|
Details
|
Specifications
|
|---|---|
|
CAS Number
|
594839-88-0
|
|
Molecular Formula
|
C14H7Cl2NO3
|
|
Molecular Weight
|
308.11 g/mol.
|
|
Synonyms
|
2-(3,5-Dichlorophenyl) benzoxazole-6-carboxylic acid
|
|
Chemical Name
|
2-(3,5-dichlorophenyl)-1,3-benzoxazole-6-carboxylic acid
|
|
Therapeutic use
|
Tafamidis is indicated to treat cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis in adults.
|
|
Status
|
Tech pack available
|
|
Background
|
Tafamidis and tafamidis meglumine (FX-1006A) are benzoxazole derivatives developed by FoldRX. Tafamidis is structurally similar to diflusinal. Tafamidis was granted an EMA market authorization on 16 November 2011 and FDA approval on 3 May 2019.
|
|
Grade
|
In-house
|
|
Polymorph
|
Form I
|
|
Storage Temperature
|
Controlled room temperature (20?C ? 25?C)
|
Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*Â
Disclaimer:Â
The information provided on this webpage is based on the best available knowledge at the time of publication; however, accuracy and completeness are not guaranteed. Product specifications may change without notice. It is the responsibility of the purchaser or user to verify suitability and compliance. This product is intended for research use only and is not approved for human consumption.
Tafamidis is a transthyretin (TTR) stabiliser, an oral small-molecule active pharmaceutical ingredient (API) used to treat a rare and serious protein-misfolding disease called transthyretin amyloidosis. It works by holding the transthyretin protein together so it cannot break apart and form harmful deposits in the heart and nerves. The reference brands are Vyndaqel and Vyndamax, and Tafamidis is one of the fastest-growing cardiology and rare-disease molecules in the world.
Shilpa Pharma is a trusted Tafamidis API manufacturer and supplier in India, developing this molecule at cGMP-compliant, globally audited facilities. A full technical package is available, and Shilpa Pharma supports generic developers who are preparing Tafamidis programs for launch as patents expire across global markets.
Key specifications
As a science-led pharmaceutical API manufacturer in India, Shilpa Pharma combines strong process chemistry, tight quality control, and world-class API manufacturing in India to deliver Tafamidis API that meets demanding international standards.
Tafamidis API is used to manufacture prescription medicines for transthyretin amyloidosis (ATTR), a rare disease in which a faulty protein builds up in the body. Approved uses of Tafamidis-based drugs include transthyretin amyloid cardiomyopathy (ATTR-CM), covering both the wild-type and hereditary forms, and transthyretin amyloid polyneuropathy (ATTR-PN), a nerve-damaging form of the disease.
The molecule belongs to the transthyretin stabiliser class. In simple terms, the transthyretin (TTR) protein normally travels as a stable group of four units. In ATTR amyloidosis, this protein breaks apart, misfolds, and forms deposits called amyloid in the heart and nerves. Tafamidis binds to the TTR protein and keeps its four units locked together, which slows the formation of these deposits and the progression of the disease.
For formulation, Tafamidis is developed as an oral soft capsule, commonly taken once daily (the free-acid form is used at a 61 mg strength). Shilpa Pharma supplies Tafamidis API with a defined solid-state form (Form I) and controlled particle size to support stable, reproducible formulation development.
Shilpa Pharma can supply Tafamidis API and related API intermediates for research, development, and regulatory filing, and is ready to scale up through integrated CDMO services for future commercial supply. All supply is aligned with the regulatory and intellectual property position in each market.
Tafamidis is manufactured under controlled cGMP conditions, using trained personnel, defined containment, and protective measures that safeguard both product quality and operator safety. Shilpa Pharma applies rigorous process controls at every stage to ensure a consistent, high-quality API.
On product safety, Shilpa Pharma places strong focus on impurity control and full analytical characterisation. Sensitive analytical methods keep impurities, including any genotoxic impurities, within safe, regulator-approved limits, and every batch is supported by complete quality and stability documentation.
From a clinical reference point, Tafamidis is known for a favourable safety profile and is generally well tolerated. In clinical studies, side-effect rates were broadly similar to placebo, and the medicine does not carry a boxed warning, which sets it apart from many other advanced therapies. Standard prescribing precautions still apply. This information is shared only as scientific reference for drug developers and is not medical advice.
Shilpa Pharma supplies Tafamidis API strictly to licensed pharmaceutical manufacturers, biotech firms, and authorised partners, with full documentation to support safe and compliant use in finished drug products.
Tafamidis API pricing is shared on request. Because API cost depends on order volume, development stage, delivery timelines, target market, and regulatory requirements, Shilpa Pharma provides a customised quotation for every enquiry rather than a fixed list price.
To receive current Tafamidis API pricing, availability, and documentation (including the technical package and impurity data), please contact the Shilpa Pharma team. Minimum order quantities apply, and Shilpa Pharma partners exclusively with pharmaceutical manufacturers, biotech companies, and authorised trading firms.
Email: info@shilpapharma.com | Request a Quote
Choosing the right Tafamidis API supplier means choosing quality, compliance, and readiness. Here is why global pharmaceutical companies trust Shilpa Pharma:
With decades of proven expertise and world-class API manufacturing in India, Shilpa Pharma is the partner of choice for companies developing advanced therapies for transthyretin amyloidosis. For an early Tafamidis API supplier or a long-term manufacturing partner, Shilpa Pharma delivers integrity, quality, and global performance.
Partner with a trusted Tafamidis manufacturer in India. Contact Shilpa Pharma today.
Happy Customers
Projects Successfully Completed
Established
PhD Experts Driving R&D Excellence
Team Size
World-Class API Manufacturing Sites
Global Audits Successfully Completed
Comprehensive CDMO Service Offerings
Everything You Need to Know About Shilpa Pharma
Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*
