Active Pharmaceutical Ingredient

Nadifloxacin API Manufacturer & Supplier

CAS: 124858-35-1 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Nadifloxacin API Manufacturer & Supplier — Mediocon Inc
Nadifloxacin API Manufacturer & Supplier

Product Overview

CAS No: 124858-35-1 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Nadifloxacin API Manufacturer & Supplier

MEDIOCON INC is a trusted global manufacturer and supplier of Nadifloxacin API, offering premium-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, topical 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.

Nadifloxacin is a broad-spectrum fluoroquinolone antibacterial active pharmaceutical ingredient widely used in topical pharmaceutical formulations for the treatment of acne vulgaris and bacterial skin infections. It exerts its antibacterial activity by inhibiting bacterial DNA gyrase and topoisomerase IV, thereby preventing bacterial DNA replication and cell division. Nadifloxacin demonstrates potent activity against both Gram-positive and Gram-negative bacteria, including Propionibacterium acnes (now Cutibacterium acnes) and Staphylococcus aureus. Due to its excellent antimicrobial efficacy and dermatological safety profile, Nadifloxacin is extensively utilized in pharmaceutical research, formulation development, analytical method validation, process optimization, stability studies, and quality assurance programs.

MEDIOCON INC supplies premium-quality Nadifloxacin API to pharmaceutical manufacturers, dermatology 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 NameNadifloxacin API Manufacturer & Supplier
CAS Number124858-35-1
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)98.0% – 102.0%
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 Point250°C – 255°C
SolubilitySlightly soluble in water; soluble in methanol and dimethyl sulfoxide (DMSO)

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 Nadifloxacin API Manufacturer & Supplier (CAS 124858-35-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Nadifloxacin 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 — Nadifloxacin API Manufacturer & Supplier

What is Nadifloxacin API?
Nadifloxacin API is a fluoroquinolone antibacterial active pharmaceutical ingredient used in topical pharmaceutical formulations for acne vulgaris and bacterial skin infections.
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