Acoramidis Hydrochloride

Category
Details
Specifications
CAS Number
2242751-53-5
Molecular Formula
C15H18ClFN2O3
Molecular Weight
328.77 g/mol.
Synonyms
Acoramidis Hydrochloride
Chemical Name
3-[3-(3,5-dimethyl-1H-pyrazol-4-yl) propoxy]-4-fluorobenzoic acid hydrochloride
Therapeutic use
Transthyretin (TTR) Stabilizer
Status
Tech pack available
Background
Acoramidis hydrochloride (brand name Attruby) is an oral, highly selective transthyretin (TTR) stabilizer approved by the FDA in Nov 2024 to treat transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM).
Grade
In house
Polymorph
Form A
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* 

Disclaimer: 

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.

Acoramidis hydrochloride (CAS 2242751-53-5) is an orally active, highly selective transthyretin (TTR) stabilizer developed for the treatment of transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM). Approved by the US FDA in November 2024, acoramidis works by binding and stabilizing the TTR tetramer, mimicking a naturally protective genetic variant to prevent the tetramer from dissociating into the misfolded monomers that deposit as amyloid in cardiac tissue. By preserving TTR stability, it helps slow the progression of this serious, progressive cardiomyopathy.

With a molecular formula of C₁₅H₁₈ClFN₂O₃ and a molecular weight of 328.77 g/mol, acoramidis hydrochloride is a small-molecule benzoic acid derivative supplied in the crystalline Form A polymorph. As one of the newest approved therapies in the rapidly expanding ATTR-CM market, the molecule has driven strong global demand for reliable acoramidis hydrochloride manufacturers and suppliers across regulated and emerging markets.

As established API manufacturers in India, Shilpa Pharma Lifesciences supplies acoramidis hydrochloride as a bulk active pharmaceutical ingredient to pharmaceutical and biotechnology partners worldwide. Backed by a complete technical package and integrated CDMO services, Shilpa Pharma supports global partners from early development through commercial-scale manufacturing and supply.

Acoramidis hydrochloride is supplied as a drug substance (bulk API) for use by pharmaceutical and biotechnology manufacturers in the development and production of oral solid dosage forms for ATTR-CM. As an orally administered TTR stabilizer, the molecule binds at the thyroxine-binding sites of the transthyretin tetramer, increasing its kinetic stability and reducing the formation of amyloidogenic species that drive disease progression in both wild-type (ATTRwt) and hereditary, variant (ATTRv) forms of the condition.

In a development and manufacturing context, the API supports formulation and oral solid dosage (tablet) development, analytical method development and validation, impurity profiling and reference standard qualification, polymorph and stability studies, and scale-up to clinical and commercial supply. The defined crystalline Form A supplied by Shilpa Pharma supports consistent solid-state quality and reproducible processing during oral dosage form development.

As established acoramidis hydrochloride suppliers, Shilpa Pharma provides material exclusively to qualified pharmaceutical manufacturers, biotechnology companies, and international trading partners for development and manufacturing use under applicable regulatory frameworks.

In clinical use, acoramidis is generally well tolerated, with the most commonly reported adverse effects being gastrointestinal in nature, including diarrhoea and upper abdominal pain; these are typically mild. As acoramidis is used to manage a chronic cardiac condition, treatment is initiated and monitored by qualified clinicians in accordance with the approved product information, and dosing decisions rest with the prescribing physician.

From a handling and occupational-safety standpoint, acoramidis hydrochloride should be handled by trained personnel using appropriate engineering controls and personal protective equipment in accordance with the product’s Safety Data Sheet (SDS). The API should be stored at controlled room temperature (20°C to 25°C), protected from moisture and light, to maintain stability and quality.

This information is provided for scientific and technical reference to pharmaceutical professionals and does not constitute medical advice.

The cost of acoramidis hydrochloride varies according to order volume, required specifications, packaging, documentation, and delivery destination. As bulk API pricing is project- and quantity-specific, Shilpa Pharma does not publish standard list pricing for this product.

For current acoramidis hydrochloride pricing, bulk quantity cost estimates, and commercial supply terms, pharmaceutical and biotechnology buyers are invited to contact Shilpa Pharma directly. As trusted acoramidis hydrochloride suppliers and exporters, our team provides a tailored quotation based on your required quantity, grade, and regulatory documentation needs, along with competitive, cost-effective supply options for both development-scale and commercial-scale requirements.

