Active Pharmaceutical Ingredient

Natalizumab API Manufacturer & Supplier in India

Also known as: Tysabri

CAS: 189261-10-7 Humanized Monoclonal Antibody Injection / IV / USP GMP Certified Aurangabad, Maharashtra, India
Natalizumab API — Mediocon Inc
Natalizumab — Pharmaceutical Grade API

Product Overview

CAS No: 189261-10-7  |  MF: C₆₄₈₄H₁₀₀₁₈N₁₇₄₄O₂₀₂₂S₄₄  |  MW: ~149,000 Da

Mirtazapine is a pharmaceutical-grade active ingredient classified as Humanized Monoclonal Antibody. Mediocon Inc supplies high-purity Mirtazapine API conforming to Injection / IV / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Key Features

  • Anti-α4 integrin monoclonal antibody
  • IV / USP injection grade
  • Full CoA and MSDS documentation
  • GMP certified biologic manufacturing

Applications

  • Relapsing-remitting multiple sclerosis
  • Crohn's disease (moderate to severe)
  • Prevention of disability progression in MS

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 NameNatalizumab
Also Known AsTysabri
CAS Number189261-10-7
Chemical NameAnti-α4-integrin humanized IgG4 monoclonal antibody
Molecular FormulaC₆₄₈₄H₁₀₀₁₈N₁₇₄₄O₂₀₂₂S₄₄
Molecular Weight~149,000 Da
CategoryNaSSA Antidepressant
AppearanceClear to slightly opalescent, colorless to slightly yellow solution
SolubilitySoluble in aqueous buffered solution
GradeInjection / IV / USP

Analytical Specifications

ParameterSpecification
AssayNLT 95.0% (protein content)
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
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 Natalizumab (CAS 189261-10-7) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Natalizumab 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 — Natalizumab API

What is the minimum order quantity for Natalizumab API?
Mediocon Inc supplies Natalizumab 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 Natalizumab does Mediocon supply?
We supply Natalizumab conforming to Injection / IV / 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 Natalizumab API?
Every shipment of Natalizumab 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 Natalizumab bulk orders?
Standard lead time for Natalizumab 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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