Active Pharmaceutical Ingredient

Nalidixic Acid API Manufacturer & Supplier

CAS: 389-08-2 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Nalidixic Acid API Manufacturer & Supplier — Mediocon Inc
Nalidixic Acid API Manufacturer & Supplier

Product Overview

CAS No: 389-08-2 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Nalidixic Acid API Manufacturer & Supplier

MEDIOCON INC is a trusted global manufacturer and supplier of Nalidixic Acid API, offering premium-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, formulation development, analytical testing, quality control, stability studies, and research applications. Every batch is manufactured under stringent quality management systems to ensure exceptional purity, consistency, and compliance with international pharmaceutical standards.

Nalidixic Acid is a first-generation quinolone antibacterial active pharmaceutical ingredient widely used in pharmaceutical formulations for the treatment of urinary tract infections (UTIs) caused by susceptible Gram-negative bacteria. It acts by inhibiting bacterial DNA gyrase and topoisomerase II enzymes, thereby preventing bacterial DNA replication and cell division. Nalidixic Acid has also been extensively utilized in microbiological research, pharmaceutical formulation development, analytical method validation, process optimization, stability studies, and quality assurance programs.

MEDIOCON INC supplies premium-quality Nalidixic Acid API to pharmaceutical manufacturers, formulation companies, contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), universities, research institutes, and analytical laboratories worldwide. Comprehensive documentation including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and regulatory support documents is available upon request.

Product Specifications

Product NameNalidixic Acid API Manufacturer & Supplier
CAS Number389-08-2
CategoryActive Pharmaceutical Ingredient
GradeIP / BP / EP / USP
AppearanceWhite to Pale Yellow Crystalline Powder
StandardsIP / BP / EP / USP Compliant

Analytical Specifications

ParameterSpecification
AppearanceWhite to Pale Yellow Crystalline Powder
IdentificationIR, UV & HPLC Compliant
Assay (HPLC)98.5% – 101.5%
Loss on DryingNMT 0.50%
Residue on IgnitionNMT 0.10%
Heavy MetalsNMT 10 ppm
pH (1% Solution)5.0 – 7.0
Individual ImpurityNMT 0.50%
Total ImpuritiesNMT 1.00%
Water ContentNMT 0.50%
Melting Point227°C – 231°C
SolubilitySlightly soluble in water; freely soluble in dilute alkali solutions and 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 Nalidixic Acid API Manufacturer & Supplier (CAS 389-08-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Nalidixic Acid API Manufacturer & Supplier 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 — Nalidixic Acid API Manufacturer & Supplier

What is Nalidixic Acid API?
Nalidixic Acid API is a first-generation quinolone antibacterial active pharmaceutical ingredient used in pharmaceutical formulations for treating urinary tract infections and bacterial infections.
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