Shilpa Pharma Lifesciences is one of the most trusted acoramidis hydrochloride manufacturers in India and a full-scale CDMO partner, supplying high-quality active pharmaceutical ingredients to pharmaceutical and biotech companies across more than 80 countries. For acoramidis hydrochloride, partners choose Shilpa Pharma for:

  • Regulatory-ready manufacturing: produced at cGMP-compliant facilities supported by approvals from USFDA, EU GMP, PMDA, TGA, ANVISA, COFEPRIS, and KFDA.
  • Complete technical package: a ready tech pack that accelerates partner evaluation, formulation development, and regulatory filings.
  • Integrated CDMO capability: end-to-end support from route and process development to analytical characterisation and commercial-scale supply.
  • Solid-state and analytical expertise: defined Form A polymorph control, impurity profiling, and method development for consistent, formulation-ready quality.
  • Reliable global supply: scalable capacity with established export, logistics, and documentation infrastructure, positioning Shilpa Pharma among dependable acoramidis hydrochloride suppliers and exporters for regulated and emerging markets.
  • Decades of expertise: IP-sensitive, transparent collaboration backed by a proven track record in API manufacturing.

Partner with Shilpa Pharma, a trusted acoramidis hydrochloride manufacturer and exporter, for a dependable, scalable, and cost-effective global source of this API.

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Questions & Answers

FAQ on Acoramidis Hydrochloride

Everything You Need to Know About Shilpa Pharma

Acoramidis received US FDA approval in November 2024 for transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM). As an innovator molecule, it remains under patent protection, so commercial generic supply depends on patent expiry and exclusivity in each market. Shilpa Pharma supplies acoramidis hydrochloride API to qualified partners for development, evaluation, and regulatory-readiness purposes under applicable laws.
Acoramidis is indicated for the treatment of adults with cardiomyopathy caused by transthyretin-mediated amyloidosis (ATTR-CM), covering both wild-type and hereditary forms. By stabilizing the TTR protein, it helps slow disease progression and reduce cardiovascular events. Shilpa Pharma supplies the API for formulation development and manufacturing.
Acoramidis binds at the thyroxine-binding sites of the transthyretin tetramer and increases its kinetic stability, mimicking a naturally occurring protective TTR variant. This reduces the dissociation of the tetramer into misfolded monomers that aggregate into amyloid fibrils, which is the underlying driver of cardiac damage in ATTR-CM.
Both acoramidis and tafamidis are oral TTR stabilizers used in ATTR-CM, but they differ in their binding and stabilization profile and dosing schedule, with acoramidis designed as a highly selective, near-complete stabilizer of the TTR tetramer. The clinical choice between agents rests with the treating physician; for API buyers, Shilpa Pharma can supply both molecules to support different development programs.
Acoramidis hydrochloride carries CAS number 2242751-53-5, with the molecular formula C₁₅H₁₈ClFN₂O₃ and a molecular weight of 328.77 g/mol. It is a benzoic acid derivative supplied in the crystalline Form A polymorph, with a complete technical package available on request.
Many developers source innovator molecules early for research, formulation development, and regulatory dossier preparation under research-use and Bolar-type provisions that exist in several markets. As one of the leading acoramidis hydrochloride manufacturers in India, Shilpa Pharma supplies the API to qualified pharmaceutical manufacturers for such development use; buyers should confirm the patent position in each target territory.
Shilpa Pharma supplies acoramidis hydrochloride as the defined crystalline Form A. A consistent, well-characterised polymorph is important for reproducible dissolution, stability, manufacturability, and regulatory acceptance of the finished oral dosage form, which is why solid-state control is a core part of Shilpa Pharma’s offering.
A complete technical package is available now to support evaluation and formulation development. As programs advance toward commercial supply, Shilpa Pharma provides full regulatory documentation support, including Drug Master File and CEP preparation as required, drawing on facilities approved by USFDA, EU GMP, PMDA, TGA, ANVISA, COFEPRIS, and KFDA.
Shilpa Pharma Lifesciences is among the leading API manufacturers in India and global exporters, supplying acoramidis hydrochloride to pharmaceutical and biotech partners worldwide. Its cGMP-compliant facilities hold approvals for major regulated markets, enabling supply with supporting documentation across the USA, Europe, Japan, and 80+ countries, subject to applicable regulatory and patent considerations in each market.
Yes. Through its integrated CDMO services, Shilpa Pharma can support the full pathway from route and process development to finished oral solid dosage development, analytical characterisation, polymorph and impurity control, and scale-up from development to commercial volumes, all under a single regulatory umbrella. This positions Shilpa Pharma among the few acoramidis hydrochloride manufacturers offering integrated development-to-commercial supply.

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Please Note: We partner exclusively with pharmaceutical manufacturers, biotech companies, and international trading firms. Minimum order quantities apply*