Miltefosine bulk supplier for pharma manufacturers

Miltefosine 10 mg, 50 mg Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 10 mg, 50 mg

Reference Brands: Impavido (USA/EU)

Miltefosine is an oral antiprotozoal agent used to treat visceral, cutaneous, and mucosal leishmaniasis. It works by disrupting cell membrane phospholipid metabolism in Leishmania parasites, leading to parasite death. It is also used as part of combination therapy for rare amoebic infections. The treatment is taken orally for several weeks and requires monitoring for gastrointestinal effects and liver or kidney function changes. It should not be used during pregnancy due to teratogenic risks.

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Product Description:

Miltefosine is an alkylphosphocholine, originally developed as an anticancer agent, and it is an antiprotozoal rather than an antifungal. It interferes with lipid metabolism and membrane signalling in Leishmania parasites, disrupting their cell membranes and triggering programmed cell death. Its importance is simple: it is the only oral treatment for leishmaniasis, a disease otherwise treated with painful injectable antimonials or intravenous amphotericin.

It is used for visceral, cutaneous and mucocutaneous leishmaniasis, in a course of around twenty-eight days. Visceral leishmaniasis is fatal untreated and affects some of the poorest populations in South Asia, East Africa and Brazil, so an oral option changes what treatment programmes can deliver. Two constraints matter: it is teratogenic, so pregnancy must be excluded and effective contraception used during and for months after treatment, and because a full course is taken at home, incomplete adherence risks resistance. Vomiting and diarrhoea are very common.

Sourcing notes. Access has largely run through WHO and donation programmes rather than commercial channels, and registration outside endemic regions is limited. This product belongs under antiparasitic, not antifungal.

Miltefosine — third party manufacturing & bulk supply

Miltefosine 10 mg, 50 mg 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.

Indicative minimum order quantity

Miltefosine is supplied as Capsules — an oral solid dosage form, so the indicative MOQ is 200,000 units. Actual MOQ is confirmed by the allocated manufacturer against your pack presentation and destination market. See full supply terms for dossier formats, market availability and shelf life.

Manufacturers of Miltefosine listed on PharmaTradz hold site-level approvals across WHO-GMP, EU-GMP, USFDA, ANVISA and TGA, verified at onboarding.

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Frequently Asked Questions

Miltefosine is used for the treatment of leishmaniasis, including visceral, cutaneous, and mucocutaneous forms. It is also sometimes used for certain rare amoebic infections such as Naegleria fowleri.

Miltefosine is a synthetic alkylphosphocholine compound designed to disrupt parasite cell membranes and inhibit their metabolic pathways.

The commonly known trade name is Impavido.

Miltefosine is produced by several manufacturers globally, with Impavido originally developed by Aeterna Zentaris and later marketed by other licensed pharmaceutical companies.

The generic name is miltefosine.

The brand name is Impavido.

Miltefosine is manufactured by various pharmaceutical companies in India and other regions that specialize in anti-parasitic and neglected tropical disease medicines.