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Casimersen bulk supplier for pharma manufacturers

Casimersen 50 mg/ml Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 50 mg/ml

Reference Brands: Amondys 45 (USA)

Category: Neurology

Casimersen is a Neurology product available as Injection in strengths 50 mg/ml. It corresponds to the reference brand Amondys 45 (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:

Casimersen, marketed under the brand name Amondys 45, is an antisense oligonucleotide medication specifically designed for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation of the dystrophin gene that is amenable to exon 45 skipping. It is a phosphorodiamidate morpholino oligomer (PMO) that targets dystrophin pre-mRNA, enabling the cellular machinery to skip the defective exon and produce a shortened but functional dystrophin protein.

Duchenne muscular dystrophy is a rare, progressive genetic disorder that primarily affects boys and is characterized by the absence or deficiency of dystrophin, a critical protein for muscle integrity and function. The lack of dystrophin leads to progressive muscle weakness, loss of mobility, and reduced life expectancy. Casimersen offers a targeted therapeutic approach by addressing the underlying genetic defect, aiming to slow disease progression and improve muscle function. The medication is administered via intravenous infusion under strict medical supervision, with treatment tailored to the patient’s specific genetic mutation and clinical condition.

Casimersen — third party manufacturing & bulk supply

Casimersen 50 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 Casimersen 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


Casimersen is used to treat Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 45 skipping. It helps restore the production of a shortened but functional dystrophin protein, which is essential for muscle function.


Casimersen is an antisense oligonucleotide designed to selectively bind to exon 45 of the dystrophin pre-mRNA. By modulating mRNA splicing, it allows the cellular machinery to skip the mutated exon and produce functional dystrophin.


Casimersen is marketed under the trade name Amondys 45 in the United States.


Amondys 45 is manufactured by Sarepta Therapeutics, a company specializing in genetic therapies for rare diseases.


The generic name is casimersen sodium.


Amondys 45 is the recognized brand name for casimersen.


Casimersen is manufactured in the United States under strict regulatory and GMP-compliant conditions by Sarepta Therapeutics.

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