Active Pharmaceutical Ingredient

Albendazole API Manufacturer & Supplier in India

Also known as: Albenza

CAS: 54965-21-8 Anthelmintic / Antiparasitic USP / BP / IP Bulk Supply Available
Albendazole API Manufacturer India | Mediocon Inc
Albendazole — Pharmaceutical Grade API

Product Overview

CAS No: 54965-21-8  |  MF: C₁₂H₁₅N₃O₂S  |  MW: 265.33 g/mol

Albendazole is a broad-spectrum anthelmintic agent used for the treatment of various parasitic worm infections. It inhibits tubulin polymerization in helminths. Mediocon Inc supplies pharmaceutical-grade Albendazole meeting USP, BP, and IP standards for tablet and suspension formulations.

Key Features

  • Broad-spectrum anthelmintic
  • USP/BP/IP compliant quality
  • Effective against nematodes & cestodes
  • Suitable for tablet and suspension formulations

Applications

  • Hydatid disease tablets
  • Neurocysticercosis treatment
  • Intestinal parasitic infections
  • Filariasis combination therapy

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 NameAlbendazole
Also Known AsAlbenza
CAS Number54965-21-8
Molecular FormulaC₁₂H₁₅N₃O₂S
Molecular Weight265.33 g/mol
CategoryAnthelmintic / Antiparasitic
AppearanceWhite to Off-white Powder
GradeUSP / BP / IP

Analytical Specifications

ParameterSpecification
Assay98.0% – 102.0%
Loss on DryingNMT 0.5%
Melting Point208°C – 212°C
Heavy MetalsNMT 10 ppm
pHN/A
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
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 Albendazole (CAS 54965-21-8) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Albendazole 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 — Albendazole API

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