Active Pharmaceutical Ingredient

Mycophenolate Mofetil API Manufacturer & Supplier

CAS: 128794-94-5 Active Pharmaceutical Ingredient IP / BP / EP / USP GMP Certified Aurangabad, Maharashtra, India
Mycophenolate Mofetil API Manufacturer & Supplier — Mediocon Inc
Mycophenolate Mofetil API Manufacturer & Supplier

Product Overview

CAS No: 128794-94-5 | Grade: IP / BP / EP / USP | Category: Active Pharmaceutical Ingredient

Mycophenolate Mofetil API Manufacturer & Supplier

MEDIOCON INC is a trusted global manufacturer and supplier of Mycophenolate Mofetil API, offering premium-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, formulation development, analytical testing, quality control, stability studies, and research applications. Every batch is manufactured under stringent quality management systems to ensure exceptional purity, consistency, and compliance with international pharmaceutical standards.

Mycophenolate Mofetil is a potent immunosuppressive active pharmaceutical ingredient widely used in pharmaceutical formulations for the prevention of organ transplant rejection and the treatment of autoimmune disorders. It is the morpholinoethyl ester prodrug of mycophenolic acid and is rapidly converted to its active metabolite after administration. Mycophenolate Mofetil acts as a selective, reversible inhibitor of inosine monophosphate dehydrogenase (IMPDH), suppressing the proliferation of T and B lymphocytes by inhibiting de novo guanosine nucleotide synthesis. It is extensively prescribed in kidney, heart, and liver transplantation and is also used in the management of lupus nephritis and other immune-mediated diseases. Owing to its proven therapeutic efficacy, Mycophenolate Mofetil is widely utilized in pharmaceutical research, formulation development, analytical method validation, process optimization, stability studies, and quality assurance programs.

MEDIOCON INC supplies premium-quality Mycophenolate Mofetil API to pharmaceutical manufacturers, formulation companies, contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), universities, research institutes, and analytical laboratories worldwide. Comprehensive documentation including Certificate of Analysis (COA), Material Safety Data Sheet (MSDS), Technical Data Sheet (TDS), and regulatory support documents is available upon request.

 

Product Specifications

Product NameMycophenolate Mofetil API Manufacturer & Supplier
CAS Number128794-94-5
CategoryActive Pharmaceutical Ingredient
GradeIP / BP / EP / USP
AppearanceWhite to Off-White Crystalline Powder
StandardsIP / BP / EP / USP Compliant

Analytical Specifications

ParameterSpecification
AppearanceWhite to Off-White Crystalline Powder
IdentificationIR, UV & HPLC Compliant
Assay (HPLC)98.0% – 102.0%
Loss on DryingNMT 0.50%
Residue on IgnitionNMT 0.10%
Heavy MetalsNMT 10 ppm
pH (1% Solution)5.0 – 7.5
Individual ImpurityNMT 0.50%
Total ImpuritiesNMT 1.00%
Water ContentNMT 0.50%
Melting Point93°C – 97°C
SolubilityFreely soluble in acetone and methanol; soluble in ethanol; slightly soluble in water

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 Mofetil API Manufacturer & Supplier (CAS 128794-94-5) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Mycophenolate Mofetil API Manufacturer & Supplier 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 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
  • Dedicated QA team for customer audits and regulatory queries

Frequently Asked Questions — Mycophenolate Mofetil API Manufacturer & Supplier

What is Mycophenolate Mofetil API?
Mycophenolate Mofetil API is an immunosuppressive active pharmaceutical ingredient and a prodrug of mycophenolic acid used in pharmaceutical formulations to prevent organ transplant rejection and treat autoimmune diseases.
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