Active Pharmaceutical Ingredient

Mifamurtide API Manufacturer & Supplier in India | MEDIOCON INC

CAS: 83461-56-7 Active Pharmaceutical Ingredient Pharmaceutical Grade GMP Certified Aurangabad, Maharashtra, India
Mifamurtide API Manufacturer & Supplier in India | MEDIOCON INC — Mediocon Inc
Mifamurtide API Manufacturer & Supplier in India | MEDIOCON INC

Product Overview

CAS No: 83461-56-7 | Grade: Pharmaceutical Grade | Category: Active Pharmaceutical Ingredient

Mifamurtide API Manufacturer & Supplier in India

MEDIOCON INC is a trusted global manufacturer and supplier of Mifamurtide API in India, offering high-quality pharmaceutical-grade active pharmaceutical ingredients for oncology pharmaceutical manufacturing, formulation development, analytical testing, quality control, stability studies, and research applications. Our APIs are supplied with appropriate quality documentation and are intended for pharmaceutical manufacturers, formulation developers, research organizations, and other qualified industry users.

Mifamurtide, also known as Muramyl Tripeptide Phosphatidylethanolamine (MTP-PE) or L-MTP-PE, is a synthetic immunomodulatory compound derived from muramyl dipeptide. It stimulates innate immune responses primarily through activation of monocytes and macrophages. Mifamurtide is associated with activation of the NOD2 innate immune pathway and subsequent production of inflammatory mediators involved in macrophage and monocyte activation.

Mifamurtide is used as an immunostimulatory component in the treatment of high-grade, resectable, non-metastatic osteosarcoma in children, adolescents, and young adults. The European Medicines Agency states that Mepact, containing mifamurtide, is used after macroscopically complete surgical resection and in combination with postoperative multi-agent chemotherapy.

Mifamurtide is available in different chemical representations, including Mifamurtide (MTP-PE) and Mifamurtide Sodium / Sodium Hydrate. PubChem identifies the sodium-hydrate representation with CAS Number 838853-48-8, molecular formula C₅₉H₁₁₀N₆NaO₂₀P, and molecular weight 1277.5 g/mol. Research-grade Mifamurtide itself is also listed as CAS 83461-56-7, with molecular weight 1237.5 g/mol and purity of 98.0% by a current commercial reference listing.

Due to its immunomodulatory activity and application in oncology research, Mifamurtide is utilized in pharmaceutical formulation development, oncology research, analytical method development, process development, quality control, stability studies, and pharmaceutical research programs. MEDIOCON INC supplies Mifamurtide API to pharmaceutical manufacturers, contract manufacturing organizations (CMOs), contract research organizations (CROs), biotechnology companies, formulation companies, universities, research institutes, and analytical laboratories worldwide, supported with applicable COA, MSDS/SDS, technical data sheets, analytical documentation, and product specifications.

Product Specifications

Product NameMifamurtide API Manufacturer & Supplier in India | MEDIOCON INC
CAS Number83461-56-7
CategoryActive Pharmaceutical Ingredient
GradePharmaceutical Grade
AppearanceWhite to Off-White Solid / Powder
StandardsPharmaceutical Specifications

Analytical Specifications

ParameterSpecification
AppearanceWhite to Off-White Solid / Powder
IdentificationIR / HPLC / LC-MS Complies
Assay (HPLC)NLT 98.0%
Loss on DryingNMT 5.0%
Residue on IgnitionNMT 2.0%
Heavy MetalsNMT 20 ppm
pH (1% Solution)6.0 – 8.0
Individual ImpurityNMT 1.0%
Total ImpuritiesNMT 2.0%
Water ContentNMT 5.0%
SolubilitySoluble in DMSO; limited aqueous solubility

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 Mifamurtide API Manufacturer & Supplier in India | MEDIOCON INC (CAS 83461-56-7) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.

Our Mifamurtide API Manufacturer & Supplier in India | MEDIOCON INC 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 — Mifamurtide API Manufacturer & Supplier in India | MEDIOCON INC

What is Mifamurtide API?
Mifamurtide API is an immunomodulatory active pharmaceutical ingredient and a synthetic derivative of muramyl dipeptide. It stimulates innate immune responses by activating monocytes and macrophages and is associated with NOD2-mediated immune signaling.
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