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 10% oleogel, a birch bark extract gel for partial-thickness wounds in dystrophic and junctional epidermolysis bullosa. For hospital pharmacies, specialist centres and rare disease importers.

Product Description:

Birch triterpenes gel is a topical product made from a dry extract of birch bark, rich in pentacyclic triterpenes such as betulin, suspended in sunflower oil to form an oleogel at 10% w/w. It contains no water. The extract is thought to support wound healing by modulating inflammatory signals and helping keratinocytes migrate and differentiate, so the outer skin layer closes. The gel form lets it be spread on fragile, blistered skin, or on the dressing, at each dressing change without rubbing.

Its approved use is partial-thickness wounds in dystrophic and junctional epidermolysis bullosa, rare inherited disorders in which skin blisters and tears with minimal friction, in patients aged six months and over. A layer about 1 mm thick goes on the clean wound and is covered with a sterile non-adhesive dressing, or is applied to the dressing itself, at each change until the wound heals. Wound complications, application-site reactions, itching and infection are the common adverse events. Specialist epidermolysis bullosa teams manage its use.

Sourcing notes. This is an orphan medicine with few authorisations, so most buyers will work through a local marketing authorisation, a named-patient route or an unregistered-medicines import licence for a specific centre. Ask which applies and who acts as importer of record. Tubes are single-patient items; follow the label on use after opening and on storage temperature, and check transport conditions with the supplier. Request the batch CoA, including microbial quality and triterpene content, the GMP certificate and a CoPP. State tube size, tubes per patient month and the treating centre.