MEDIOCON INC is a trusted API manufacturer and supplier in India of Migalastat API, offering high-quality pharmaceutical-grade active pharmaceutical ingredients for pharmaceutical manufacturing, formulation development, analytical testing, quality control, stability studies, and pharmaceutical research.
Migalastat is a pharmacological chaperone and low-molecular-weight iminosugar that selectively binds to certain mutant forms of the lysosomal enzyme alpha-galactosidase A (α-Gal A). By stabilizing amenable mutant forms of the enzyme, Migalastat facilitates their trafficking to lysosomes, where the enzyme can retain activity and help reduce the accumulation of globotriaosylceramide and related substrates associated with Fabry disease. The FDA describes Migalastat as an alpha-galactosidase A pharmacological chaperone.
Migalastat is present as the hydrochloride salt in the approved pharmaceutical product. Migalastat Hydrochloride is chemically identified as (+)-(2R,3S,4R,5S)-2-(hydroxymethyl)piperidine-3,4,5-triol hydrochloride and has the molecular formula C₆H₁₃NO₄·HCl, molecular mass 199.63 g/mol, and CAS Number 75172-81-5. The free Migalastat active moiety has CAS Number 108147-54-2.
Migalastat Hydrochloride is described as a white to almost white crystalline solid and is freely soluble in aqueous media over the pH range of approximately 1.2 to 7.5. The drug substance is a single chiral and polymorphic Form 1 and is reported as non-hygroscopic.
MEDIOCON INC supplies Migalastat API / Migalastat Hydrochloride for pharmaceutical manufacturers, formulation companies, biotechnology companies, contract research organizations (CROs), contract development and manufacturing organizations (CDMOs), analytical laboratories, research institutes, and pharmaceutical development programs. Applicable documentation including Certificate of Analysis (COA), MSDS/SDS, Technical Data Sheet (TDS), product specifications, analytical documentation, and relevant quality/regulatory documentation can be provided according to the product and intended application.
| Parameter | Specification |
|---|---|
| Appearance | White to Almost White Crystalline Solid |
| Identification | IR / HPLC / Chloride Complies |
| Assay (HPLC) | 98.0% – 102.0% |
| Residue on Ignition | NMT 0.20% |
| Heavy Metals | NMT 20 ppm |
| Individual Impurity | NMT 0.40% |
| Total Impurities | NMT 0.50% |
| Water Content | NMT 0.20% |
| Solubility | Freely soluble in aqueous media |
Mediocon Inc is a GMP-certified API manufacturer and bulk pharmaceutical ingredient supplier based in Aurangabad, Maharashtra, India. We specialise in supplying Migalastat API Manufacturer & Supplier in India | MEDIOCON INC (CAS 108147-54-2) and over 1,000 other Active Pharmaceutical Ingredients, excipients, herbal extracts, and nutraceutical ingredients to pharmaceutical manufacturers worldwide.
Our Migalastat 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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