Active Pharmaceutical Ingredient

Pegloticase — CAS N/A (Biologic PEGylated Uricase) API Manufacturer & Supplier in India

Also known as: Krystexxa; PEG-uricase

GMP Certified I.P. / B.P. / E.P. / U.S.P. Uricase Enzyme / Biologic / Anti-Gout Agent Aurangabad, India
Pegloticase API Supplier Manufacturer Aurangabad Maharashtra India — Mediocon Inc
Pegloticase I.P. / B.P. / E.P. / U.S.P.  |  GMP Certified  |  Mediocon Inc, Maharashtra, India
CAS No: N/A (Biologic PEGylated Uricase)

Product Overview

Pegloticase is a high-purity Active Pharmaceutical Ingredient (API) classified as a Uricase Enzyme / Biologic / Anti-Gout Agent. Manufactured by Mediocon Inc in Aurangabad, Maharashtra, India at a GMP-certified facility, it is supplied in bulk for pharmaceutical formulations worldwide. CAS No: N/A (Biologic PEGylated Uricase).

Therapeutic Applications
  • Chronic refractory gout unresponsive to conventional therapy
  • Tophaceous gout reduction
  • Hyperuricemia management in gout
  • Uric acid lowering in gout flares
  • Biologic therapy for severe gout

Technical Specifications

ParameterSpecification
CAS NumberN/A (Biologic PEGylated Uricase)
Molecular FormulaPEGylated Uricase (Recombinant)
Molecular Weight~540 kDa
GradeI.P. / B.P. / E.P. / U.S.P.
CategoryUricase Enzyme / Biologic / Anti-Gout Agent
AppearanceWhite to off-white crystalline powder
SolubilitySlightly soluble in water; soluble in methanol
AssayNLT 98.0%
Loss on DryingNMT 0.5%
Heavy MetalsNMT 20 ppm
Residue on IgnitionNMT 0.1%
Microbial LimitsComplies with pharmacopoeia
IdentificationIR, HPLC Compliant
Batch NoPGL2503021
Mfg DateMAR 2025
Exp DateFEB 2030
Packing25 kg HDPE drums / as per requirement

Quality & Compliance

  • GMP Certified manufacturing facility in Aurangabad, Maharashtra, India
  • Full pharmacopoeial compliance: I.P. / B.P. / E.P. / U.S.P. standards
  • Complete documentation: Certificate of Analysis (CoA), MSDS, Certificate of Origin
  • Stringent in-process quality control at every manufacturing stage
  • HPLC purity testing and spectroscopic identification (IR, NMR)
  • Cold-chain and controlled-environment storage facilities available
  • Exported to 40+ countries with full regulatory support

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 Pegloticase — CAS N/A (Biologic PEGylated Uricase) (pharmaceutical grade) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Pegloticase — CAS N/A (Biologic PEGylated Uricase) 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 — Pegloticase — CAS N/A (Biologic PEGylated Uricase) API

What is the minimum order quantity for Pegloticase — CAS N/A (Biologic PEGylated Uricase) API?
Mediocon Inc supplies Pegloticase — CAS N/A (Biologic PEGylated Uricase) 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 Pegloticase — CAS N/A (Biologic PEGylated Uricase) does Mediocon supply?
We supply Pegloticase — CAS N/A (Biologic PEGylated Uricase) conforming to I.P. / B.P. / E.P. / U.S.P. 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 Pegloticase — CAS N/A (Biologic PEGylated Uricase) API?
Every shipment of Pegloticase — CAS N/A (Biologic PEGylated Uricase) 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 Pegloticase — CAS N/A (Biologic PEGylated Uricase) bulk orders?
Standard lead time for Pegloticase — CAS N/A (Biologic PEGylated Uricase) 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 NoN/A (Biologic PEGylated Uricase)
FormulaPEGylated Uricase (Recombinant)
MW~540 kDa
GradeI.P. / B.P. / E.P. / U.S.P.
CategoryUricase Enzyme / Biologic / Anti-Gout Agent

Related APIs

Pelitinib Methotrexate Nilutamide Nevirapine
View All APIs →
💬
Mediocon AI✖
Hello 👋 How can I help you today?