Active Pharmaceutical Ingredient

Glecaprevir API Manufacturer & Supplier in India

Also known as: Mavyret (with Pibrentasvir)

CAS: 1365970-03-1 HCV NS3/4A Protease Inhibitor / Antiviral IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Glecaprevir API — Mediocon Inc
Glecaprevir — Pharmaceutical Grade API

Product Overview

CAS No: 1365970-03-1  |  MF: C38H46F4N6O9S  |  MW: 838.87 g/mol

Glecaprevir is a pan-genotypic HCV NS3/4A protease inhibitor used in combination with pibrentasvir for the treatment of chronic hepatitis C virus infection across all major genotypes. Mediocon Inc supplies pharmaceutical-grade Glecaprevir API.

Key Features

  • Pan-genotypic HCV NS3/4A protease inhibitor
  • Effective across HCV genotypes 1–6
  • IP/BP/EP/USP compliant
  • Full CoA and MSDS documentation

Applications

  • Chronic hepatitis C (all genotypes)
  • Antiviral combination therapy
  • HCV treatment regimens
  • Direct-acting antiviral formulations

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 NameGlecaprevir
Also Known AsMavyret (with Pibrentasvir)
CAS Number1365970-03-1
Molecular FormulaC38H46F4N6O9S
Molecular Weight838.87 g/mol
CategoryHCV NS3/4A Protease Inhibitor / Antiviral
AppearanceWhite to off-white crystalline powder
GradeIP / BP / EP / USP

Analytical Specifications

ParameterSpecification
Assay≥98.0% (as per pharmacopoeia)
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 Glecaprevir (CAS 1365970-03-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Glecaprevir 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 — Glecaprevir API

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