Mycophenolate API Manufacturer India

Name: Mycophenolate
Brand: Mediocon Inc
Availability: InStock

Mycophenolate — Pharmaceutical Grade API

Product Overview

CAS No: 24280-93-1 | MF: C₁₇H₂₀O₆ | MW: 320.34 g/mol

Mirtazapine is a pharmaceutical-grade active ingredient classified as Immunosuppressant. Mediocon Inc supplies high-purity Mycophenolate conforming to IP / BP / EP / USP specifications, manufactured in our GMP-certified facility in Aurangabad, Maharashtra, India.

Key Features

IMPDH inhibitor immunosuppressant
IP/BP/EP/USP compliant
Full CoA and MSDS documentation
GMP certified manufacturing

Applications

Prevention of organ transplant rejection
Lupus nephritis
Autoimmune conditions

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 NameMycophenolate

Also Known AsCellCept; Myfortic

CAS Number24280-93-1

Chemical Name(4E)-6-(4-hydroxy-6-methoxy-7-methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)-4-methylhex-4-enoic acid

Molecular FormulaC₁₇H₂₀O₆

Molecular Weight320.34 g/mol

CategoryNaSSA Antidepressant

AppearanceWhite to off-white crystalline powder

SolubilitySlightly soluble in water; soluble in methanol

GradeIP / BP / EP / USP

Analytical Specifications

Parameter	Specification
Assay	NLT 98.0%
Loss on Drying	NMT 0.5%
Heavy Metals	NMT 20 ppm
Residue on Ignition	NMT 0.1%
Microbial Limits	Complies with pharmacopoeia
Identification	IR, HPLC Compliant
Packing	25 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 Mycophenolate (CAS 24280-93-1) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Mycophenolate 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 — Mycophenolate API

What is the minimum order quantity for Mycophenolate API?

Mediocon Inc supplies Mycophenolate 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 Mycophenolate does Mediocon supply?

We supply Mycophenolate 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 Mycophenolate API?

Every shipment of Mycophenolate 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 Mycophenolate bulk orders?

Standard lead time for Mycophenolate 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.

Company

Product Catalog

Mycophenolate API Manufacturer & Supplier in India

Product Overview

Product Specifications

Analytical Specifications

Sourcing, Regulatory & Export Information

Frequently Asked Questions — Mycophenolate API

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