Cefuroxime Axetil API Manufacturer in Maharashtra, India

Cephalosporin Antibiotic – Manufacturer and Bulk Supplier in Maharashtra for Antibacterial Oral And Parenteral Formulations

Cefuroxime Axetil API Manufacturer and Bulk Supplier in Maharashtra, India – Swapnroop Pharma

Product Specifications

Product Name: Cefuroxime Axetil API
CAS Number: 64544-07-6
Category: Active Pharmaceutical Ingredient
Grade: Cefuroxime Axetil IP / BP / EP / USP
Appearance: White to off-white crystalline powder
Standards: IP / BP / EP / USP compliant

Detailed Specifications

ParameterSpecification
AppearanceWhite to off-white crystalline powder
IdentificationIR & HPLC compliant
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 1.0%
Residue on IgnitionNMT 0.2%
Heavy MetalsNMT 10 ppm
pH (1% Solution)2.0 – 4.0
Individual Impurity≤ 0.5%
Total Impurities≤ 1.5%

Cefuroxime Axetil API (CAS No: 64544-07-6)

WHO-GMP Certified Cefuroxime Axetil API Manufacturer in Maharashtra, India

Cefuroxime Axetil API (CAS 64544-07-6) is an Active Pharmaceutical Ingredient used in the formulation of prescription and/or over-the-counter pharmaceutical products. Swapnroop Drugs and Pharmaceuticals manufactures and supplies Cefuroxime Axetil API with pharmacopeial compliance (IP/BP/EP/USP as applicable) from our WHO-GMP certified facility in Aurangabad (MIDC Shendra), Maharashtra — one of India's premier pharmaceutical manufacturing zones with robust regulatory infrastructure.

Pharmaceutical formulation companies sourcing Cefuroxime Axetil API require consistent polymorphic or salt form characterisation, batch-to-batch HPLC purity ≥98% (or per specific pharmacopeial monograph), validated residual solvent control per ICH Q3C, and full impurity profiling against pharmacopeial limits. Our quality control laboratory performs complete pharmacopeial testing with USP/EP/IP validated analytical methods before every batch release.

Swapnroop's Cefuroxime Axetil API supply is backed by WHO-GMP certified manufacturing, a qualified vendor documentation package (CoA, MSDS, Certificate of Origin, stability data), and dedicated technical support for domestic formulation companies and international export customers. We maintain inventory for rapid order fulfilment across 25+ countries served from our Aurangabad facility.

Key Features

  • HPLC purity ≥98.0% (or per specific IP/BP/USP monograph for Cefuroxime Axetil)
  • Complete pharmacopeial testing: identification, assay, impurities, LOD, residue on ignition
  • Residual solvent control per ICH Q3C with validated GC/headspace methodology
  • WHO-GMP certified batch with full documentation package for regulatory submissions

Applications

  • Pharmaceutical tablet and capsule formulation development using Cefuroxime Axetil API
  • Injectable or parenteral formulation programs where Cefuroxime Axetil is indicated
  • R&D, pilot batch, and commercial manufacturing for domestic and regulated markets
  • Fixed-dose combination (FDC) drug product development programs

Why Choose Swapnroop for Cefuroxime Axetil?

  • WHO-GMP certified Aurangabad facility with CDSCO-approved manufacturing unit
  • Complete qualified vendor documentation: CoA, MSDS, CoO, stability reports
  • Export capability to 25+ countries with pharmacopeial-grade API
  • Responsive technical support and dedicated account management for long-term buyers

Packaging & Supply

Cefuroxime Axetil API is supplied in double-polyethylene-lined HDPE drums or fiber drums (25 kg net) with desiccant and nitrogen head-space. Smaller quantities (1 kg, 5 kg) in sealed HDPE jars for R&D programs. All packaging labelled with batch, grade, and pharmacopeial standard.

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Frequently Asked Questions about Cefuroxime Axetil API

What is the CAS number for Cefuroxime Axetil API?

The CAS number for Cefuroxime Axetil is 64544-07-6. It is a Cephalosporin Antibiotic used in pharmaceutical antibacterial oral and parenteral formulations.

What therapeutic class does Cefuroxime Axetil belong to?

Cefuroxime Axetil is classified as a Cephalosporin Antibiotic. It is used in antibacterial oral and parenteral formulations and is an established API in both domestic Indian and international pharmaceutical markets.

What grades and purity specifications are available for Cefuroxime Axetil API?

Cefuroxime Axetil API is available in IP, BP, EP, and USP pharmacopeial grades with HPLC purity ≥98.0–102.0%, complete related substances profiling, and residual solvent analysis per ICH Q3C guidelines.

What is the minimum order quantity and lead time for Cefuroxime Axetil API?

Minimum order is 1 kg for sampling and 25 kg for commercial bulk supply. Standard lead time is 2–4 weeks from our Aurangabad, Maharashtra facility. Larger volumes may be available from existing stock.

Is DMF-grade documentation available for Cefuroxime Axetil API?

Yes, Swapnroop provides complete DMF-grade documentation for Cefuroxime Axetil API including Certificate of Analysis (CoA), MSDS, impurity profile, residual solvent certificate, and regulatory filing support for USFDA, EMA, and CDSCO submissions.

Cefuroxime Axetil API Bulk Supplier in Aurangabad, Maharashtra, India

Swapnroop Drugs and Pharmaceuticals is a trusted Cefuroxime Axetil API manufacturer and bulk supplier in Aurangabad, Maharashtra, serving pharmaceutical formulation companies across India and 25+ international markets. Our WHO-GMP certified facility provides consistent Cefuroxime Axetil API supply with full pharmacopeial compliance, competitive pricing, and complete regulatory documentation for domestic and export programs.

Cefuroxime Axetil API Exporter from India – Regulatory Filing Support

As a Cefuroxime Axetil API exporter from Maharashtra, India, Swapnroop supports pharmaceutical companies worldwide with DMF-grade documentation, Certificate of Analysis, MSDS, impurity profiles, and regulatory filing assistance for USFDA, EMA, and CDSCO submissions. Contact us for Cefuroxime Axetil API pricing, samples, and sourcing support.