyridine Hydrochloride API Manufacturer & Bulk Supplier in India (CAS 136-40-3) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Phenazopyridine Hydrochloride API Manufacturer & Bulk Supplier 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 — Phenazopyridine Hydrochloride API Manufacturer & Bulk Supplier in India

What is Phenazopyridine Hydrochloride API used for?
Phenazopyridine Hydrochloride API is widely used in pharmaceutical formulations intended for symptomatic relief of urinary tract discomfort and in pharmaceutical research, analytical testing, and formulation development.
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