Tafamidis Meglumine

Tafamidis Meglumine is a pivotal pharmaceutical API and analytical reference standard in the treatment of transthyretin amyloidosis, functioning as a selective TTR kinetic stabilizer with disease-modifying activity . As a pharmacological chaperone, Tafamidis Meglumine binds with high affinity to both wild-type and variant transthyretin tetramers, kinetically stabilizing the protein and preventing its dissociation into misfolded monomers that form amyloid fibrils . Tafamidis Meglumine demonstrates a unique binding mode with negative cooperativity—selectively occupying the two normally unoccupied thyroxine-binding sites on the TTR tetramer with dissociation constants (Kd) of approximately 2 nM and 200 nM . Tafamidis Meglumine received U.S. FDA approval in 2019 for the treatment of cardiomyopathy caused by transthyretin-mediated amyloidosis (ATTR-CM) . Tafamidis Meglumine has a molecular weight of 503.33 g/mol and is supplied as a white to off-white solid, soluble in DMSO at 2 mg/mL .

Product Parameters

Why Cosperpharm?

When your TTR amyloidosis API manufacturing campaign or ANDA filing requires reliable Tafamidis Meglumine, Cosperpharm delivers with the analytical rigor, documentation depth, and supply flexibility that pharmaceutical customers demand.

Consistent quality starts with the benzoxazole scaffold. Tafamidis Meglumine's complex molecular architecture—featuring a dichlorophenyl-substituted benzoxazole core paired with the meglumine counterion—demands rigorous quality control throughout synthesis. Any impurity or chiral deviation will compromise your final API's TTR binding affinity and clinical efficacy. Our analytical release protocol for Tafamidis Meglumine includes HPLC purity verification (≥98%), identity confirmation, and residual solvent analysis—because your final API's pharmacological profile depends on the quality of this chaperone scaffold.

Documentation that supports regulatory submission. As an API and reference standard, every Cosperpharm shipment of Tafamidis Meglumine includes a Certificate of Analysis (COA) with batch-specific HPLC purity, chromatographic traceability, and residual solvent data—structured for direct insertion into your method validation package. DMF-ready documentation, stability summaries, and custom quality agreements are available upon request.

Flexible supply across all development stages. Cosperpharm supplies Tafamidis Meglumine across the full range of applications—from milligram reference standard quantities for QC impurity profiling and analytical method development, to gram-scale batches for process validation, to bulk quantities for commercial manufacturing. R&D samples ship within 5–7 business days; bulk orders ship within 2–3 weeks.

Technical support for the full synthetic cascade. Our process chemistry team can advise on synthetic route optimization—including the acid-catalyzed cyclization approach and salt formation with N-methyl-D-glucamine—impurity profiling, and analytical methods for detecting process-related impurities . We have extensive experience with this benzoxazole scaffold across multiple manufacturing campaigns.

Global reach with transparent pricing. Cosperpharm ships to pharmaceutical manufacturers, CROs, and analytical laboratories worldwide, with full customs documentation included. Volume discounts apply at larger scales, and we communicate lead times upfront—no hidden fees, no unexpected delays.

FAQ

Q1: What is Tafamidis Meglumine used for?

A: Tafamidis Meglumine is indicated for the treatment of cardiomyopathy caused by transthyretin-mediated amyloidosis (ATTR-CM) in adults. It functions as a selective TTR kinetic stabilizer that prevents the misfolding and aggregation of transthyretin protein .

Q2: What is the mechanism of action of Tafamidis Meglumine?

A: Tafamidis Meglumine binds to the thyroxine-binding sites of the transthyretin (TTR) tetramer with high affinity (Kd ~2 nM), kinetically stabilizing the tetramer and preventing its dissociation into monomers. This inhibits the formation of TTR amyloid fibrils and prevents their deposition in peripheral nerve tissues and organs .

Product Quality Assurance

Cosperpharm has established a comprehensive quality assurance system for Tafamidis Meglumine that meets the rigorous expectations of both API manufacturing and reference standard applications:

Thorough analytical characterization. Each batch undergoes multi-technique analytical release testing: HPLC purity (≥98%), appearance verification (white to off-white solid), residual solvent analysis (GC), identity confirmation (NMR, MS), and water content determination .

Full batch traceability with retention samples. From raw material procurement through synthesis, salt formation, crystallization, drying, and final packaging, every step is fully documented and traceable. Each batch receives a unique lot number with sufficient retention samples maintained in accordance with Cosperpharm quality procedures.

Stability monitoring program. Cosperpharm conducts ongoing stability studies under recommended storage conditions: 2–8 °C for short term, –20 °C for long term. Stability summaries are updated regularly, with full data packages available to support customer regulatory submissions.

Documentation ready for regulatory submission. Every shipment includes a Certificate of Analysis (COA) with batch-specific purity and characterization data, a Material Safety Data Sheet (SDS), and customs documentation for international delivery. For customers preparing ANDA or NDA filings, Cosperpharm provides DMF-ready documentation packages, method validation reports, stability data, and custom quality agreements upon request.

Customer-initiated quality audits. Qualified customers are welcome to audit Cosperpharm's manufacturing, quality control, and documentation facilities. Please contact our regulatory team to schedule an audit.

Contact Us

Interested in Tafamidis Meglumine for your ATTR amyloidosis API program, impurity reference standard needs, or TTR stabilization research? Cosperpharm is here to support your project. Contact our team today for a quote, technical documentation, or to discuss your specific requirements—we're ready to partner with you.