Birch Triterpenes 10% w/w Suppliers & Bulk Manufacturers
Available Forms: Topical Gel
Available Strengths: 10% w/w
Reference Brands: Filsuvez (USA/EU)
Category: Derma Drugs
Birch Triterpenes is a Derma Drugs product available as Topical Gel in strengths 10% w/w. It corresponds to the reference brand Filsuvez (USA/EU). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.
Product Description:
Birch triterpenes, marketed under the brand name Filsuvez, is a topical medication derived from the bark of silver birch (Betula pendula) and downy birch. It is specifically formulated for the treatment of partial-thickness skin wounds in patients with epidermolysis bullosa, a rare inherited condition that causes extremely fragile skin, severe blistering, and scarring. The active components are pentacyclic triterpenes extracted from birch bark, which promote wound healing, protect damaged skin, and support the regeneration of the upper layers of the skin.
Filsuvez is indicated for use in individuals aged six months and older with dystrophic epidermolysis bullosa and junctional epidermolysis bullosa, targeting wounds where the epidermis has been partially damaged. The formulation leverages the natural healing properties of birch triterpenes to accelerate recovery, reduce pain, and minimize the risk of infection in affected areas. Recognized by the U.S. Food and Drug Administration as a first-in-class medication, Filsuvez represents a breakthrough in the management of epidermolysis bullosa, offering patients a safe, effective, and non-invasive option to improve skin integrity and quality of life.
Birch Triterpenes — third party manufacturing & bulk supply
Birch Triterpenes 10% w/w 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:
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 Birch Triterpenes 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.
Request a quote for Birch Triterpenes →The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Birch triterpenes, formulated as Filsuvez gel, are used for the treatment of partial-thickness wounds associated with dystrophic and junctional epidermolysis bullosa. They help promote wound healing and protect damaged skin.
Birch triterpenes are extracted from the bark of birch trees (Betula species) and purified to obtain bioactive pentacyclic triterpenoids, including betulin, which are formulated into a 10% w/w topical gel.
The primary medicinal trade name is Filsuvez.
Filsuvez is manufactured by Amryt Pharma.
The generic name is birch triterpenes.
The brand name is Filsuvez.
Filsuvez is manufactured in Europe under licensed pharmaceutical facilities and is distributed in the USA, EU, and UK.
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