Active Pharmaceutical Ingredient

Entecavir API Manufacturer & Supplier in India

High-purity Entecavir API — GMP Certified

CAS: 142217-69-4 IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Entecavir API Manufacturer In India — Mediocon Inc
Entecavir API Manufacturer In India — Pharmaceutical Grade API

Product Overview

CAS No: 142217-69-4  |  MF: C12H15N5O3  |  MW: 277.28

Entecavir is a potent antiviral nucleoside analogue used in the treatment of chronic hepatitis B virus (HBV) infection. Mediocon Inc manufactures Entecavir API to IP/BP/EP/USP standards in its GMP-certified facility in Aurangabad, Maharashtra, India.

Our Entecavir API is supplied to global pharmaceutical manufacturers with full regulatory documentation. Mediocon supports both small R&D quantities and large commercial-scale supply chains.

Key Features

  • High-purity pharmaceutical grade API
  • IP / BP / EP / USP compliant
  • Full CoA and MSDS documentation
  • GMP certified manufacturing

Applications

  • Chronic hepatitis B treatment
  • Antiviral formulation manufacturing
  • Liver disease management
  • Antiviral pharmaceutical research

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 NameEntecavir
CAS Number142217-69-4
Molecular FormulaC12H15N5O3
Molecular Weight277.28
CategoryActive Pharmaceutical Ingredient
AppearanceWhite to off-white crystalline powder
GradeIP / BP / EP / USP
Batch NoPEMD/24032026
Mfg DateMAR 2026
Exp DateFEB 2031
Quantity25.00 Kg
Gross Weight26.00 Kg

Analytical Specifications

ParameterSpecification
AssayNLT 98.0%
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 Entecavir (CAS 142217-69-4) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Entecavir 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 — Entecavir API

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