Global B2B Pharmaceutical Sourcing · Dossier Licensing · Named-Patient Access
💬 WhatsApp · Sign in · Register
Sirolimus Gel bulk supplier for pharma manufacturers

Sirolimus Gel 0.2% gel Suppliers & Bulk Manufacturers

Available Forms: Gel

Available Strengths: 0.2% gel

Reference Brands: HYFTOR (USA)

Category: Derma Drugs

Sirolimus topical gel is a mTOR (mechanistic target of rapamycin) inhibitor formulated for cutaneous application. It is indicated for the treatment of facial angiofibromas associated with tuberous sclerosis complex (TSC) in patients aged 2 years and older. The gel works by inhibiting abnormal cell growth and proliferation, helping to reduce the size, redness, and thickness of skin lesions.

Ask About Access

Usually answered within 48 hours | GMP documents shared before you commit

Manufacture or export Sirolimus Gel? List it or send an offer →

Product Description:

Sirolimus inhibits mTOR, a kinase that integrates growth signals and drives cell proliferation. In tuberous sclerosis complex the TSC1 or TSC2 gene is defective, the brake on mTOR is missing, and the pathway runs unchecked — producing benign tumours in multiple organs, including the facial angiofibromas that appear across the nose and cheeks in childhood. Applying the inhibitor directly to the skin blocks that pathway where the lesions are, without the systemic immunosuppression that oral sirolimus causes.

The 0.2% gel is used for facial angiofibromas associated with tuberous sclerosis complex in patients aged two and over, applied thinly once daily. Lesions become less red, less raised and smaller over months of continued use, and they recur if treatment stops. This matters more than a cosmetic framing suggests: the lesions are disfiguring, highly visible, and appear during childhood. Application site irritation, dryness and stinging are the common effects; systemic absorption is low but measurable.

Sourcing notes. Originator product, on patent, with approval in a limited number of territories — confirm before quoting. A rare-disease dermatology product with small volumes through specialist clinics. Note this is a topical product and is in no way interchangeable with oral sirolimus. Store as labelled; confirm refrigeration requirements per presentation.

Also known as: sirólimus (Spanish), sirolimo (Portuguese), sirolimus (French, Italian, Turkish, Vietnamese), Sirolimus (German), сиролимус (Russian), سيروليموس (Arabic), 西罗莫司 (Chinese), シロリムス (Japanese), 시롤리무스 (Korean).

How Sirolimus Gel is supplied today, and licensing ahead of patent expiry

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
Ask about Sirolimus Gel supply →
Back to Listing

Frequently Asked Questions

Hyftor (Sirolimus 0.2% Gel) is developed and sold by Nobelpharma (Rapalimus gel in Japan). 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.

El gel de sirólimus al 0,2 % es un inhibidor de mTOR de uso tópico indicado para el angiofibroma facial asociado al complejo de esclerosis tuberosa en adultos y niños a partir de 6 años, según la ficha técnica aprobada. Es un medicamento con receta que se utiliza bajo la supervisión de un médico, normalmente un dermatólogo. PharmaTradz ayuda a importadores con licencia, distribuidores y hospitales a abastecerse de gel de sirólimus de fabricantes con certificación GMP.

O gel de sirolimo 0,2% é um inibidor de mTOR de uso tópico indicado para o angiofibroma facial associado ao complexo da esclerose tuberosa em adultos e crianças a partir de 6 anos, conforme a bula aprovada. É um medicamento sob prescrição, utilizado com acompanhamento médico, geralmente de um dermatologista. A PharmaTradz ajuda importadores autorizados, distribuidores e hospitais a adquirir gel de sirolimo de fabricantes com certificação GMP.

Le gel de sirolimus à 0,2 % est un inhibiteur de mTOR à usage cutané indiqué dans l'angiofibrome facial associé à la sclérose tubéreuse de Bourneville, chez l'adulte et l'enfant à partir de 6 ans, selon le résumé des caractéristiques du produit. C'est un médicament sur ordonnance, utilisé sous surveillance médicale, généralement celle d'un dermatologue. PharmaTradz aide les importateurs agréés, les distributeurs et les hôpitaux à s'approvisionner en gel de sirolimus auprès de fabricants certifiés GMP.

Related Products

Monosulfiram Medicated Soap

Strength:
5%

Form: Soap

Reference Brands: -

View Details
Polidocanol Injection

Strength:
0.25%, 0.5%, 1%, 2%, 3%

Form: Injection

Reference Brands: Asclera (USA), Aethoxysklerol (EU/UK/LATAM)

View Details
Salicylic Acid

Strength:
10%, 20% w/w

Form: Ointment

Reference Brands: -

View Details
Tretinoin

Strength:
0.05% w/w

Form: Cream

Reference Brands:

View Details
Butenafine Hydrochloride

Strength:
1%

Form: Creams

Reference Brands: Lotrimin Ultra (USA), Mentax (USA/EU)

View Details
Clocortolone Pivalate

Strength:
0.1%

Form: Creams

Reference Brands: Cloderm (USA)

View Details
Crotamiton

Strength:
10%

Form: Creams / Lotion

Reference Brands: Eurax (USA/EU)

View Details
DaxibotulinumtoxinA-Lanm

Strength:
50U, 100U

Form: Injection

Reference Brands: Daxxify(USA)

View Details
Enquire Now

Usually answered within 48 hours | GMP documents shared before you commit

Subscribe to Our Newsletter

Stay updated on pharma trends and sourcing opportunities.

Please enter the correct answer.
This website uses cookies to ensure you get the best experience. By using our site, you agree to our Privacy Policy.
WhatsApp us