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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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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.

How Elamipretide Hydrochloride is supplied today, and licensing ahead of patent expiry

Where elamipretide is approved

Checked 3 Oct 2026
MarketStatusBrand · regulator · date
United States Approved Forzinity · FDA · Sep 2025 (accelerated)
Generic / biosimilar None None approved as of the check date

Not approved in your country? A hospital or doctor can often still import it for a named patient, through a special-access, import-permit or compassionate-use route. We confirm which route applies in your country and the documents needed before quoting. Ask about named-patient supply →

Named-patient import Where a patient needs the product in a market where it is not registered, named-patient import is the lawful route. It requires the treating physician's documentation and authorisation from the destination regulator. We handle this pathway. Named-patient access
Authorised distribution For registered markets, supply runs through the manufacturer's authorised distribution channel. We can identify the authorised route for your market and tell you whether the product is registered there at all. Innovator sourcing
A genericised alternative Where the clinical requirement is the drug class rather than this specific molecule, there is often an off-patent alternative that is faster to register and materially cheaper. Tell us the indication and target market and we will say plainly whether one exists. Discuss alternatives
Licensing and generic development Patents expire country by country, and in many countries development and dossier filing can start before expiry under research and regulatory-review exemptions. We connect manufacturers developing this molecule, dossier holders, licensees and tech-transfer partners for markets where it is, or will become, off-patent. Partner on this molecule
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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.

Forzinity (Elamipretide) is developed and sold by Stealth BioTherapeutics. PharmaTradz handles enquiries for authorised supply of the originator product, named-patient import where it is not registered, and licensing or development work ahead of patent expiry.

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