Miltefosine bulk supplier for pharma manufacturers

Miltefosine Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 10 mg, 50 mg

Reference Brands: Impavido (USA/EU)

Category: Anti-fungal

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. Miltefosine is available in Capsules and strengths such as 10 mg, 50 mg. 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, Miltefosine 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)

Miltefosine 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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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.

Yes, Miltefosine 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, Miltefosine 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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