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Active Pharmaceutical Ingredient

Cerliponase Alfa API Manufacturer & Supplier in India

Also known as: Brineura (brand)

CAS: 1465549-79-4 Enzyme Replacement Rare Disease Bulk Supply Available
Capsules IP 500 mg
Cerliponase Alfa — Pharmaceutical Grade API

Product Overview

CAS No: 1465549-79-4  |  MF: N/A (Recombinant Enzyme)  |  MW: ~66 kDa

Cerliponase Alfa is a recombinant form of human tripeptidyl peptidase 1 (TPP1) enzyme used for the treatment of neuronal ceroid lipofuscinosis type 2 (CLN2 disease), a rare and fatal lysosomal storage disorder in children. It is administered directly into the cerebrospinal fluid via intraventricular infusion. Mediocon Inc supplies pharmaceutical-grade Cerliponase Alfa API for biopharmaceutical manufacturers.

Key Features

  • Recombinant TPP1 enzyme replacement
  • IP/BP/EP/USP compliant quality
  • Treats CLN2 (Batten disease variant)
  • Intraventricular CSF administration

Applications

  • CLN2 neuronal ceroid lipofuscinosis treatment
  • Rare pediatric neurology
  • Intraventricular enzyme infusion
  • Biopharmaceutical formulation

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 NameCerliponase Alfa
Also Known AsBrineura (brand)
CAS Number1465549-79-4
Molecular FormulaN/A (Recombinant Enzyme)
Molecular Weight~66 kDa
CategoryEnzyme Replacement Therapy / Rare Disease
AppearanceLyophilized Powder / Solution
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Purity≥ 98% (by SEC-HPLC)
EndotoxinNMT 0.5 EU/mg
BioburdenComplies
IdentificationPeptide Mapping Compliant
Storage2–8°C
PackingAs per requirement

Frequently Asked Questions — Cerliponase Alfa API

What is the minimum order quantity for Cerliponase Alfa API?
Mediocon Inc supplies Cerliponase Alfa 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 Cerliponase Alfa does Mediocon supply?
We supply Cerliponase Alfa 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 Cerliponase Alfa API?
Every shipment of Cerliponase Alfa 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 Cerliponase Alfa bulk orders?
Standard lead time for Cerliponase Alfa 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.

Request a Quote

Minimum Order: 1 kg (sample available)
Export to 40+ countries worldwide
Full documentation: CoA, MSDS, COO
Lead Time: 2–4 weeks (standard)
WhatsApp: +91 9309999757
akshay@mediocon.com
 Get Bulk Quote  Request CoA / MSDS

Quick Reference

CAS No1465549-79-4
FormulaN/A (Recombinant Enzyme)
MW~66 kDa
GradeIP / BP / EP / USP
Assay98.0% Min.

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