Active Pharmaceutical Ingredient

Ciprofloxacin API Manufacturer & Supplier in India

Also known as: Cipro (brand)

CAS: 85721-33-1 Fluoroquinolone Antibiotic USP / BP / IP Bulk Supply Available
Ciprofloxacin API Manufacturer India | Mediocon Inc
Ciprofloxacin — Pharmaceutical Grade API

Product Overview

CAS No: 85721-33-1  |  MF: C₁₇H₁₈FN₃O₃  |  MW: 331.34 g/mol

Ciprofloxacin is a broad-spectrum fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV. It is highly effective against both gram-negative and gram-positive bacteria and is used for urinary tract infections, respiratory infections, gastrointestinal infections, anthrax, and more. Mediocon Inc supplies pharmaceutical-grade Ciprofloxacin meeting IP/BP/EP/USP standards.

Key Features

  • Broad-spectrum fluoroquinolone antibiotic
  • IP/BP/EP/USP compliant, Assay 99.0% Min.
  • Effective against wide range of gram-negative pathogens
  • Suitable for oral tablet, IV, and ophthalmic formulations

Applications

  • Oral tablets and IV infusion for infections
  • Urinary tract infection treatment
  • Ophthalmic drops for eye infections
  • Anthrax prophylaxis and treatment

Why Choose Mediocon

  • ISO 9001:2015 & GMP certified manufacturing
  • Consistent batch-to-batch quality with full CoA
  • Export-ready documentation: COO, MSDS, DMF
  • Flexible MOQ for both R&D and commercial scale
  • Dedicated QA support for regulatory filings

Product Specifications

Product NameCiprofloxacin
Also Known AsCipro (brand)
CAS Number85721-33-1
Molecular FormulaC₁₇H₁₈FN₃O₃
Molecular Weight331.34 g/mol
CategoryAntibiotic / Fluoroquinolone
AppearanceWhite to Off-White Crystalline Powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay99.0% Min.
Loss on DryingNMT 0.5%
Heavy MetalsNMT 10 ppm
pH (0.5% solution)3.0 – 4.5
Microbial LimitsComplies with pharmacopoeia
Packing25 kg HDPE drums / as per requirement

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 Ciprofloxacin (CAS 85721-33-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Ciprofloxacin 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 — Ciprofloxacin API

What is the minimum order quantity for Ciprofloxacin API?
Mediocon Inc supplies Ciprofloxacin 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 Ciprofloxacin does Mediocon supply?
We supply Ciprofloxacin conforming to IP / BP / EP / 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 Ciprofloxacin API?
Every shipment of Ciprofloxacin 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 Ciprofloxacin bulk orders?
Standard lead time for Ciprofloxacin 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.
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