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Elamipretide Hydrochloride bulk supplier for pharma manufacturers

Elamipretide Hydrochloride 80 mg/mL Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 80 mg/mL

Reference Brands: Forzinity (USA)

Category: Critical Care

Elamipretide Hydrochloride is a Critical Care product available as Injection in strengths 80 mg/mL. It corresponds to the reference brand Forzinity (USA). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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📘 Sourcing Guide

Product Description:

Elamipretide, also known by its development codes SS-31 and MTP-131, and marketed under the brand name Forzinity, is a mitochondria-targeting therapeutic peptide used for the treatment of Barth syndrome. It is administered as a hydrochloride salt via subcutaneous injection and is indicated to improve muscle strength in patients with Barth syndrome weighing at least 30 kilograms (66 lb).

Elamipretide works by selectively binding to cardiolipin, a phospholipid located in the inner mitochondrial membrane, stabilizing mitochondrial structure and improving bioenergetic function. By enhancing mitochondrial efficiency and reducing oxidative stress, elamipretide helps patients with Barth syndrome gain better skeletal muscle performance, improved stamina, and overall physical function.

Barth syndrome is a rare, serious, and life-threatening mitochondrial disorder that primarily affects males. It often presents with severe heart failure in infancy and can lead to premature death. Survivors into adolescence and adulthood frequently experience fatigue, poor stamina, and exercise intolerance, significantly affecting their quality of life and daily functioning.

Elamipretide Hydrochloride — third party manufacturing & bulk supply

Elamipretide Hydrochloride 80 mg/mL is available through PharmaTradz for wholesale and bulk supply as well as on a third party (contract) manufacturing basis. Buyers sourcing this product generally take one of three routes:

Wholesale / bulk supply Stock or scheduled supply from an existing manufacturer. The fastest route where the product is already registered in your market.
Third party manufacturing Manufactured to your specification and packed under your own brand and label — suits distributors and brand owners building a portfolio in their market.
Dossier licensing Where a CTD, EU-CTD or ACTD dossier exists it can often be licensed for filing in your name, compressing market entry from years to months.

What to include when you enquire

  • Destination market — determines which manufacturers hold the right site-level approvals
  • First order quantity and estimated annual volume
  • Whether you need a registration dossier or the product is already registered
  • Packaging, labelling and language requirements
  • Incoterms and required shelf life

Manufacturers of Elamipretide Hydrochloride listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding. Narcotic drugs and controlled substances are supplied strictly against valid import and export permits issued by the competent authorities.

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Frequently Asked Questions


Elamipretide hydrochloride is used to treat Barth syndrome by improving mitochondrial function, physical performance, and skeletal and cardiac muscle strength in affected patients.


Elamipretide hydrochloride is a synthetic peptide designed to selectively target mitochondria and bind cardiolipin, enhancing mitochondrial structure and bioenergetic function.


The trade name of elamipretide hydrochloride is Forzinity.


Elamipretide hydrochloride (Forzinity) is manufactured by Stealth BioTherapeutics in the USA.


The generic name is elamipretide hydrochloride.


The brand name is Forzinity.


Elamipretide hydrochloride is manufactured in the USA by GMP-compliant facilities for specialized use in rare disease treatment programs.

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