MEDIOCON INC is a trusted global manufacturer and supplier of Miltefosine API in India, offering high-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, formulation development, analytical testing, quality control, stability studies, and research applications. Our APIs are supplied with appropriate quality documentation to support pharmaceutical development, manufacturing, and quality-assurance requirements.
Miltefosine is a phospholipid and alkylphosphocholine-class antiprotozoal active pharmaceutical ingredient. It is an orally active antileishmanial drug used in pharmaceutical formulations for the treatment of specific forms of visceral, cutaneous, and mucosal leishmaniasis. The U.S. FDA-approved labeling identifies miltefosine for visceral leishmaniasis caused by Leishmania donovani, cutaneous leishmaniasis caused by L. braziliensis, L. guyanensis, and L. panamensis, and mucosal leishmaniasis caused by L. braziliensis.
Miltefosine is also known as Hexadecylphosphocholine and has the molecular formula C₂₁H₄₆NO₄P, molecular weight 407.6 g/mol, and CAS Number 58066-85-6. PubChem identifies it as a phospholipid and member of the phosphocholine class. The official drug labeling describes miltefosine as a white powder that is freely soluble in water, 0.1 N hydrochloric acid or sodium hydroxide, methanol, and ethanol.
Miltefosine is utilized in pharmaceutical formulation development, antiprotozoal drug research, analytical method development, process development, quality control, stability studies, and pharmaceutical research programs. MEDIOCON INC supplies premium-quality Miltefosine API to pharmaceutical manufacturers, contract manufacturing organizations (CMOs), contract research organizations (CROs), formulation companies, biotechnology companies, universities, research institutes, and analytical laboratories worldwide, supported with comprehensive documentation including COA, MSDS, technical data sheets, product specifications, and applicable quality documentation.
| Parameter | Specification |
|---|---|
| Appearance | White Powder |
| Identification | IR / HPLC / LC-MS Complies |
| Assay (HPLC) | NLT 98.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 5.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | NMT 1.0% |
| Water Content | NMT 1.0% |
| Melting Point | 228°C – 230°C |
| Solubility | Freely Soluble in Water |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Miltefosine API Manufacturer & Supplier in India | MEDIOCON INC (CAS 58066-85-6) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Miltefosine 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.
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