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Birch Triterpenes bulk supplier for pharma manufacturers

Birch Triterpenes Suppliers & Bulk Manufacturers

Available Forms: Topical Gel

Available Strengths: 10% w/w

Reference Brands: Filsuvez (USA/EU)

Category: Derma Drugs

Birch Triterpenes is available in Topical Gel and strengths such as 10% w/w. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Birch Triterpenes is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.

Technical Specifications & Supply Details
Lead Time 7 to 60 days (depending on batch size & schedule)
MOQ As per manufacturer’s batch size
COA Available with every batch
Regulatory Dossier / DMF Available upon request
Export Documentation FSC, COA, Manufacturing License, Product Permission
Standards IP, BP, USP
Certifications WHO-GMP, EU-GMP, USFDA (as applicable)

Birch Triterpenes can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.

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📘 Sourcing Guide

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.

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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.

Yes, Birch Triterpenes is available with DMF and other regulatory documents such as COA and MSDS. These can be provided upon request for qualified buyers.

Absolutely. Sample requests are accepted for formulation trials and quality checks. Please submit an enquiry to initiate the process.

Our manufacturing partners are GMP-certified and comply with ISO and WHO standards, ensuring global quality benchmarks.

Lead times vary based on quantity and destination, but most orders are fulfilled within 1–3 weeks. Express shipping options are available.

Yes, Birch Triterpenes is exported to over 30 countries across Asia, Africa, Europe, and Latin America. We support documentation for customs and regulatory clearance.

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